Multiple Myeloma
Conditions
Brief summary
The purpose of the study is to characterize safety of JNJ-68284528 and establish the recommended Phase 2 dose (RP2D) (Phase 1b) and to evaluate the efficacy of JNJ-68284528 (Phase 2).
Detailed description
This study will evaluate the safety and efficacy of JNJ-68284528. The study will include two phases. In Phase1b the study will enroll adults with multiple myeloma with interval assessments for potential dose escalation or de-escalation in subsequent participants. The dose selected at the completion of phase 1b will be used in Phase 2. Following consent, enrolled participants will undergo an apheresis procedure to collect cells for manufacture of investigational drug product (JNJ-68284528). Following manufacture of the drug product, participants will undergo lymphodepletion prior to infusion of JNJ-68284528. Participants will be followed for at least 2 years after study drug infusion, with long-term 15 year follow-up on a separate study. The study will evaluate safety, biomarkers, pharmacokinetic/pharmacodynamic evaluations and efficacy.
Interventions
BIOLOGICALJNJ-68284528
JNJ-68284528 consist of autologous T lymphocytes transduced with LCAR-B38M, a lentiviral vector to express a chimeric antigen receptor targeting the human B cell maturation antigen (anti-BCMA CAR).
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have documented diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria * Have measurable disease at Screening as defined by any of the following a) Serum monoclonal paraprotein (M-protein) level more than or equal to (\>=) 1.0 gram per deciliter(g/dL) or urine M-protein level \>=200 milligram per 24 hours (mg/24hr); or b) Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio * Have received at least 3 prior multiple myeloma treatment lines of therapy or are double refractory to an immunomodulatory drug (IMiD) and proteasome inhibitor (PI) (refractory multiple myeloma as defined by IMWG consensus criteria). Note: induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single lines of therapy a) Undergone at least 1 complete cycle of treatment for each line of therapy, unless progressive disease (PD) was the best response to the regimen * Have received as part of previous therapy a PI, an IMiD, and an anti-CD38 antibody * Participant must have documented evidence of progressive disease based on investigator's determination of response by the IMWG criteria on or within 12 months of their last line of therapy. Confirmation may be from either central or local testing. Also, participants with documented evidence of progressive disease (as above) within the previous 6 months and who are refractory or non-responsive to their most recent line of therapy afterwards are eligible * Have Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1
Exclusion criteria
* Have received prior treatment with chimeric antigen receptor T (CAR-T) therapy directed at any target * Have received any therapy that is targeted to B-cell maturation antigen (BCMA) * Have following cardiac conditions: a) New York Heart Association (NYHA) stage III or IV congestive heart failure b) Myocardial infarction or coronary artery bypass graft (CABG) less than or equal to (\<=) 6 months prior to enrollment c) History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration d) History of severe non-ischemic cardiomyopathy e) Impaired cardiac function (left ventricular ejection fraction \[LVEF\] less than \[\<\]45%) as assessed by echocardiogram or multiple-gated acquisition (MUGA) scan (performed less than or equal to (\<=) 8 weeks of apheresis) * Received a cumulative dose of corticosteroids equivalent to \>= 70 mg of prednisone within the 7 days prior to apheresis * Have received either of the following: a) An allogenic stem cell transplant within 6 months before apheresis. Participants who received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease (GVHD) b) An autologous stem cell transplant less than or equal to (\<=) 12 weeks before apheresis * Have known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1b: Number of Participants With Adverse Events as Per Severity | Day 1 up to 45.2 months | An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. |
| Phase 2: Overall Response Rate (ORR) | Day 1 up to 45.2 months | ORR was defined as the percentage of participants who achieved partial response (PR) or better according to international myeloma working group (IMWG) criteria. IMWG criteria for PR: greater than or equal to (\>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to less than (\<) 200 milligrams (mg) per 24 hours. If the serum and urine M-protein were not measurable, a decrease of \>=50% in the difference between involved and uninvolved free light chain (FLC) levels was required in place of the M-protein criteria. If serum and urine M-protein were not measurable, and serum free light assay was also not measurable, \>=50% reduction in bone marrow plasma cells (PCs) was required in place of M-protein, provided baseline bone marrow PC percentage was \>=30%. In addition to the above criteria, if present at baseline, a \>=50% reduction in the size of soft tissue plasmacytomas was also required. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1b and Phase 2: Actual Sampling Time of Last Measurable Analyte Concentration (Tlast) of JNJ-68284528 Transgene | Pre and post dose on Day 1 and Days 2, 3, 7, 10, 14, 21, 28, 42, 56, 78, 100, then every 4 weeks up to 1 year, and at the time of progressive disease or at study completion for participants without progressive disease (up to approximately 2.5 years) | Tlast was defined as actual sampling time of last measurable (non-below quantification limit \[BQL\]) analyte concentration of JNJ-68284528 transgene. |
| Phase 1b and Phase 2: Area Under the Plasma Concentration Versus Time Curve From Time 0 To Last Measurable Concentration (AUC0-last) of JNJ-68284528 Transgene | Pre and post dose on Day 1; Days 2, 3, 7, 10, 14, 21, 28, 42, 56, 78, 100, then every 4 weeks up to 1 year, and at the time of progressive disease or at study completion for participants without progressive disease (up to approximately 2.5 years) | Area under the plasma concentration versus time curve from time 0 to last measurable concentration of JNJ-68284528 transgene was reported. |
| Phase 1b and Phase 2: Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinite Time (AUC0-infinity) of JNJ-68284528 Transgene | Pre and post dose on Day 1 and Days 2, 3, 7, 10, 14, 21, 28, 42, 56, 78, 100, then every 4 weeks up to 1 year, and at the time of progressive disease or at study completion for participants without progressive disease (up to approximately 2.5 years) | Area under the plasma concentration versus time curve from time 0 to infinite time of JNJ-68284528 transgene was reported. |
| Phase 1b and Phase 2: Maximum Observed Plasma Concentration (Cmax) of CD3+CAR+ Cells in Blood After a Single Infusion of JNJ-68284528 | Pre and post dose on Day 1 and Days 2, 3, 7, 10, 14, 21, 28, 42, 56, 78, 100, then every 4 weeks up to 1 year, and at the time of progressive disease or at study completion for participants without progressive disease (up to approximately 2.5 years) | Maximum observed plasma concentration (Cmax) of CD3+CAR+ Cells was reported. Cmax was calculated in cells per microliter. |
| Phase 1b and Phase 2: T Cell Persistence After a Single Infusion of JNJ-68284528 | Pre and post dose on Day 1 and Days 2, 3, 7, 10, 14, 21, 28, 42, 56, 78, 100, then every 4 weeks up to 1 year, and at the time of progressive disease or at study completion for participants without progressive disease (up to approximately 2.5 years) | T Cell persistence after a single infusion of JNJ-68284528 was reported. T Cell persistence was defined as actual sampling time of last measurable (non-below quantification limit \[BQL\]) analyte concentration. |
| Phase 1b and Phase 2: Area Under the Plasma Concentration Versus Time Curve From Time 0 To Last Measurable Concentration (AUC0-last) of CD3+CAR+ Cells in Blood After a Single Infusion of JNJ-68284528 | Pre and post dose on Day 1 and Days 2, 3, 7, 10, 14, 21, 28, 42, 56, 78, 100, then every 4 weeks up to 1 year, and at the time of progressive disease or at study completion for participants without progressive disease (up to approximately 2.5 years) | Area under the plasma concentration versus time curve from time 0 to last measurable concentration of CD3+CAR+ Cells was reported. |
| Phase 1b and Phase 2: Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinite Time (AUC0-infinity) of CD3+CAR+ Cells in Blood After a Single Infusion of JNJ-68284528 | Pre and post dose on Day 1 and Days 2, 3, 7, 10, 14, 21, 28, 42, 56, 78, 100, then every 4 weeks up to 1 year, and at the time of progressive disease or at study completion for participants without progressive disease (up to approximately 2.5 years) | Area under the plasma concentration versus time curve from time 0 to infinite time of CD3+CAR+ Cells in blood after a single infusion of JNJ-68284528 was reported. |
| Phase 1b and Phase 2: Mean Concentration of Soluble B-cell Maturation Antigen (BCMA) Levels in Serum After Single Infusion of JNJ-68284528 | Days 352 and 1024 | Mean concentration of soluble BCMA levels in serum after single infusion of JNJ-68284528 were reported. |
| Number of Participants With Depletion of BCMA Expressing Cells | Pre dose (Day 1) up to 2 years | Number of participants with depletion of BCMA expressing cells were reported. |
| Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Pre-infusion and 2 hours post infusion on Day 1, Days 2, 3, 7, 10, 14, 21, 28, 42, 56, 78, 100 | Serum systemic cytokine concentrations (Interleukin \[IL\]-6, IL-10, and Interferon Gamma \[IFN-g\]) were reported. |
| Phase 1b and Phase 2: Maximum Observed Plasma Concentration (Cmax) of CAR-T Cells (CD3+CAR+ Cells in Blood) After a Single Infusion of JNJ-68284528 | Pre and post dose on Day 1 and Days 2, 3, 7, 10, 14, 21, 28, 42, 56, 78, 100, then every 4 weeks up to 1 year, and at the time of progressive disease or at study completion for participants without progressive disease (up to approximately 2.5 years) | Cmax of CAR-T cells (CD3+CAR+ cells in blood) after a single infusion of JNJ-68284528 was reported. |
| Phase 1b and Phase 2: Maximum T Cell Expansion After a Single Infusion of JNJ-68284528 | Pre and post dose on Day 1 and Days 2, 3, 7, 10, 14, 21, 28, 42, 56, 78, 100, then every 4 weeks up to 1 year, and at the time of progressive disease or at study completion for participants without progressive disease (up to approximately 2.5 years) | Maximum T cell expansion was defined as maximum observed plasma concentration (Cmax) after a single Infusion of JNJ-68284528. |
| Phase 1b and Phase 2: Percentage of Participants With Positive Antibodies to JNJ-68284528 | Pre dose (Day 1) up to 2 years | Percentage of participants with positive antibodies to JNJ-68284528 were reported. |
| Phase 1b and Phase 2: Very Good Partial Response (VGPR) or Better Response Rate | Pre dose (Day 1) up to 45.2 months | VGPR or better response rate was defined as the percentage of participants who achieved VGPR or complete response (CR) (including stringent complete response \[sCR\]) according to the IMWG criteria during or after the study treatment. VGPR: Serum and urine component detectable by immunofixation but not on electrophoresis, or \>= 90% reduction in serum M-protein plus urine M-protein level less than (\<) 100 mg/24 hour; CR: negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and \<5% PCs in bone marrow; sCR: CR in addition to having a normal free light chain (FLC) ratio and an absence of clonal cells in bone marrow by immunohistochemistry, immunofluorescence, 2-4 color flow cytometry. |
| Phase 1b and Phase 2: Minimal Residual Disease (MRD) Negative Rate | Pre dose (Day 1) up to 45.2 months | MRD negativity rate was defined as percentage of participants who had negative MRD by bone marrow aspirate at any timepoint after initial dose of JNJ-68284528 and before disease progression or starting subsequent therapy or retreatment with JNJ-68284528. MRD negativity rate was assessed by next-generation sequencing at a threshold of \<10\^5. |
| Phase 2: Number of Participants With Adverse Events (AEs) as Per Severity | Day 1 up to 45.2 months | An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Severity was graded according to the NCI-CTCAE version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. |
| Phase 1b and Phase 2: Duration of Response (DOR) | Pre dose (Day 1) up to first documented PD or death (up to 45.2 months) | DOR was defined as the time (in months) from the date of initial documented response (PR or better response) to the date of first documented evidence of progressive disease (PD) or death. PD is defined as an increase of 25% from the lowest response value in one of the following: serum and urine M-component (absolute increase must be \>=0.5 gram per deciliter \[g/dL\] and \>=200 mg/24 hours respectively); only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels (absolute increase must be \>10 mg/dL); definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that can be attributed solely to PC proliferative disorder, appearance of a new lesion(s), \>=50% increase in circulating plasma cells if this was the only measure of disease. |
| Phase 1b and Phase 2: Time to First Response | Pre dose (Day 1) up to 45.2 months | Time to first response was defined as the time between date of the initial infusion of JNJ-68284528 and the first efficacy evaluation that the participant met all criteria for PR or better. IMWG criteria for PR: \>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or \<200 mg per 24 hours, If the serum and urine M-protein are not measurable, a decrease of \>=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, \>=50% reduction in bone marrow PCs is required in place of M-protein, provided baseline bone marrow plasma cell percentage was \>=30%. In addition to the above criteria, if present at baseline, a \>=50% reduction in the size of soft tissue plasmacytomas is also required. |
| Phase 1b and Phase 2: Progression-free Survival (PFS) | Pre dose (Day 1) up to 45.2 months | Progression-free survival was defined as the time from the date of the initial infusion of JNJ-68284528 to the date of first documented disease progression. |
| Phase 1b and Phase 2: Overall Survival | Pre dose (Day 1) up to 45.2 months | Overall survival was defined as the time from the date of the initial infusion of JNJ-68284528 to the date of the participant's death. |
| Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Baseline, Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | EQ-5D-5L was a 5-item questionnaire consisted of 2 components: a health state profile/a single utility index value and an optional VAS. EQ-5D health state profile/a single utility index value had 5 dimensions including mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 5 response levels: 1 =no problems, 2 =slight problems, 3 =moderate problems, 4 =severe problems and 5 =extreme problems. The scores for the 5 dimensions were used to compute a single utility score ranging from 0 to 1 representing the general health status of the individual. Higher score indicated better health status. EQ-5D VAS was used to record participant's rating for his/her health today and ranging from 0 to 100, where 0 = worst imaginable health state and 100 = best imaginable health state. |
| Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Baseline, Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | EQ-5D-5L was a 5-item questionnaire consisted of 2 components: a health state profile/a single utility index value and an optional VAS. EQ-5D health state profile/a single utility index value had 5 dimensions including mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 5 response levels: 1 =no problems, 2 =slight problems, 3 =moderate problems, 4 =severe problems and 5 =extreme problems. The scores for the 5 dimensions were used to compute a single utility score ranging from 0 to 1 representing the general health status of the individual. Higher score indicated better health status. EQ-5D VAS was used to record participant's rating for his/her health today and ranging from 0 to 100, where 0 = worst imaginable health state and 100 = best imaginable health state. |
| Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Baseline, Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | EQ-5D-5L was a 5-item questionnaire consisted of 2 components: a health state profile/a single utility index value and an optional VAS. EQ-5D health state profile/a single utility index value had 5 dimensions including mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 5 response levels: 1 =no problems, 2 =slight problems, 3 =moderate problems, 4 =severe problems and 5 =extreme problems. The scores for the 5 dimensions were used to compute a single utility score ranging from 0 to 1 representing the general health status of the individual. Higher score indicated better health status. EQ-5D VAS was used to record participant's rating for his/her health today and ranging from 0 to 100, where 0 =worst imaginable health state and 100 = best imaginable health state. |
| Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Baseline, Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | EQ-5D-5L was a 5-item questionnaire consisted of 2 components: a health state profile/a single utility index value and an optional VAS. EQ-5D health state profile/a single utility index value had 5 dimensions including mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 5 response levels: 1 =no problems, 2 =slight problems, 3 =moderate problems, 4 =severe problems and 5 =extreme problems. The scores for the 5 dimensions were used to compute a single utility score ranging from 0 to 1 representing the general health status of the individual. Higher score indicated better health status. EQ-5D VAS was used to record participant's rating for his/her health today and ranging from 0 to 100, where 0 = worst imaginable health state and 100 = best imaginable health state. |
| Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Baseline, Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | EORTC QLQ-C30 was a 30 items self-reporting questionnaire, with 1 week recall period, resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 Global Health Status scale (GHS), 3 symptom scales (fatigue, nausea and vomiting, and pain) and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Questionnaire includes 28 items with 4-point Likert type responses from 1-not at all to 4-very much to assess functioning and symptoms;2 items with 7-point Likert scales (1= poor and 7= excellent) for global health and overall health related QoL. Scores are transformed to 0 to 100 scale, with higher scores representing better GHS, better functioning, and more symptoms. Negative change from baseline values shows deterioration in quality of life or functioning and reduction in symptom and positive values indicate improvement and worsening of symptoms. |
| Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Baseline, Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | EORTC QLQ-C30 was a 30 items self-reporting questionnaire, with 1 week recall period, resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 Global Health Status scale (GHS), 3 symptom scales (fatigue, nausea and vomiting, and pain) and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Questionnaire includes 28 items with 4-point Likert type responses from 1-not at all to 4-very much to assess functioning and symptoms;2 items with 7-point Likert scales (1= poor and 7= excellent) for global health and overall health related QoL. Scores are transformed to 0 to 100 scale, with higher scores representing better GHS, better functioning, and more symptoms. Negative change from baseline values shows deterioration in quality of life or functioning and reduction in symptom and positive values indicate improvement and worsening of symptoms. |
| Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 | Baseline, Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 | PGIS was a single item to assess severity of pain on a 5-point verbal rating scale ranged from 1 (no pain) to 5 (very severe pain), where 1: none; 2: mild; 3: moderate; 4: severe; 5: very severe. A higher score indicated a more severe pain. |
| Phase 2: Patient Global Impression of Change (PGIC) Score at Days 28, 56, 78, 100 | Days 28, 56, 78, 100 | PGIC was a single item to assess the participant's perception in change of their overall health status using a 7-point verbal rating scale ranging from 1(a lot better now) to 7 (a lot verse now), where 1: a lot better now; 2: moderately better now; 3: a little better now; 4: neither better nor worse; 5: a little worse now; 6: moderately worse now; 7: a lot worse now. Higher score indicated worse health status. |
| Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Baseline, Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | EORTC QLQ-MY20 scale comprised of 20 questions that addressed four myeloma-specific HRQoL domains: disease symptoms (includes bone aches or pain, back pain, hip pain, arm or shoulder pain, chest pain, and pain increasing with activity), side effects of treatment (includes drowsiness, thirst, feeling ill, dry mouth, hair loss, upset by hair loss, tingling hands or feet, restlessness/agitation, acid indigestion/heartburn, and burning or sore eyes), future perspective (includes worry about death and health in the future, and thinking about illness) and body image. The scale was administered to assess 4 single items: feel restless or agitated, thinking about your illness, worried about dying, worried about health in the future. Scores were averaged and scales were transformed on a 0 to 100 scale. A high score for side effects of treatment represented a high level of symptomatology or problems, whereas a high score for future perspective represented better outcomes. |
| Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Baseline, Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | EORTC QLQ-MY20 scale comprised of 20 questions that addressed four myeloma-specific HRQoL domains: disease symptoms (includes bone aches or pain, back pain, hip pain, arm or shoulder pain, chest pain, and pain increasing with activity), side effects of treatment (includes drowsiness, thirst, feeling ill, dry mouth, hair loss, upset by hair loss, tingling hands or feet, restlessness/agitation, acid indigestion/heartburn, and burning or sore eyes), future perspective (includes worry about death and health in the future, and thinking about illness) and body image. The scale was administered to assess 4 single items: feel restless or agitated, thinking about your illness, worried about dying, worried about health in the future. Scores were averaged and scales were transformed on a 0 to 100 scale. A high score for side effects of treatment represented a high level of symptomatology or problems, whereas a high score for future perspective represented better outcomes. |
| Phase 1b and Phase 2: Clinical Benefit Rate (CBR) | Pre dose (Day 1) up to 45.2 months | Clinical benefit rate was defined as the percentage of participants with best response of minimal response (MR) or better (including sCR, CR, VGPR, PR, and MR). MR was defined as \>=25% but less than or equal to (\<=) 49% reduction of serum M-protein and reduction in 24-hour urine M-protein by 50% to 89%. In addition to the above criteria, if present at baseline, \>=50% reduction in the size of soft tissue plasmacytomas was also required. |
| Phase 1b and Phase 2: Maximum Observed Plasma Concentration (Cmax) of JNJ-68284528 Transgene | Pre and post dose on Day 1, and Days 2, 3, 7, 10, 14, 21, 28, 42, 56, 78, 100, then every 4 weeks up to 1 year, and at the time of progressive disease or at study completion for participants without progressive disease (up to approximately 2.5 years) | Maximum observed plasma concentration (Cmax) of JNJ-68284528 transgene was reported. Cmax was calculated in copies per microgram (mcg) genomic deoxyribonucleic acid (DNA). |
Countries
Japan, United States
Participant flow
Pre-assignment details
As planned, data for Phase 2 participants were reported separately for US population (78 participants) and Japan population (13 participants).
Participants by arm
| Arm | Count |
|---|---|
| Phase 1b (US Population) Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\*10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\*10\^6 CAR-positive viable cells/kg) as IV infusion. | 29 |
| Phase 2 (US Population) Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received recommended phase 2 dose (RP2D) dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion. | 68 |
| Phase 2 (Japan Population) Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion. | 9 |
| Total | 106 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 10 | 23 | 3 |
| Overall Study | Lost to Follow-up | 0 | 2 | 0 |
| Overall Study | Randomized but not treated | 6 | 10 | 4 |
| Overall Study | Sponsor decision | 19 | 40 | 6 |
| Overall Study | Withdrawal by Subject | 0 | 3 | 0 |
Baseline characteristics
| Characteristic | Phase 1b (US Population) | Phase 2 (US Population) | Phase 2 (Japan Population) | Total |
|---|---|---|---|---|
| Age, Continuous | 60.9 Years STANDARD_DEVIATION 6.42 | 62.5 Years STANDARD_DEVIATION 9.09 | 58.9 Years STANDARD_DEVIATION 8.87 | 61.7 Years STANDARD_DEVIATION 8.42 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 9 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 12 Participants | 0 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 6 Participants | 0 Participants | 8 Participants |
| Race (NIH/OMB) White | 20 Participants | 49 Participants | 0 Participants | 69 Participants |
| Region of Enrollment Japan | 0 Participants | 0 Participants | 9 Participants | 9 Participants |
| Region of Enrollment United States | 29 Participants | 68 Participants | 0 Participants | 97 Participants |
| Sex: Female, Male Female | 15 Participants | 25 Participants | 4 Participants | 44 Participants |
| Sex: Female, Male Male | 14 Participants | 43 Participants | 5 Participants | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 10 / 29 | 25 / 68 | 3 / 9 |
| other Total, other adverse events | 29 / 29 | 68 / 68 | 9 / 9 |
| serious Total, serious adverse events | 11 / 29 | 42 / 68 | 1 / 9 |
Outcome results
Primary
Phase 1b: Number of Participants With Adverse Events as Per Severity
An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Time frame: Day 1 up to 45.2 months
Population: All treated analysis set included all participants who received JNJ-68284528 infusion.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1b (US Population) | Phase 1b: Number of Participants With Adverse Events as Per Severity | Grade 1 | 0 Participants |
| Phase 1b (US Population) | Phase 1b: Number of Participants With Adverse Events as Per Severity | Grade 2 | 0 Participants |
| Phase 1b (US Population) | Phase 1b: Number of Participants With Adverse Events as Per Severity | Grade 3 | 2 Participants |
| Phase 1b (US Population) | Phase 1b: Number of Participants With Adverse Events as Per Severity | Grade 4 | 26 Participants |
| Phase 1b (US Population) | Phase 1b: Number of Participants With Adverse Events as Per Severity | Grade 5 | 1 Participants |
Primary
Phase 2: Overall Response Rate (ORR)
ORR was defined as the percentage of participants who achieved partial response (PR) or better according to international myeloma working group (IMWG) criteria. IMWG criteria for PR: greater than or equal to (\>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to less than (\<) 200 milligrams (mg) per 24 hours. If the serum and urine M-protein were not measurable, a decrease of \>=50% in the difference between involved and uninvolved free light chain (FLC) levels was required in place of the M-protein criteria. If serum and urine M-protein were not measurable, and serum free light assay was also not measurable, \>=50% reduction in bone marrow plasma cells (PCs) was required in place of M-protein, provided baseline bone marrow PC percentage was \>=30%. In addition to the above criteria, if present at baseline, a \>=50% reduction in the size of soft tissue plasmacytomas was also required.
Time frame: Day 1 up to 45.2 months
Population: Modified intent-to-treat (mITT) analysis set included all participants who received a JNJ-68284528 infusion at the targeted recommended phase 2 dose (RP2D) dose level. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1b (US Population) | Phase 2: Overall Response Rate (ORR) | 97.1 Percentage of participants |
| Phase 2 (Japan Population) | Phase 2: Overall Response Rate (ORR) | 100.0 Percentage of participants |
Secondary
Number of Participants With Depletion of BCMA Expressing Cells
Number of participants with depletion of BCMA expressing cells were reported.
Time frame: Pre dose (Day 1) up to 2 years
Population: mITT analysis set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure. Due to change in planned analysis, data was not collected and analyzed for Phase 2 (Japan Population) in this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1b (US Population) | Number of Participants With Depletion of BCMA Expressing Cells | 0 Participants |
| Phase 2 (Japan Population) | Number of Participants With Depletion of BCMA Expressing Cells | 0 Participants |
Secondary
Phase 1b and Phase 2: Actual Sampling Time of Last Measurable Analyte Concentration (Tlast) of JNJ-68284528 Transgene
Tlast was defined as actual sampling time of last measurable (non-below quantification limit \[BQL\]) analyte concentration of JNJ-68284528 transgene.
Time frame: Pre and post dose on Day 1 and Days 2, 3, 7, 10, 14, 21, 28, 42, 56, 78, 100, then every 4 weeks up to 1 year, and at the time of progressive disease or at study completion for participants without progressive disease (up to approximately 2.5 years)
Population: mITT analysis set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1b (US Population) | Phase 1b and Phase 2: Actual Sampling Time of Last Measurable Analyte Concentration (Tlast) of JNJ-68284528 Transgene | 127.13 Days |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Actual Sampling Time of Last Measurable Analyte Concentration (Tlast) of JNJ-68284528 Transgene | 122.98 Days |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Actual Sampling Time of Last Measurable Analyte Concentration (Tlast) of JNJ-68284528 Transgene | 129.89 Days |
Secondary
Phase 1b and Phase 2: Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinite Time (AUC0-infinity) of CD3+CAR+ Cells in Blood After a Single Infusion of JNJ-68284528
Area under the plasma concentration versus time curve from time 0 to infinite time of CD3+CAR+ Cells in blood after a single infusion of JNJ-68284528 was reported.
Time frame: Pre and post dose on Day 1 and Days 2, 3, 7, 10, 14, 21, 28, 42, 56, 78, 100, then every 4 weeks up to 1 year, and at the time of progressive disease or at study completion for participants without progressive disease (up to approximately 2.5 years)
Population: mITT analysis set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1b (US Population) | Phase 1b and Phase 2: Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinite Time (AUC0-infinity) of CD3+CAR+ Cells in Blood After a Single Infusion of JNJ-68284528 | 10937 Days*cells per microliter | Standard Deviation 8658 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinite Time (AUC0-infinity) of CD3+CAR+ Cells in Blood After a Single Infusion of JNJ-68284528 | 31966 Days*cells per microliter | Standard Deviation 58976 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinite Time (AUC0-infinity) of CD3+CAR+ Cells in Blood After a Single Infusion of JNJ-68284528 | 7144.5 Days*cells per microliter | Standard Deviation 5905 |
Secondary
Phase 1b and Phase 2: Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinite Time (AUC0-infinity) of JNJ-68284528 Transgene
Area under the plasma concentration versus time curve from time 0 to infinite time of JNJ-68284528 transgene was reported.
Time frame: Pre and post dose on Day 1 and Days 2, 3, 7, 10, 14, 21, 28, 42, 56, 78, 100, then every 4 weeks up to 1 year, and at the time of progressive disease or at study completion for participants without progressive disease (up to approximately 2.5 years)
Population: mITT analysis set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1b (US Population) | Phase 1b and Phase 2: Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinite Time (AUC0-infinity) of JNJ-68284528 Transgene | 542728 Day*copies per mcg genomic DNA | Standard Deviation 345847 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinite Time (AUC0-infinity) of JNJ-68284528 Transgene | 1321427 Day*copies per mcg genomic DNA | Standard Deviation 1513726 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinite Time (AUC0-infinity) of JNJ-68284528 Transgene | 7173538 Day*copies per mcg genomic DNA | Standard Deviation 12191640 |
Secondary
Phase 1b and Phase 2: Area Under the Plasma Concentration Versus Time Curve From Time 0 To Last Measurable Concentration (AUC0-last) of CD3+CAR+ Cells in Blood After a Single Infusion of JNJ-68284528
Area under the plasma concentration versus time curve from time 0 to last measurable concentration of CD3+CAR+ Cells was reported.
Time frame: Pre and post dose on Day 1 and Days 2, 3, 7, 10, 14, 21, 28, 42, 56, 78, 100, then every 4 weeks up to 1 year, and at the time of progressive disease or at study completion for participants without progressive disease (up to approximately 2.5 years)
Population: mITT analysis set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1b (US Population) | Phase 1b and Phase 2: Area Under the Plasma Concentration Versus Time Curve From Time 0 To Last Measurable Concentration (AUC0-last) of CD3+CAR+ Cells in Blood After a Single Infusion of JNJ-68284528 | 7758 Day*cells per microliter | Standard Deviation 7599 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Area Under the Plasma Concentration Versus Time Curve From Time 0 To Last Measurable Concentration (AUC0-last) of CD3+CAR+ Cells in Blood After a Single Infusion of JNJ-68284528 | 40073 Day*cells per microliter | Standard Deviation 79603 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Area Under the Plasma Concentration Versus Time Curve From Time 0 To Last Measurable Concentration (AUC0-last) of CD3+CAR+ Cells in Blood After a Single Infusion of JNJ-68284528 | 152904 Day*cells per microliter | Standard Deviation 361949 |
Secondary
Phase 1b and Phase 2: Area Under the Plasma Concentration Versus Time Curve From Time 0 To Last Measurable Concentration (AUC0-last) of JNJ-68284528 Transgene
Area under the plasma concentration versus time curve from time 0 to last measurable concentration of JNJ-68284528 transgene was reported.
Time frame: Pre and post dose on Day 1; Days 2, 3, 7, 10, 14, 21, 28, 42, 56, 78, 100, then every 4 weeks up to 1 year, and at the time of progressive disease or at study completion for participants without progressive disease (up to approximately 2.5 years)
Population: mITT analysis set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1b (US Population) | Phase 1b and Phase 2: Area Under the Plasma Concentration Versus Time Curve From Time 0 To Last Measurable Concentration (AUC0-last) of JNJ-68284528 Transgene | 588162 Day*copies per mcg genomic DNA | Standard Deviation 466441 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Area Under the Plasma Concentration Versus Time Curve From Time 0 To Last Measurable Concentration (AUC0-last) of JNJ-68284528 Transgene | 1356191 Day*copies per mcg genomic DNA | Standard Deviation 1673474 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Area Under the Plasma Concentration Versus Time Curve From Time 0 To Last Measurable Concentration (AUC0-last) of JNJ-68284528 Transgene | 4062950 Day*copies per mcg genomic DNA | Standard Deviation 7293651 |
Secondary
Phase 1b and Phase 2: Clinical Benefit Rate (CBR)
Clinical benefit rate was defined as the percentage of participants with best response of minimal response (MR) or better (including sCR, CR, VGPR, PR, and MR). MR was defined as \>=25% but less than or equal to (\<=) 49% reduction of serum M-protein and reduction in 24-hour urine M-protein by 50% to 89%. In addition to the above criteria, if present at baseline, \>=50% reduction in the size of soft tissue plasmacytomas was also required.
Time frame: Pre dose (Day 1) up to 45.2 months
Population: mITT analysis Set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1b (US Population) | Phase 1b and Phase 2: Clinical Benefit Rate (CBR) | 100.0 Percentage of participants |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Clinical Benefit Rate (CBR) | 97.1 Percentage of participants |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Clinical Benefit Rate (CBR) | 100.0 Percentage of participants |
Secondary
Phase 1b and Phase 2: Duration of Response (DOR)
DOR was defined as the time (in months) from the date of initial documented response (PR or better response) to the date of first documented evidence of progressive disease (PD) or death. PD is defined as an increase of 25% from the lowest response value in one of the following: serum and urine M-component (absolute increase must be \>=0.5 gram per deciliter \[g/dL\] and \>=200 mg/24 hours respectively); only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels (absolute increase must be \>10 mg/dL); definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that can be attributed solely to PC proliferative disorder, appearance of a new lesion(s), \>=50% increase in circulating plasma cells if this was the only measure of disease.
Time frame: Pre dose (Day 1) up to first documented PD or death (up to 45.2 months)
Population: Analysis population included responders (who achieved PR or better response) in mITT analysis set. mITT analysis set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1b (US Population) | Phase 1b and Phase 2: Duration of Response (DOR) | NA Months |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Duration of Response (DOR) | NA Months |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Duration of Response (DOR) | NA Months |
Secondary
Phase 1b and Phase 2: Maximum Observed Plasma Concentration (Cmax) of CAR-T Cells (CD3+CAR+ Cells in Blood) After a Single Infusion of JNJ-68284528
Cmax of CAR-T cells (CD3+CAR+ cells in blood) after a single infusion of JNJ-68284528 was reported.
Time frame: Pre and post dose on Day 1 and Days 2, 3, 7, 10, 14, 21, 28, 42, 56, 78, 100, then every 4 weeks up to 1 year, and at the time of progressive disease or at study completion for participants without progressive disease (up to approximately 2.5 years)
Population: mITT analysis set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1b (US Population) | Phase 1b and Phase 2: Maximum Observed Plasma Concentration (Cmax) of CAR-T Cells (CD3+CAR+ Cells in Blood) After a Single Infusion of JNJ-68284528 | 483 Cells per microliter | Standard Deviation 464 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Maximum Observed Plasma Concentration (Cmax) of CAR-T Cells (CD3+CAR+ Cells in Blood) After a Single Infusion of JNJ-68284528 | 1472 Cells per microliter | Standard Deviation 2085 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Maximum Observed Plasma Concentration (Cmax) of CAR-T Cells (CD3+CAR+ Cells in Blood) After a Single Infusion of JNJ-68284528 | 1614 Cells per microliter | Standard Deviation 3718 |
Secondary
Phase 1b and Phase 2: Maximum Observed Plasma Concentration (Cmax) of CD3+CAR+ Cells in Blood After a Single Infusion of JNJ-68284528
Maximum observed plasma concentration (Cmax) of CD3+CAR+ Cells was reported. Cmax was calculated in cells per microliter.
Time frame: Pre and post dose on Day 1 and Days 2, 3, 7, 10, 14, 21, 28, 42, 56, 78, 100, then every 4 weeks up to 1 year, and at the time of progressive disease or at study completion for participants without progressive disease (up to approximately 2.5 years)
Population: mITT analysis set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1b (US Population) | Phase 1b and Phase 2: Maximum Observed Plasma Concentration (Cmax) of CD3+CAR+ Cells in Blood After a Single Infusion of JNJ-68284528 | 483 Cells per microliter | Standard Deviation 464 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Maximum Observed Plasma Concentration (Cmax) of CD3+CAR+ Cells in Blood After a Single Infusion of JNJ-68284528 | 1472 Cells per microliter | Standard Deviation 2085 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Maximum Observed Plasma Concentration (Cmax) of CD3+CAR+ Cells in Blood After a Single Infusion of JNJ-68284528 | 1614 Cells per microliter | Standard Deviation 3718 |
Secondary
Phase 1b and Phase 2: Maximum Observed Plasma Concentration (Cmax) of JNJ-68284528 Transgene
Maximum observed plasma concentration (Cmax) of JNJ-68284528 transgene was reported. Cmax was calculated in copies per microgram (mcg) genomic deoxyribonucleic acid (DNA).
Time frame: Pre and post dose on Day 1, and Days 2, 3, 7, 10, 14, 21, 28, 42, 56, 78, 100, then every 4 weeks up to 1 year, and at the time of progressive disease or at study completion for participants without progressive disease (up to approximately 2.5 years)
Population: mITT analysis set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1b (US Population) | Phase 1b and Phase 2: Maximum Observed Plasma Concentration (Cmax) of JNJ-68284528 Transgene | 38965 copies per mcg genomic DNA | Standard Deviation 19408 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Maximum Observed Plasma Concentration (Cmax) of JNJ-68284528 Transgene | 52841 copies per mcg genomic DNA | Standard Deviation 29021 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Maximum Observed Plasma Concentration (Cmax) of JNJ-68284528 Transgene | 44077 copies per mcg genomic DNA | Standard Deviation 39911 |
Secondary
Phase 1b and Phase 2: Maximum T Cell Expansion After a Single Infusion of JNJ-68284528
Maximum T cell expansion was defined as maximum observed plasma concentration (Cmax) after a single Infusion of JNJ-68284528.
Time frame: Pre and post dose on Day 1 and Days 2, 3, 7, 10, 14, 21, 28, 42, 56, 78, 100, then every 4 weeks up to 1 year, and at the time of progressive disease or at study completion for participants without progressive disease (up to approximately 2.5 years)
Population: mITT analysis set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1b (US Population) | Phase 1b and Phase 2: Maximum T Cell Expansion After a Single Infusion of JNJ-68284528 | 483 Cells per microliter | Standard Deviation 464 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Maximum T Cell Expansion After a Single Infusion of JNJ-68284528 | 1472 Cells per microliter | Standard Deviation 2085 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Maximum T Cell Expansion After a Single Infusion of JNJ-68284528 | 1614 Cells per microliter | Standard Deviation 3718 |
Secondary
Phase 1b and Phase 2: Mean Concentration of Soluble B-cell Maturation Antigen (BCMA) Levels in Serum After Single Infusion of JNJ-68284528
Mean concentration of soluble BCMA levels in serum after single infusion of JNJ-68284528 were reported.
Time frame: Days 352 and 1024
Population: mITT analysis set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure. Zero (0) participants in the number analyzed field for arm Phase 2 (Japan Population) at Day 1024 signifies that no participants were available for the analysis because no sBCMA samples were collected and analyzed due to change in planned analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Phase 1b (US Population) | Phase 1b and Phase 2: Mean Concentration of Soluble B-cell Maturation Antigen (BCMA) Levels in Serum After Single Infusion of JNJ-68284528 | Day 352 | 2.25 Micrograms per liter (mcg/L) |
| Phase 1b (US Population) | Phase 1b and Phase 2: Mean Concentration of Soluble B-cell Maturation Antigen (BCMA) Levels in Serum After Single Infusion of JNJ-68284528 | Day 1024 | 6.70 Micrograms per liter (mcg/L) |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Mean Concentration of Soluble B-cell Maturation Antigen (BCMA) Levels in Serum After Single Infusion of JNJ-68284528 | Day 352 | 2.01 Micrograms per liter (mcg/L) |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Mean Concentration of Soluble B-cell Maturation Antigen (BCMA) Levels in Serum After Single Infusion of JNJ-68284528 | Day 1024 | 7.05 Micrograms per liter (mcg/L) |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Mean Concentration of Soluble B-cell Maturation Antigen (BCMA) Levels in Serum After Single Infusion of JNJ-68284528 | Day 352 | 5.61 Micrograms per liter (mcg/L) |
Secondary
Phase 1b and Phase 2: Minimal Residual Disease (MRD) Negative Rate
MRD negativity rate was defined as percentage of participants who had negative MRD by bone marrow aspirate at any timepoint after initial dose of JNJ-68284528 and before disease progression or starting subsequent therapy or retreatment with JNJ-68284528. MRD negativity rate was assessed by next-generation sequencing at a threshold of \<10\^5.
Time frame: Pre dose (Day 1) up to 45.2 months
Population: mITT analysis set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level. Here, N (number of participants analyzed) signifies participants with evaluable samples for MRD.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1b (US Population) | Phase 1b and Phase 2: Minimal Residual Disease (MRD) Negative Rate | 100.0 Percentage of participants |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Minimal Residual Disease (MRD) Negative Rate | 89.7 Percentage of participants |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Minimal Residual Disease (MRD) Negative Rate | 75.0 Percentage of participants |
Secondary
Phase 1b and Phase 2: Overall Survival
Overall survival was defined as the time from the date of the initial infusion of JNJ-68284528 to the date of the participant's death.
Time frame: Pre dose (Day 1) up to 45.2 months
Population: mITT analysis set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1b (US Population) | Phase 1b and Phase 2: Overall Survival | NA Months |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Overall Survival | NA Months |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Overall Survival | 27.04 Months |
Secondary
Phase 1b and Phase 2: Percentage of Participants With Positive Antibodies to JNJ-68284528
Percentage of participants with positive antibodies to JNJ-68284528 were reported.
Time frame: Pre dose (Day 1) up to 2 years
Population: All treated analysis set included all participants who received JNJ-68284528 infusion.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1b (US Population) | Phase 1b and Phase 2: Percentage of Participants With Positive Antibodies to JNJ-68284528 | 48.3 Percentage of participants |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Percentage of Participants With Positive Antibodies to JNJ-68284528 | 35.3 Percentage of participants |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Percentage of Participants With Positive Antibodies to JNJ-68284528 | 44.4 Percentage of participants |
Secondary
Phase 1b and Phase 2: Progression-free Survival (PFS)
Progression-free survival was defined as the time from the date of the initial infusion of JNJ-68284528 to the date of first documented disease progression.
Time frame: Pre dose (Day 1) up to 45.2 months
Population: mITT analysis set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1b (US Population) | Phase 1b and Phase 2: Progression-free Survival (PFS) | NA Months |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Progression-free Survival (PFS) | NA Months |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Progression-free Survival (PFS) | NA Months |
Secondary
Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations
Serum systemic cytokine concentrations (Interleukin \[IL\]-6, IL-10, and Interferon Gamma \[IFN-g\]) were reported.
Time frame: Pre-infusion and 2 hours post infusion on Day 1, Days 2, 3, 7, 10, 14, 21, 28, 42, 56, 78, 100
Population: mITT analysis set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level. Here 'n' (number analyzed) signifies participants who were evaluable at specified time points for specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1b (US Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interferon Gamma: Day1 (pre-infusion) | 13.37 nanograms per liter | Standard Error 14.658 |
| Phase 1b (US Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 10: Day 1 (pre-infusion) | 1.19 nanograms per liter | Standard Error 1.17 |
| Phase 1b (US Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 6: Day 1 (Pre-infusion) | 3.66 nanograms per liter | Standard Error 4.28 |
| Phase 1b (US Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 10: Day 100 | 1.45 nanograms per liter | Standard Error 0.881 |
| Phase 1b (US Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 10: Day 1 (2 hours post-infusion) | 1.11 nanograms per liter | Standard Error 0.924 |
| Phase 1b (US Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interferon Gamma: Day 28 | 57.44 nanograms per liter | Standard Error 82.982 |
| Phase 1b (US Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 10: Day 78 | 1.84 nanograms per liter | Standard Error 2.181 |
| Phase 1b (US Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 10: Day 2 | 2.85 nanograms per liter | — |
| Phase 1b (US Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 6: Day 10 | 247.99 nanograms per liter | Standard Error 464.936 |
| Phase 1b (US Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 10: Day 56 | 2.17 nanograms per liter | Standard Error 2.54 |
| Phase 1b (US Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 10: Day 3 | 2.65 nanograms per liter | Standard Error 2.931 |
| Phase 1b (US Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interferon Gamma: Day 78 | 26.19 nanograms per liter | Standard Error 34.12 |
| Phase 1b (US Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 10: Day 42 | 2.36 nanograms per liter | Standard Error 3.27 |
| Phase 1b (US Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 10: Day 7 | 27.95 nanograms per liter | Standard Error 30.506 |
| Phase 1b (US Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interferon Gamma: Day 21 | 108.39 nanograms per liter | Standard Error 113.492 |
| Phase 1b (US Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 10: Day 28 | 2.30 nanograms per liter | Standard Error 1.345 |
| Phase 1b (US Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 10: Day 10 | 36.44 nanograms per liter | Standard Error 56.307 |
| Phase 1b (US Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 6: Day 14 | 42.03 nanograms per liter | Standard Error 63.84 |
| Phase 1b (US Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 10: Day 21 | 5.14 nanograms per liter | Standard Error 5.496 |
| Phase 1b (US Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 10: Day 14 | 20.50 nanograms per liter | Standard Error 90.471 |
| Phase 1b (US Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 6: Day 2 | 4.62 nanograms per liter | — |
| Phase 1b (US Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interferon Gamma: Day 14 | 44.58 nanograms per liter | Standard Error 41.813 |
| Phase 1b (US Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 6: Day 21 | 227.45 nanograms per liter | Standard Error 989.332 |
| Phase 1b (US Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interferon Gamma: Day 100 | 18.51 nanograms per liter | Standard Error 18.052 |
| Phase 1b (US Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interferon Gamma: Day 10 | 4095.68 nanograms per liter | Standard Error 12586.211 |
| Phase 1b (US Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 6: Day 28 | 67.89 nanograms per liter | Standard Error 129.381 |
| Phase 1b (US Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interferon Gamma: Day 56 | 50.58 nanograms per liter | Standard Error 143.096 |
| Phase 1b (US Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interferon Gamma: Day 7 | 284.86 nanograms per liter | Standard Error 397.735 |
| Phase 1b (US Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 6: Day 42 | 56.16 nanograms per liter | Standard Error 153.528 |
| Phase 1b (US Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 6: Day 3 | 7.31 nanograms per liter | Standard Error 12.849 |
| Phase 1b (US Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interferon Gamma: Day 3 | 57.95 nanograms per liter | Standard Error 59.699 |
| Phase 1b (US Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 6: Day 56 | 12.44 nanograms per liter | Standard Error 34.311 |
| Phase 1b (US Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 6: Day 1 (2 hours post-infusion) | 3.59 nanograms per liter | Standard Error 3.892 |
| Phase 1b (US Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interferon Gamma: Day 2 | 50.87 nanograms per liter | — |
| Phase 1b (US Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 6: Day 78 | 56.25 nanograms per liter | Standard Error 164.152 |
| Phase 1b (US Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interferon Gamma: Day 42 | 32.69 nanograms per liter | Standard Error 39.456 |
| Phase 1b (US Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interferon Gamma: Day1 (2 hours post-infusion) | 21.68 nanograms per liter | Standard Error 30.67 |
| Phase 1b (US Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 6: Day 100 | 2.36 nanograms per liter | Standard Error 1.68 |
| Phase 1b (US Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 6: Day 7 | 25.43 nanograms per liter | Standard Error 68.141 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 6: Day 7 | 200.93 nanograms per liter | Standard Error 434.85 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 6: Day 1 (Pre-infusion) | 3.81 nanograms per liter | Standard Error 4.231 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 6: Day 1 (2 hours post-infusion) | 4.05 nanograms per liter | Standard Error 4.158 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 6: Day 2 | 6.47 nanograms per liter | Standard Error 6.783 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 6: Day 3 | 25.57 nanograms per liter | Standard Error 110.008 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interferon Gamma: Day 56 | 1.54 nanograms per liter | Standard Error 0.967 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 6: Day 10 | 227.01 nanograms per liter | Standard Error 405.25 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 6: Day 14 | 110.94 nanograms per liter | Standard Error 512.499 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 6: Day 21 | 69.33 nanograms per liter | Standard Error 291.552 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 6: Day 28 | 110.86 nanograms per liter | Standard Error 593.155 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 6: Day 42 | 141.33 nanograms per liter | Standard Error 908.434 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 6: Day 56 | 113.28 nanograms per liter | Standard Error 749.566 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 6: Day 78 | 137.01 nanograms per liter | Standard Error 753.322 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 6: Day 100 | 239.64 nanograms per liter | Standard Error 1491.202 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 10: Day 1 (pre-infusion) | 1.68 nanograms per liter | Standard Error 2.749 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 10: Day 1 (2 hours post-infusion) | 1.94 nanograms per liter | Standard Error 3.406 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 10: Day 2 | 3.86 nanograms per liter | Standard Error 6.114 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 10: Day 3 | 4.54 nanograms per liter | Standard Error 8.318 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 10: Day 7 | 56.32 nanograms per liter | Standard Error 81.383 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 10: Day 10 | 53.78 nanograms per liter | Standard Error 156.803 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 10: Day 14 | 6.99 nanograms per liter | Standard Error 15.549 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 10: Day 21 | 5.36 nanograms per liter | Standard Error 14.437 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 10: Day 28 | 3.45 nanograms per liter | Standard Error 6.74 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 10: Day 42 | 1.94 nanograms per liter | Standard Error 2.682 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 10: Day 56 | 1.54 nanograms per liter | Standard Error 0.967 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 10: Day 78 | 1.64 nanograms per liter | Standard Error 1.499 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 10: Day 100 | 1.91 nanograms per liter | Standard Error 1.92 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interferon Gamma: Day1 (pre-infusion) | 1.68 nanograms per liter | Standard Error 2.749 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interferon Gamma: Day1 (2 hours post-infusion) | 35.50 nanograms per liter | Standard Error 53.105 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interferon Gamma: Day 2 | 3.86 nanograms per liter | Standard Error 6.114 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interferon Gamma: Day 3 | 4.54 nanograms per liter | Standard Error 8.318 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interferon Gamma: Day 7 | 56.32 nanograms per liter | Standard Error 81.383 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interferon Gamma: Day 10 | 53.78 nanograms per liter | Standard Error 156.803 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interferon Gamma: Day 14 | 6.99 nanograms per liter | Standard Error 15.549 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interferon Gamma: Day 21 | 5.36 nanograms per liter | Standard Error 14.437 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interferon Gamma: Day 28 | 3.45 nanograms per liter | Standard Error 6.74 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interferon Gamma: Day 42 | 1.94 nanograms per liter | Standard Error 2.682 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interferon Gamma: Day 78 | 1.64 nanograms per liter | Standard Error 1.499 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interferon Gamma: Day 100 | 1.91 nanograms per liter | Standard Error 1.92 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 10: Day 100 | 0.72 nanograms per liter | Standard Error 0.272 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 6: Day 100 | 1.45 nanograms per liter | Standard Error 1.123 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interferon Gamma: Day 28 | 44.36 nanograms per liter | Standard Error 45.668 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interferon Gamma: Day1 (pre-infusion) | 25.29 nanograms per liter | Standard Error 15.168 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 6: Day 78 | 3.91 nanograms per liter | Standard Error 6.28 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 6: Day 3 | 3.87 nanograms per liter | Standard Error 4.36 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interferon Gamma: Day1 (2 hours post-infusion) | 25.29 nanograms per liter | Standard Error 15.168 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 6: Day 56 | 8.12 nanograms per liter | Standard Error 8.594 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 6: Day 1 (Pre-infusion) | 1.62 nanograms per liter | Standard Error 1.597 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interferon Gamma: Day 2 | 48.01 nanograms per liter | Standard Error 30.732 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 6: Day 42 | 12.23 nanograms per liter | Standard Error 10.83 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interferon Gamma: Day 42 | 22.76 nanograms per liter | Standard Error 22.233 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interferon Gamma: Day 3 | 44.83 nanograms per liter | Standard Error 48.154 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 6: Day 28 | 18.73 nanograms per liter | Standard Error 26.593 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 6: Day 2 | 2.74 nanograms per liter | Standard Error 2.268 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interferon Gamma: Day 7 | 9043.92 nanograms per liter | Standard Error 26714.417 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 6: Day 21 | 14.25 nanograms per liter | Standard Error 15.439 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interferon Gamma: Day 56 | 19.88 nanograms per liter | Standard Error 32.794 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interferon Gamma: Day 10 | 5351.97 nanograms per liter | Standard Error 11598.493 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 6: Day 14 | 20.62 nanograms per liter | Standard Error 17.898 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 6: Day 1 (2 hours post-infusion) | 1.76 nanograms per liter | Standard Error 1.602 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 10: Day 14 | 6.20 nanograms per liter | Standard Error 6.257 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 10: Day 10 | 102.71 nanograms per liter | Standard Error 184.878 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interferon Gamma: Day 14 | 59.50 nanograms per liter | Standard Error 48.748 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 10: Day 21 | 1.06 nanograms per liter | Standard Error 0.56 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 10: Day 7 | 89.21 nanograms per liter | Standard Error 163.729 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 6: Day 10 | 108.05 nanograms per liter | Standard Error 171.088 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 10: Day 28 | 2.19 nanograms per liter | Standard Error 1.917 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 10: Day 3 | 2.10 nanograms per liter | Standard Error 1.82 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interferon Gamma: Day 100 | 9.04 nanograms per liter | Standard Error 4.958 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 10: Day 42 | 1.52 nanograms per liter | Standard Error 0.853 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 10: Day 2 | 1.90 nanograms per liter | Standard Error 1.695 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interferon Gamma: Day 21 | 28.70 nanograms per liter | Standard Error 22.852 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 10: Day 56 | 2.38 nanograms per liter | Standard Error 2.715 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 10: Day 1 (2 hours post-infusion) | 1.07 nanograms per liter | Standard Error 0.795 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 6: Day 7 | 128.50 nanograms per liter | Standard Error 367.531 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 10: Day 78 | 1.08 nanograms per liter | Standard Error 0.552 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interleukin 10: Day 1 (pre-infusion) | 1.07 nanograms per liter | Standard Error 0.795 |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations | Interferon Gamma: Day 78 | 7.71 nanograms per liter | Standard Error 4.433 |
Secondary
Phase 1b and Phase 2: T Cell Persistence After a Single Infusion of JNJ-68284528
T Cell persistence after a single infusion of JNJ-68284528 was reported. T Cell persistence was defined as actual sampling time of last measurable (non-below quantification limit \[BQL\]) analyte concentration.
Time frame: Pre and post dose on Day 1 and Days 2, 3, 7, 10, 14, 21, 28, 42, 56, 78, 100, then every 4 weeks up to 1 year, and at the time of progressive disease or at study completion for participants without progressive disease (up to approximately 2.5 years)
Population: mITT analysis set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1b (US Population) | Phase 1b and Phase 2: T Cell Persistence After a Single Infusion of JNJ-68284528 | 84.08 Days |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: T Cell Persistence After a Single Infusion of JNJ-68284528 | 100.23 Days |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: T Cell Persistence After a Single Infusion of JNJ-68284528 | 56.81 Days |
Secondary
Phase 1b and Phase 2: Time to First Response
Time to first response was defined as the time between date of the initial infusion of JNJ-68284528 and the first efficacy evaluation that the participant met all criteria for PR or better. IMWG criteria for PR: \>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or \<200 mg per 24 hours, If the serum and urine M-protein are not measurable, a decrease of \>=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, \>=50% reduction in bone marrow PCs is required in place of M-protein, provided baseline bone marrow plasma cell percentage was \>=30%. In addition to the above criteria, if present at baseline, a \>=50% reduction in the size of soft tissue plasmacytomas is also required.
Time frame: Pre dose (Day 1) up to 45.2 months
Population: Analysis population included responders in mITT analysis set. mITT analysis set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1b (US Population) | Phase 1b and Phase 2: Time to First Response | 0.95 Months |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Time to First Response | 0.95 Months |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Time to First Response | 0.92 Months |
Secondary
Phase 1b and Phase 2: Very Good Partial Response (VGPR) or Better Response Rate
VGPR or better response rate was defined as the percentage of participants who achieved VGPR or complete response (CR) (including stringent complete response \[sCR\]) according to the IMWG criteria during or after the study treatment. VGPR: Serum and urine component detectable by immunofixation but not on electrophoresis, or \>= 90% reduction in serum M-protein plus urine M-protein level less than (\<) 100 mg/24 hour; CR: negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and \<5% PCs in bone marrow; sCR: CR in addition to having a normal free light chain (FLC) ratio and an absence of clonal cells in bone marrow by immunohistochemistry, immunofluorescence, 2-4 color flow cytometry.
Time frame: Pre dose (Day 1) up to 45.2 months
Population: mITT analysis Set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1b (US Population) | Phase 1b and Phase 2: Very Good Partial Response (VGPR) or Better Response Rate | 96.6 Percentage of participants |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Very Good Partial Response (VGPR) or Better Response Rate | 94.1 Percentage of participants |
| Phase 2 (Japan Population) | Phase 1b and Phase 2: Very Good Partial Response (VGPR) or Better Response Rate | 100.0 Percentage of participants |
Secondary
Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380
PGIS was a single item to assess severity of pain on a 5-point verbal rating scale ranged from 1 (no pain) to 5 (very severe pain), where 1: none; 2: mild; 3: moderate; 4: severe; 5: very severe. A higher score indicated a more severe pain.
Time frame: Baseline, Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380
Population: mITT analysis Set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure and n (number analyzed) signifies those participants who were evaluable for specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1b (US Population) | Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 | Change at Day 380 | -0.5 Score on a scale | Standard Deviation 0.71 |
| Phase 1b (US Population) | Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 | Change at Day 56 | -0.3 Score on a scale | Standard Deviation 0.79 |
| Phase 1b (US Population) | Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 | Change at Day 78 | -0.3 Score on a scale | Standard Deviation 0.87 |
| Phase 1b (US Population) | Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 | Change at Day 100 | -0.3 Score on a scale | Standard Deviation 0.93 |
| Phase 1b (US Population) | Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 | Change at Day 128 | -0.3 Score on a scale | Standard Deviation 1.06 |
| Phase 1b (US Population) | Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 | Change at Day 156 | -0.4 Score on a scale | Standard Deviation 0.9 |
| Phase 1b (US Population) | Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 | Change at Day 184 | -0.3 Score on a scale | Standard Deviation 1.06 |
| Phase 1b (US Population) | Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 | Change at Day 212 | -0.2 Score on a scale | Standard Deviation 0.97 |
| Phase 1b (US Population) | Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 | Change at Day 240 | -0.3 Score on a scale | Standard Deviation 0.86 |
| Phase 1b (US Population) | Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 | Change at Day 268 | -0.5 Score on a scale | Standard Deviation 0.93 |
| Phase 1b (US Population) | Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 | Change at Day 296 | -0.2 Score on a scale | Standard Deviation 1.2 |
| Phase 1b (US Population) | Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 | Change at Day 324 | -0.6 Score on a scale | Standard Deviation 1.12 |
| Phase 1b (US Population) | Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 | Change at Day 352 | -0.9 Score on a scale | Standard Deviation 1.21 |
| Phase 1b (US Population) | Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 | Change at Day 7 | -0.3 Score on a scale | Standard Deviation 0.96 |
| Phase 1b (US Population) | Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 | Change at Day 28 | -0.3 Score on a scale | Standard Deviation 0.94 |
| Phase 2 (Japan Population) | Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 | Change at Day 7 | 0.3 Score on a scale | Standard Deviation 0.71 |
| Phase 2 (Japan Population) | Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 | Change at Day 296 | 0.0 Score on a scale | Standard Deviation 0 |
| Phase 2 (Japan Population) | Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 | Change at Day 28 | -0.1 Score on a scale | Standard Deviation 0.64 |
| Phase 2 (Japan Population) | Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 | Change at Day 184 | 0.3 Score on a scale | Standard Deviation 0.46 |
| Phase 2 (Japan Population) | Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 | Change at Day 56 | 0.3 Score on a scale | Standard Deviation 0.46 |
| Phase 2 (Japan Population) | Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 | Change at Day 268 | 0.0 Score on a scale | — |
| Phase 2 (Japan Population) | Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 | Change at Day 78 | 0.0 Score on a scale | Standard Deviation 0.53 |
| Phase 2 (Japan Population) | Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 | Change at Day 212 | 0.0 Score on a scale | Standard Deviation 0.63 |
| Phase 2 (Japan Population) | Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 | Change at Day 100 | 0.0 Score on a scale | Standard Deviation 0.53 |
| Phase 2 (Japan Population) | Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 | Change at Day 324 | 0.0 Score on a scale | — |
| Phase 2 (Japan Population) | Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 | Change at Day 128 | 0.0 Score on a scale | Standard Deviation 0.53 |
| Phase 2 (Japan Population) | Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 | Change at Day 240 | 0.0 Score on a scale | Standard Deviation 0 |
| Phase 2 (Japan Population) | Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 | Change at Day 156 | 0.0 Score on a scale | Standard Deviation 0.93 |
Secondary
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324
EORTC QLQ-MY20 scale comprised of 20 questions that addressed four myeloma-specific HRQoL domains: disease symptoms (includes bone aches or pain, back pain, hip pain, arm or shoulder pain, chest pain, and pain increasing with activity), side effects of treatment (includes drowsiness, thirst, feeling ill, dry mouth, hair loss, upset by hair loss, tingling hands or feet, restlessness/agitation, acid indigestion/heartburn, and burning or sore eyes), future perspective (includes worry about death and health in the future, and thinking about illness) and body image. The scale was administered to assess 4 single items: feel restless or agitated, thinking about your illness, worried about dying, worried about health in the future. Scores were averaged and scales were transformed on a 0 to 100 scale. A high score for side effects of treatment represented a high level of symptomatology or problems, whereas a high score for future perspective represented better outcomes.
Time frame: Baseline, Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324
Population: mITT analysis Set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure and n (number analyzed) signifies those participants who were evaluable for specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Restless or agitated: Change at Day 100 | 0.00 Score on a scale | Standard Deviation 17.817 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Restless or agitated: Change at Day 128 | 0.00 Score on a scale | Standard Deviation 25.198 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Restless or agitated: Change at Day 156 | -8.33 Score on a scale | Standard Deviation 15.43 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Worried about health in future: Change at Day 212 | 5.56 Score on a scale | Standard Deviation 13.608 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Worried about health in future: Change at Day 240 | 22.22 Score on a scale | Standard Deviation 19.245 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Worried about dying: Change at Day 156 | 20.83 Score on a scale | Standard Deviation 24.801 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Worried about dying: Change at Day 184 | 29.17 Score on a scale | Standard Deviation 21.362 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Worried about dying: Change at Day 212 | 27.78 Score on a scale | Standard Deviation 25.092 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Worried about dying: Change at Day 240 | 11.11 Score on a scale | Standard Deviation 19.245 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Worried about dying: Change at Day 268 | 16.67 Score on a scale | Standard Deviation 23.57 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Worried about dying: Change at Day 296 | 16.67 Score on a scale | Standard Deviation 23.57 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Worried about dying: Change at Day 324 | 0.00 Score on a scale | — |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Worried about health in future: Change at Day 7 | 0.00 Score on a scale | Standard Deviation 17.817 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Worried about health in future: Change at Day 28 | -4.17 Score on a scale | Standard Deviation 11.785 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Worried about health in future: Change at Day 56 | 4.17 Score on a scale | Standard Deviation 21.362 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Worried about health in future: Change at Day 78 | 4.17 Score on a scale | Standard Deviation 11.785 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Worried about health in future: Change at Day 100 | 0.00 Score on a scale | Standard Deviation 0 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Worried about health in future: Change at Day 128 | 0.00 Score on a scale | Standard Deviation 0 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Worried about health in future: Change at Day 156 | 4.17 Score on a scale | Standard Deviation 11.785 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Worried about health in future: Change at Day 184 | 8.33 Score on a scale | Standard Deviation 15.43 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Worried about health in future: Change at Day 268 | 0.00 Score on a scale | Standard Deviation 0 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Worried about health in future: Change at Day 296 | 0.00 Score on a scale | Standard Deviation 0 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Worried about health in future: Change at Day 324 | 0.00 Score on a scale | — |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Restless or agitated: Change at Day 184 | -4.17 Score on a scale | Standard Deviation 21.362 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Restless or agitated: Change at Day 7 | 12.50 Score on a scale | Standard Deviation 17.252 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Restless or agitated: Change at Day 28 | 8.33 Score on a scale | Standard Deviation 15.43 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Restless or agitated: Change at Day 56 | 0.00 Score on a scale | Standard Deviation 25.198 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Restless or agitated: Change at Day 78 | 0.00 Score on a scale | Standard Deviation 17.817 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Restless or agitated: Change at Day 212 | -5.56 Score on a scale | Standard Deviation 13.608 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Restless or agitated: Change at Day 240 | -11.11 Score on a scale | Standard Deviation 19.245 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Restless or agitated: Change at Day 268 | -16.67 Score on a scale | Standard Deviation 23.57 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Restless or agitated: Change at Day 296 | 0.00 Score on a scale | Standard Deviation 0 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Restless or agitated: Change at Day 324 | -33.33 Score on a scale | — |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Thinking about illness: Change at Day 7 | 4.17 Score on a scale | Standard Deviation 33.034 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Thinking about illness: Change at Day 28 | -4.17 Score on a scale | Standard Deviation 11.785 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Thinking about illness: Change at Day 56 | 8.33 Score on a scale | Standard Deviation 15.43 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Thinking about illness: Change at Day 78 | 4.17 Score on a scale | Standard Deviation 11.785 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Thinking about illness: Change at Day 100 | 8.33 Score on a scale | Standard Deviation 15.43 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Thinking about illness: Change at Day 128 | 8.33 Score on a scale | Standard Deviation 15.43 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Thinking about illness: Change at Day 156 | 12.50 Score on a scale | Standard Deviation 24.801 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Thinking about illness: Change at Day 184 | 12.50 Score on a scale | Standard Deviation 17.252 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Thinking about illness: Change at Day 212 | 22.22 Score on a scale | Standard Deviation 27.217 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Thinking about illness: Change at Day 240 | 0.00 Score on a scale | Standard Deviation 0 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Thinking about illness: Change at Day 268 | 0.00 Score on a scale | Standard Deviation 0 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Thinking about illness: Change at Day 296 | 0.00 Score on a scale | Standard Deviation 0 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Thinking about illness: Change at Day 324 | 0.00 Score on a scale | — |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Worried about dying: Change at Day 7 | 16.67 Score on a scale | Standard Deviation 17.817 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Worried about dying: Change at Day 28 | 8.33 Score on a scale | Standard Deviation 15.43 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Worried about dying: Change at Day 56 | 16.67 Score on a scale | Standard Deviation 25.198 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Worried about dying: Change at Day 78 | 25.00 Score on a scale | Standard Deviation 23.57 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Worried about dying: Change at Day 100 | 25.00 Score on a scale | Standard Deviation 23.57 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Worried about dying: Change at Day 128 | 25.00 Score on a scale | Standard Deviation 23.57 |
Secondary
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324
EORTC QLQ-C30 was a 30 items self-reporting questionnaire, with 1 week recall period, resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 Global Health Status scale (GHS), 3 symptom scales (fatigue, nausea and vomiting, and pain) and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Questionnaire includes 28 items with 4-point Likert type responses from 1-not at all to 4-very much to assess functioning and symptoms;2 items with 7-point Likert scales (1= poor and 7= excellent) for global health and overall health related QoL. Scores are transformed to 0 to 100 scale, with higher scores representing better GHS, better functioning, and more symptoms. Negative change from baseline values shows deterioration in quality of life or functioning and reduction in symptom and positive values indicate improvement and worsening of symptoms.
Time frame: Baseline, Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324
Population: mITT analysis Set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure and n (number analyzed) signifies those participants who were evaluable for specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Physical functional scales: Change at Day 7 | -2.50 Score on a scale | Standard Deviation 12.312 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Physical functional scales: Change at Day 28 | -4.17 Score on a scale | Standard Deviation 10.04 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Physical functional scales: Change at Day 56 | -1.67 Score on a scale | Standard Deviation 6.901 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Physical functional scales: Change at Day 78 | 0.00 Score on a scale | Standard Deviation 3.563 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Physical functional scales: Change at Day 100 | -1.67 Score on a scale | Standard Deviation 5.909 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Physical functional scales: Change at Day 128 | -0.83 Score on a scale | Standard Deviation 8.309 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Physical functional scales: Change at Day 156 | 0.83 Score on a scale | Standard Deviation 6.607 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Physical functional scales: Change at Day 184 | 4.17 Score on a scale | Standard Deviation 4.96 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Physical functional scales: Change at Day 212 | 4.44 Score on a scale | Standard Deviation 5.443 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Physical functional scales: Change at Day 240 | 4.44 Score on a scale | Standard Deviation 7.698 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Physical functional scales: Change at Day 268 | -3.33 Score on a scale | Standard Deviation 4.714 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Physical functional scales: Change at Day 296 | 0.00 Score on a scale | Standard Deviation 0 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Physical functional scales: Change at Day 324 | 0.00 Score on a scale | — |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Role functional scales: Change at Day 7 | -10.42 Score on a scale | Standard Deviation 15.269 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Role functional scales: Change at Day 28 | -8.33 Score on a scale | Standard Deviation 17.817 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Role functional scales: Change at Day 56 | -12.50 Score on a scale | Standard Deviation 17.252 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Role functional scales: Change at Day 78 | -6.25 Score on a scale | Standard Deviation 26.633 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Role functional scales: Change at Day 100 | -6.25 Score on a scale | Standard Deviation 15.269 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Role functional scales: Change at Day 128 | -16.67 Score on a scale | Standard Deviation 26.726 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Role functional scales: Change at Day 156 | -10.42 Score on a scale | Standard Deviation 26.633 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Role functional scales: Change at Day 184 | -10.42 Score on a scale | Standard Deviation 29.463 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Role functional scales: Change at Day 212 | -8.33 Score on a scale | Standard Deviation 20.412 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Role functional scales: Change at Day 240 | -11.11 Score on a scale | Standard Deviation 19.245 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Role functional scales: Change at Day 268 | -8.33 Score on a scale | Standard Deviation 11.785 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Role functional scales: Change at Day 296 | -16.67 Score on a scale | Standard Deviation 23.57 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Role functional scales: Change at Day 324 | -16.67 Score on a scale | — |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Emotional functional scales: Change at Day 7 | 2.08 Score on a scale | Standard Deviation 9.708 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Emotional functional scales: Change at Day 28 | 1.04 Score on a scale | Standard Deviation 8.259 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Emotional functional scales: Change at Day 56 | 6.25 Score on a scale | Standard Deviation 8.626 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Emotional functional scales: Change at Day 78 | 4.17 Score on a scale | Standard Deviation 9.96 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Emotional functional scales: Change at Day 100 | 5.21 Score on a scale | Standard Deviation 8.839 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Emotional functional scales: Change at Day 128 | 3.13 Score on a scale | Standard Deviation 11.732 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Emotional functional scales: Change at Day 156 | 5.21 Score on a scale | Standard Deviation 9.898 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Emotional functional scales: Change at Day 184 | 9.38 Score on a scale | Standard Deviation 6.954 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Emotional functional scales: Change at Day 212 | 2.78 Score on a scale | Standard Deviation 6.804 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Emotional functional scales: Change at Day 240 | 11.11 Score on a scale | Standard Deviation 9.623 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Emotional functional scales: Change at Day 268 | 8.33 Score on a scale | Standard Deviation 11.785 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Emotional functional scales: Change at Day 296 | -4.17 Score on a scale | Standard Deviation 5.893 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Emotional functional scales: Change at Day 324 | 16.67 Score on a scale | — |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Cognitive functional scales: Change at Day 7 | -4.17 Score on a scale | Standard Deviation 11.785 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Cognitive functional scales: Change at Day 28 | 2.08 Score on a scale | Standard Deviation 5.893 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Cognitive functional scales: Change at Day 56 | -4.17 Score on a scale | Standard Deviation 14.773 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Cognitive functional scales: Change at Day 78 | 0.00 Score on a scale | Standard Deviation 12.599 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Cognitive functional scales: Change at Day 100 | -2.08 Score on a scale | Standard Deviation 10.681 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Cognitive functional scales: Change at Day 128 | -4.17 Score on a scale | Standard Deviation 11.785 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Cognitive functional scales: Change at Day 156 | 0.00 Score on a scale | Standard Deviation 15.43 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Cognitive functional scales: Change at Day 184 | 2.08 Score on a scale | Standard Deviation 13.909 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Cognitive functional scales: Change at Day 212 | 0.00 Score on a scale | Standard Deviation 14.907 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Cognitive functional scales: Change at Day 240 | 11.11 Score on a scale | Standard Deviation 9.623 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Cognitive functional scales: Change at Day 268 | 8.33 Score on a scale | Standard Deviation 11.785 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Cognitive functional scales: Change at Day 296 | -8.33 Score on a scale | Standard Deviation 11.785 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Cognitive functional scales: Change at Day 324 | 0.00 Score on a scale | — |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Social functional scales: Change at Day 7 | -2.08 Score on a scale | Standard Deviation 20.774 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Social functional scales: Change at Day 28 | 2.08 Score on a scale | Standard Deviation 5.893 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Social functional scales: Change at Day 56 | 4.17 Score on a scale | Standard Deviation 7.715 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Social functional scales: Change at Day 78 | -2.08 Score on a scale | Standard Deviation 16.517 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Social functional scales: Change at Day 100 | 4.17 Score on a scale | Standard Deviation 19.416 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Social functional scales: Change at Day 128 | 0.00 Score on a scale | Standard Deviation 8.909 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Social functional scales: Change at Day 156 | 0.00 Score on a scale | Standard Deviation 15.43 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Social functional scales: Change at Day 184 | 6.25 Score on a scale | Standard Deviation 12.4 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Social functional scales: Change at Day 212 | 0.00 Score on a scale | Standard Deviation 10.541 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Social functional scales: Change at Day 240 | 11.11 Score on a scale | Standard Deviation 9.623 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Social functional scales: Change at Day 268 | 16.67 Score on a scale | Standard Deviation 23.57 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Social functional scales: Change at Day 296 | 0.00 Score on a scale | Standard Deviation 0 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Social functional scales: Change at Day 324 | 33.33 Score on a scale | — |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Global health status scale: Change at Day 7 | -8.33 Score on a scale | Standard Deviation 15.43 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Global health status scale: Change at Day 28 | -13.54 Score on a scale | Standard Deviation 30.19 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Global health status scale: Change at Day 56 | -4.17 Score on a scale | Standard Deviation 17.817 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Global health status scale: Change at Day 78 | -6.25 Score on a scale | Standard Deviation 8.626 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Global health status scale: Change at Day 100 | -2.08 Score on a scale | Standard Deviation 13.176 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Global health status scale: Change at Day 128 | -3.13 Score on a scale | Standard Deviation 17.783 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Global health status scale: Change at Day 156 | -3.13 Score on a scale | Standard Deviation 14.042 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Global health status scale: Change at Day 184 | -5.21 Score on a scale | Standard Deviation 13.317 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Global health status scale: Change at Day 212 | -2.78 Score on a scale | Standard Deviation 6.804 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Global health status scale: Change at Day 240 | 5.56 Score on a scale | Standard Deviation 12.729 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Global health status scale: Change at Day 268 | 12.50 Score on a scale | Standard Deviation 5.893 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Global health status scale: Change at Day 296 | -4.17 Score on a scale | Standard Deviation 17.678 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Global health status scale: Change at Day 324 | 16.67 Score on a scale | — |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Pain symptom scales: Change at Day 7 | 20.83 Score on a scale | Standard Deviation 30.538 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Pain symptom scales: Change at Day 28 | -2.08 Score on a scale | Standard Deviation 10.681 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Pain symptom scales: Change at Day 56 | 8.33 Score on a scale | Standard Deviation 17.817 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Pain symptom scales: Change at Day 78 | 4.17 Score on a scale | Standard Deviation 14.773 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Pain symptom scales: Change at Day 100 | 2.08 Score on a scale | Standard Deviation 10.681 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Pain symptom scales: Change at Day 128 | 4.17 Score on a scale | Standard Deviation 19.416 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Pain symptom scales: Change at Day 156 | 0.00 Score on a scale | Standard Deviation 12.599 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Pain symptom scales: Change at Day 184 | 2.08 Score on a scale | Standard Deviation 5.893 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Pain symptom scales: Change at Day 212 | -2.78 Score on a scale | Standard Deviation 12.546 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Pain symptom scales: Change at Day 240 | -5.56 Score on a scale | Standard Deviation 9.623 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Pain symptom scales: Change at Day 268 | -8.33 Score on a scale | Standard Deviation 11.785 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Pain symptom scales: Change at Day 296 | 0.00 Score on a scale | Standard Deviation 23.57 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Pain symptom scales: Change at Day 324 | 0.00 Score on a scale | — |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Fatigue symptom scales: Change at Day 7 | 4.17 Score on a scale | Standard Deviation 30.825 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Fatigue symptom scales: Change at Day 28 | 1.39 Score on a scale | Standard Deviation 13.849 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Fatigue symptom scales: Change at Day 56 | 6.94 Score on a scale | Standard Deviation 10.179 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Fatigue symptom scales: Change at Day 78 | 6.94 Score on a scale | Standard Deviation 13.197 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Fatigue symptom scales: Change at Day 100 | 2.78 Score on a scale | Standard Deviation 9.849 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Fatigue symptom scales: Change at Day 128 | 6.94 Score on a scale | Standard Deviation 19.642 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Fatigue symptom scales: Change at Day 156 | 2.78 Score on a scale | Standard Deviation 7.857 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Fatigue symptom scales: Change at Day 184 | 0.00 Score on a scale | Standard Deviation 5.939 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Fatigue symptom scales: Change at Day 212 | -5.56 Score on a scale | Standard Deviation 9.296 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Fatigue symptom scales: Change at Day 240 | 3.70 Score on a scale | Standard Deviation 35.717 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Fatigue symptom scales: Change at Day 268 | 0.00 Score on a scale | Standard Deviation 15.713 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Fatigue symptom scales: Change at Day 296 | 16.67 Score on a scale | Standard Deviation 23.57 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Fatigue symptom scales: Change at Day 324 | 11.11 Score on a scale | — |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Nausea/vomiting symptom scales: Change at Day 7 | 14.58 Score on a scale | Standard Deviation 18.767 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Nausea/vomiting symptom scales: Change at Day 28 | 2.08 Score on a scale | Standard Deviation 5.893 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Nausea/vomiting symptom scales: Change at Day 56 | 2.08 Score on a scale | Standard Deviation 5.893 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Nausea/vomiting symptom scales: Change at Day 78 | 2.08 Score on a scale | Standard Deviation 5.893 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Nausea/vomiting symptom scales: Change at Day 100 | 0.00 Score on a scale | Standard Deviation 0 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Nausea/vomiting symptom scales: Change at Day 128 | 0.00 Score on a scale | Standard Deviation 0 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Nausea/vomiting symptom scales: Change at Day 156 | 0.00 Score on a scale | Standard Deviation 0 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Nausea/vomiting symptom scales: Change at Day 184 | 0.00 Score on a scale | Standard Deviation 0 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Nausea/vomiting symptom scales: Change at Day 212 | 0.00 Score on a scale | Standard Deviation 0 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Nausea/vomiting symptom scales: Change at Day 240 | 0.00 Score on a scale | Standard Deviation 0 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Nausea/vomiting symptom scales: Change at Day 268 | 0.00 Score on a scale | Standard Deviation 0 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Nausea/vomiting symptom scales: Change at Day 296 | 0.00 Score on a scale | Standard Deviation 47.14 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Nausea/vomiting symptom scales: Change at Day 324 | 0.00 Score on a scale | — |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Dyspnea: Change at Day 7 | 4.17 Score on a scale | Standard Deviation 45.207 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Dyspnea: Change at Day 28 | -12.50 Score on a scale | Standard Deviation 24.801 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Dyspnea: Change at Day 56 | -4.17 Score on a scale | Standard Deviation 21.362 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Dyspnea: Change at Day 78 | 8.33 Score on a scale | Standard Deviation 29.547 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Dyspnea: Change at Day 100 | 0.00 Score on a scale | Standard Deviation 17.817 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Dyspnea: Change at Day 128 | -8.33 Score on a scale | Standard Deviation 15.43 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Dyspnea: Change at Day 156 | -12.50 Score on a scale | Standard Deviation 24.801 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Dyspnea: Change at Day 184 | -12.50 Score on a scale | Standard Deviation 24.801 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Dyspnea: Change at Day 212 | -16.67 Score on a scale | Standard Deviation 27.889 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Dyspnea: Change at Day 240 | -11.11 Score on a scale | Standard Deviation 38.49 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Dyspnea: Change at Day 268 | 0.00 Score on a scale | Standard Deviation 47.14 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Dyspnea: Change at Day 296 | 0.00 Score on a scale | Standard Deviation 47.14 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Dyspnea: Change at Day 324 | 33.33 Score on a scale | — |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Insomnia: Change at Day 7 | 8.33 Score on a scale | Standard Deviation 23.57 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Insomnia: Change at Day 28 | -4.17 Score on a scale | Standard Deviation 21.362 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Insomnia: Change at Day 56 | -4.17 Score on a scale | Standard Deviation 21.362 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Insomnia: Change at Day 78 | 0.00 Score on a scale | Standard Deviation 17.817 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Insomnia: Change at Day 100 | 4.17 Score on a scale | Standard Deviation 11.785 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Insomnia: Change at Day 128 | -4.17 Score on a scale | Standard Deviation 21.362 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Insomnia: Change at Day 156 | -4.17 Score on a scale | Standard Deviation 21.362 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Insomnia: Change at Day 184 | -8.33 Score on a scale | Standard Deviation 15.43 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Insomnia: Change at Day 212 | 0.00 Score on a scale | Standard Deviation 21.082 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Insomnia: Change at Day 240 | -11.11 Score on a scale | Standard Deviation 19.245 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Insomnia: Change at Day 268 | -16.67 Score on a scale | Standard Deviation 23.57 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Insomnia: Change at Day 296 | 16.67 Score on a scale | Standard Deviation 23.57 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Insomnia: Change at Day 324 | 0.00 Score on a scale | — |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Appetite loss: Change at Day 7 | 20.83 Score on a scale | Standard Deviation 24.801 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Appetite loss: Change at Day 28 | 16.67 Score on a scale | Standard Deviation 17.817 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Appetite loss: Change at Day 56 | 4.17 Score on a scale | Standard Deviation 11.785 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Appetite loss: Change at Day 78 | 8.33 Score on a scale | Standard Deviation 15.43 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Appetite loss: Change at Day 100 | 4.17 Score on a scale | Standard Deviation 11.785 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Appetite loss: Change at Day 128 | 16.67 Score on a scale | Standard Deviation 25.198 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Appetite loss: Change at Day 156 | 4.17 Score on a scale | Standard Deviation 11.785 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Appetite loss: Change at Day 184 | 4.17 Score on a scale | Standard Deviation 11.785 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Appetite loss: Change at Day 212 | 0.00 Score on a scale | Standard Deviation 0 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Appetite loss: Change at Day 240 | 0.00 Score on a scale | Standard Deviation 0 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Appetite loss: Change at Day 268 | 0.00 Score on a scale | Standard Deviation 0 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Appetite loss: Change at Day 296 | 16.67 Score on a scale | Standard Deviation 23.57 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Appetite loss: Change at Day 324 | -33.33 Score on a scale | — |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Constipation: Change at Day 7 | 0.00 Score on a scale | Standard Deviation 17.817 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Constipation: Change at Day 28 | -4.17 Score on a scale | Standard Deviation 11.785 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Constipation: Change at Day 56 | 0.00 Score on a scale | Standard Deviation 17.817 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Constipation: Change at Day 78 | -4.17 Score on a scale | Standard Deviation 11.785 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Constipation: Change at Day 100 | 0.00 Score on a scale | Standard Deviation 0 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Constipation: Change at Day 128 | -4.17 Score on a scale | Standard Deviation 11.785 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Constipation: Change at Day 156 | -4.17 Score on a scale | Standard Deviation 11.785 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Constipation: Change at Day 184 | -4.17 Score on a scale | Standard Deviation 11.785 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Constipation: Change at Day 212 | 0.00 Score on a scale | Standard Deviation 0 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Constipation: Change at Day 240 | 0.00 Score on a scale | Standard Deviation 0 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Constipation: Change at Day 268 | 16.67 Score on a scale | Standard Deviation 23.57 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Constipation: Change at Day 296 | 50.00 Score on a scale | Standard Deviation 70.711 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Constipation: Change at Day 324 | 0.00 Score on a scale | — |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Diarrhea: Change at Day 7 | 8.33 Score on a scale | Standard Deviation 23.57 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Diarrhea: Change at Day 28 | 0.00 Score on a scale | Standard Deviation 25.198 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Diarrhea: Change at Day 56 | -12.50 Score on a scale | Standard Deviation 24.801 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Diarrhea: Change at Day 78 | -12.50 Score on a scale | Standard Deviation 24.801 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Diarrhea: Change at Day 100 | 0.00 Score on a scale | Standard Deviation 35.635 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Diarrhea: Change at Day 128 | -8.33 Score on a scale | Standard Deviation 23.57 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Diarrhea: Change at Day 156 | -8.33 Score on a scale | Standard Deviation 23.57 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Diarrhea: Change at Day 184 | -8.33 Score on a scale | Standard Deviation 15.43 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Diarrhea: Change at Day 212 | 0.00 Score on a scale | Standard Deviation 21.082 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Diarrhea: Change at Day 240 | 11.11 Score on a scale | Standard Deviation 19.245 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Diarrhea: Change at Day 268 | 33.33 Score on a scale | Standard Deviation 0 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Diarrhea: Change at Day 296 | -16.67 Score on a scale | Standard Deviation 23.57 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Diarrhea: Change at Day 324 | 33.33 Score on a scale | — |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Financial difficulties: Change at Day 7 | -4.17 Score on a scale | Standard Deviation 21.362 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Financial difficulties: Change at Day 28 | -4.17 Score on a scale | Standard Deviation 11.785 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Financial difficulties: Change at Day 56 | -12.50 Score on a scale | Standard Deviation 17.252 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Financial difficulties: Change at Day 78 | -8.33 Score on a scale | Standard Deviation 23.57 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Financial difficulties: Change at Day 100 | -12.50 Score on a scale | Standard Deviation 17.252 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Financial difficulties: Change at Day 128 | 0.00 Score on a scale | Standard Deviation 30.861 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Financial difficulties: Change at Day 156 | -12.50 Score on a scale | Standard Deviation 17.252 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Financial difficulties: Change at Day 184 | -12.50 Score on a scale | Standard Deviation 17.252 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Financial difficulties: Change at Day 212 | -11.11 Score on a scale | Standard Deviation 27.217 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Financial difficulties: Change at Day 240 | 0.00 Score on a scale | Standard Deviation 33.333 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Financial difficulties: Change at Day 268 | -16.67 Score on a scale | Standard Deviation 23.57 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Financial difficulties: Change at Day 296 | -16.67 Score on a scale | Standard Deviation 23.57 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Financial difficulties: Change at Day 324 | -33.33 Score on a scale | — |
Secondary
Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324
EQ-5D-5L was a 5-item questionnaire consisted of 2 components: a health state profile/a single utility index value and an optional VAS. EQ-5D health state profile/a single utility index value had 5 dimensions including mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 5 response levels: 1 =no problems, 2 =slight problems, 3 =moderate problems, 4 =severe problems and 5 =extreme problems. The scores for the 5 dimensions were used to compute a single utility score ranging from 0 to 1 representing the general health status of the individual. Higher score indicated better health status. EQ-5D VAS was used to record participant's rating for his/her health today and ranging from 0 to 100, where 0 = worst imaginable health state and 100 = best imaginable health state.
Time frame: Baseline, Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324
Population: mITT analysis Set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure and n (number analyzed) signifies those participants who were evaluable for specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Change at Day 7 | -0.05 Score on a scale | Standard Deviation 0.149 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Change at Day 28 | -0.06 Score on a scale | Standard Deviation 0.185 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Change at Day 56 | -0.03 Score on a scale | Standard Deviation 0.057 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Change at Day 78 | 0.01 Score on a scale | Standard Deviation 0.098 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Change at Day 100 | -0.04 Score on a scale | Standard Deviation 0.075 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Change at Day 128 | 0.00 Score on a scale | Standard Deviation 0.063 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Change at Day 156 | -0.02 Score on a scale | Standard Deviation 0.053 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Change at Day 184 | -0.01 Score on a scale | Standard Deviation 0.079 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Change at Day 212 | 0.04 Score on a scale | Standard Deviation 0.109 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Change at Day 240 | 0.05 Score on a scale | Standard Deviation 0.079 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Change at Day 268 | 0.07 Score on a scale | Standard Deviation 0.096 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Change at Day 296 | 0.04 Score on a scale | Standard Deviation 0.061 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Change at Day 324 | 0.14 Score on a scale | — |
Secondary
Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324
EQ-5D-5L was a 5-item questionnaire consisted of 2 components: a health state profile/a single utility index value and an optional VAS. EQ-5D health state profile/a single utility index value had 5 dimensions including mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 5 response levels: 1 =no problems, 2 =slight problems, 3 =moderate problems, 4 =severe problems and 5 =extreme problems. The scores for the 5 dimensions were used to compute a single utility score ranging from 0 to 1 representing the general health status of the individual. Higher score indicated better health status. EQ-5D VAS was used to record participant's rating for his/her health today and ranging from 0 to 100, where 0 = worst imaginable health state and 100 = best imaginable health state.
Time frame: Baseline, Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324
Population: mITT analysis Set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure and n (number analyzed) signifies those participants who were evaluable for specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Change at Day 212 | 2.50 Score on a scale | Standard Deviation 9.586 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Change at Day 7 | -13.75 Score on a scale | Standard Deviation 17.269 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Change at Day 28 | -0.75 Score on a scale | Standard Deviation 8.795 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Change at Day 56 | -4.50 Score on a scale | Standard Deviation 6.803 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Change at Day 78 | -3.00 Score on a scale | Standard Deviation 9.914 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Change at Day 100 | -1.88 Score on a scale | Standard Deviation 7.53 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Change at Day 128 | 0.00 Score on a scale | Standard Deviation 11.019 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Change at Day 156 | 0.00 Score on a scale | Standard Deviation 8.452 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Change at Day 184 | -0.25 Score on a scale | Standard Deviation 7.005 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Change at Day 240 | 0.00 Score on a scale | Standard Deviation 8.66 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Change at Day 268 | -2.50 Score on a scale | Standard Deviation 10.607 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Change at Day 296 | -12.50 Score on a scale | Standard Deviation 24.749 |
| Phase 1b (US Population) | Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 | Change at Day 324 | -10.00 Score on a scale | — |
Secondary
Phase 2: Number of Participants With Adverse Events (AEs) as Per Severity
An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Severity was graded according to the NCI-CTCAE version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Time frame: Day 1 up to 45.2 months
Population: All treated analysis set included all participants who received JNJ-68284528 infusion.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1b (US Population) | Phase 2: Number of Participants With Adverse Events (AEs) as Per Severity | Grade 2 | 0 Participants |
| Phase 1b (US Population) | Phase 2: Number of Participants With Adverse Events (AEs) as Per Severity | Grade 4 | 58 Participants |
| Phase 1b (US Population) | Phase 2: Number of Participants With Adverse Events (AEs) as Per Severity | Grade 3 | 5 Participants |
| Phase 1b (US Population) | Phase 2: Number of Participants With Adverse Events (AEs) as Per Severity | Grade 5 | 5 Participants |
| Phase 1b (US Population) | Phase 2: Number of Participants With Adverse Events (AEs) as Per Severity | Grade 1 | 0 Participants |
| Phase 2 (Japan Population) | Phase 2: Number of Participants With Adverse Events (AEs) as Per Severity | Grade 5 | 0 Participants |
| Phase 2 (Japan Population) | Phase 2: Number of Participants With Adverse Events (AEs) as Per Severity | Grade 1 | 0 Participants |
| Phase 2 (Japan Population) | Phase 2: Number of Participants With Adverse Events (AEs) as Per Severity | Grade 2 | 1 Participants |
| Phase 2 (Japan Population) | Phase 2: Number of Participants With Adverse Events (AEs) as Per Severity | Grade 3 | 0 Participants |
| Phase 2 (Japan Population) | Phase 2: Number of Participants With Adverse Events (AEs) as Per Severity | Grade 4 | 8 Participants |
Secondary
Phase 2: Patient Global Impression of Change (PGIC) Score at Days 28, 56, 78, 100
PGIC was a single item to assess the participant's perception in change of their overall health status using a 7-point verbal rating scale ranging from 1(a lot better now) to 7 (a lot verse now), where 1: a lot better now; 2: moderately better now; 3: a little better now; 4: neither better nor worse; 5: a little worse now; 6: moderately worse now; 7: a lot worse now. Higher score indicated worse health status.
Time frame: Days 28, 56, 78, 100
Population: mITT analysis set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure and n (number analyzed) signifies those participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1b (US Population) | Phase 2: Patient Global Impression of Change (PGIC) Score at Days 28, 56, 78, 100 | Change at Day 28 | 2.7 Score on a scale | Standard Deviation 1.63 |
| Phase 1b (US Population) | Phase 2: Patient Global Impression of Change (PGIC) Score at Days 28, 56, 78, 100 | Change at Day 56 | 2.5 Score on a scale | Standard Deviation 1.66 |
| Phase 1b (US Population) | Phase 2: Patient Global Impression of Change (PGIC) Score at Days 28, 56, 78, 100 | Change at Day 78 | 2.2 Score on a scale | Standard Deviation 1.51 |
| Phase 1b (US Population) | Phase 2: Patient Global Impression of Change (PGIC) Score at Days 28, 56, 78, 100 | Change at Day 100 | 2.0 Score on a scale | Standard Deviation 1.43 |
| Phase 2 (Japan Population) | Phase 2: Patient Global Impression of Change (PGIC) Score at Days 28, 56, 78, 100 | Change at Day 100 | 2.4 Score on a scale | Standard Deviation 0.79 |
| Phase 2 (Japan Population) | Phase 2: Patient Global Impression of Change (PGIC) Score at Days 28, 56, 78, 100 | Change at Day 28 | 2.8 Score on a scale | Standard Deviation 0.89 |
| Phase 2 (Japan Population) | Phase 2: Patient Global Impression of Change (PGIC) Score at Days 28, 56, 78, 100 | Change at Day 78 | 2.5 Score on a scale | Standard Deviation 0.93 |
| Phase 2 (Japan Population) | Phase 2: Patient Global Impression of Change (PGIC) Score at Days 28, 56, 78, 100 | Change at Day 56 | 2.9 Score on a scale | Standard Deviation 1.25 |
Secondary
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380
EORTC QLQ-MY20 scale comprised of 20 questions that addressed four myeloma-specific HRQoL domains: disease symptoms (includes bone aches or pain, back pain, hip pain, arm or shoulder pain, chest pain, and pain increasing with activity), side effects of treatment (includes drowsiness, thirst, feeling ill, dry mouth, hair loss, upset by hair loss, tingling hands or feet, restlessness/agitation, acid indigestion/heartburn, and burning or sore eyes), future perspective (includes worry about death and health in the future, and thinking about illness) and body image. The scale was administered to assess 4 single items: feel restless or agitated, thinking about your illness, worried about dying, worried about health in the future. Scores were averaged and scales were transformed on a 0 to 100 scale. A high score for side effects of treatment represented a high level of symptomatology or problems, whereas a high score for future perspective represented better outcomes.
Time frame: Baseline, Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380
Population: mITT analysis Set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure and n (number analyzed) signifies those participants who were evaluable for specified time points.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Restless or agitated: Change at Day 7 | 5.7 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Restless or agitated: Change at Day 28 | -5.5 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Restless or agitated: Change at Day 56 | 1.6 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Restless or agitated: Change at Day 78 | -2.7 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Restless or agitated: Change at Day 100 | -3.3 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Restless or agitated: Change at Day 128 | -3.9 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Restless or agitated: Change at Day 156 | 0.9 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Restless or agitated: Change at Day 184 | -3.6 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Restless or agitated: Change at Day 212 | -3.9 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Restless or agitated: Change at Day 240 | -12.7 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Restless or agitated: Change at Day 268 | -1.7 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Restless or agitated: Change at Day 296 | -7.8 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Restless or agitated: Change at Day 324 | -11.5 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Restless or agitated: Change at Day 352 | 1.1 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Restless or agitated: Change at Day 380 | -23.2 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Thinking about illness: Change at Day 7 | 7.8 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Thinking about illness: Change at Day 28 | 15 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Thinking about illness: Change at Day 56 | 17.1 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Thinking about illness: Change at Day 78 | 23.1 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Thinking about illness: Change at Day 100 | 25.7 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Thinking about illness: Change at Day 128 | 27.6 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Thinking about illness: Change at Day 156 | 29.9 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Thinking about illness: Change at Day 184 | 27.9 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Thinking about illness: Change at Day 212 | 34.7 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Thinking about illness: Change at Day 240 | 32.1 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Thinking about illness: Change at Day 268 | 34.9 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Thinking about illness: Change at Day 296 | 32.6 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Thinking about illness: Change at Day 324 | 35.1 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Thinking about illness: Change at Day 352 | 33.5 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Thinking about illness: Change at Day 380 | 34.3 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Worried about dying: Change at Day 7 | 13.2 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Worried about dying: Change at Day 28 | 18.2 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Worried about dying: Change at Day 56 | 16.8 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Worried about dying: Change at Day 78 | 18.3 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Worried about dying: Change at Day 100 | 18.9 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Worried about dying: Change at Day 128 | 16.8 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Worried about dying: Change at Day 156 | 14.9 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Worried about dying: Change at Day 184 | 15.8 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Worried about dying: Change at Day 212 | 13.3 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Worried about dying: Change at Day 240 | 14.7 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Worried about dying: Change at Day 268 | 10 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Worried about dying: Change at Day 296 | 16.3 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Worried about dying: Change at Day 324 | 17.6 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Worried about dying: Change at Day 352 | 14.9 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Worried about dying: Change at Day 380 | 27.1 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Worried about health in future: Change at Day 7 | 8.2 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Worried about health in future: Change at Day 28 | 18.2 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Worried about health in future: Change at Day 56 | 15.5 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Worried about health in future: Change at Day 78 | 19.7 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Worried about health in future: Change at Day 100 | 14.3 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Worried about health in future: Change at Day 128 | 20.4 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Worried about health in future: Change at Day 156 | 18.9 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Worried about health in future: Change at Day 184 | 19 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Worried about health in future: Change at Day 212 | 19.9 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Worried about health in future: Change at Day 240 | 19.7 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Worried about health in future: Change at Day 268 | 17.1 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Worried about health in future: Change at Day 296 | 24.2 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Worried about health in future: Change at Day 324 | 20.2 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Worried about health in future: Change at Day 352 | 25.1 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Worried about health in future: Change at Day 380 | 7.7 Score on a scale |
Secondary
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380
EORTC QLQ-C30 was a 30 items self-reporting questionnaire, with 1 week recall period, resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 Global Health Status scale (GHS), 3 symptom scales (fatigue, nausea and vomiting, and pain) and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Questionnaire includes 28 items with 4-point Likert type responses from 1-not at all to 4-very much to assess functioning and symptoms;2 items with 7-point Likert scales (1= poor and 7= excellent) for global health and overall health related QoL. Scores are transformed to 0 to 100 scale, with higher scores representing better GHS, better functioning, and more symptoms. Negative change from baseline values shows deterioration in quality of life or functioning and reduction in symptom and positive values indicate improvement and worsening of symptoms.
Time frame: Baseline, Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380
Population: mITT analysis Set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure and n (number analyzed) signifies those participants who were evaluable for specified time points.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Physical functional scales: Change at Day 7 | -14.4 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Physical functional scales: Change at Day 28 | -7.2 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Physical functional scales: Change at Day 56 | -5.2 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Physical functional scales: Change at Day 78 | -2.3 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Physical functional scales: Change at Day 100 | -4.8 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Physical functional scales: Change at Day 128 | 0 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Physical functional scales: Change at Day 156 | -3.9 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Physical functional scales: Change at Day 184 | -0.6 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Physical functional scales: Change at Day 212 | 2.2 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Physical functional scales: Change at Day 240 | 1.5 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Physical functional scales: Change at Day 268 | 2.4 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Physical functional scales: Change at Day 296 | 3.1 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Physical functional scales: Change at Day 324 | 6.6 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Physical functional scales: Change at Day 352 | 6.4 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Physical functional scales: Change at Day 380 | -5.5 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Role functional scales: Change at Day 7 | -24.2 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Role functional scales: Change at Day 28 | -12.3 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Role functional scales: Change at Day 56 | -8.5 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Role functional scales: Change at Day 78 | -3.5 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Role functional scales: Change at Day 100 | -3 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Role functional scales: Change at Day 128 | 0.3 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Role functional scales: Change at Day 156 | -3.7 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Role functional scales: Change at Day 184 | 1.1 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Role functional scales: Change at Day 212 | 0.3 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Role functional scales: Change at Day 240 | 1.3 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Role functional scales: Change at Day 268 | 5.5 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Role functional scales: Change at Day 296 | 4.2 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Role functional scales: Change at Day 324 | 7.3 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Role functional scales: Change at Day 352 | 8.3 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Role functional scales: Change at Day 380 | -3.5 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Emotional functional scales: Change at Day 7 | 3.1 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Emotional functional scales: Change at Day 28 | 6.1 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Emotional functional scales: Change at Day 56 | 5.6 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Emotional functional scales: Change at Day 78 | 5.7 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Emotional functional scales: Change at Day 100 | 4.8 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Emotional functional scales: Change at Day 128 | 6.3 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Emotional functional scales: Change at Day 156 | 1.7 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Emotional functional scales: Change at Day 184 | 5.7 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Emotional functional scales: Change at Day 212 | 6.3 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Emotional functional scales: Change at Day 240 | 7.2 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Emotional functional scales: Change at Day 268 | 5.9 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Emotional functional scales: Change at Day 296 | 8.4 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Emotional functional scales: Change at Day 324 | 12 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Emotional functional scales: Change at Day 352 | 8.8 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Emotional functional scales: Change at Day 380 | 16 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Cognitive functional scales: Change at Day 7 | -0.4 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Cognitive functional scales: Change at Day 28 | 1.6 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Cognitive functional scales: Change at Day 56 | 1.2 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Cognitive functional scales: Change at Day 78 | 4.4 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Cognitive functional scales: Change at Day 100 | 2.3 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Cognitive functional scales: Change at Day 128 | 5 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Cognitive functional scales: Change at Day 156 | 4.2 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Cognitive functional scales: Change at Day 184 | 4.1 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Cognitive functional scales: Change at Day 212 | 7.4 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Cognitive functional scales: Change at Day 240 | 8.6 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Cognitive functional scales: Change at Day 268 | 5.6 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Cognitive functional scales: Change at Day 296 | 5.2 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Cognitive functional scales: Change at Day 324 | 9.3 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Cognitive functional scales: Change at Day 352 | 4.2 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Cognitive functional scales: Change at Day 380 | 22 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Social functional scales: Change at Day 7 | -28.5 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Social functional scales: Change at Day 28 | -13.8 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Social functional scales: Change at Day 56 | -9.4 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Social functional scales: Change at Day 78 | -3.8 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Social functional scales: Change at Day 100 | -3.5 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Social functional scales: Change at Day 128 | -1.2 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Social functional scales: Change at Day 156 | -1.5 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Social functional scales: Change at Day 184 | 0.4 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Social functional scales: Change at Day 212 | -1.3 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Social functional scales: Change at Day 240 | 1.1 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Social functional scales: Change at Day 268 | -0.5 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Social functional scales: Change at Day 296 | 2.2 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Social functional scales: Change at Day 324 | 0.5 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Social functional scales: Change at Day 352 | -0.1 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Social functional scales: Change at Day 380 | -0.5 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Global health status scale: Change at Day 7 | -9.7 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Global health status scale: Change at Day 28 | -0.6 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Global health status scale: Change at Day 56 | 1.5 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Global health status scale: Change at Day 78 | 4.7 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Global health status scale: Change at Day 100 | 2.5 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Global health status scale: Change at Day 128 | 8.3 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Global health status scale: Change at Day 156 | 8.4 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Global health status scale: Change at Day 184 | 8.9 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Global health status scale: Change at Day 212 | 7.7 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Global health status scale: Change at Day 240 | 9.6 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Global health status scale: Change at Day 268 | 7.8 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Global health status scale: Change at Day 296 | 10.4 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Global health status scale: Change at Day 324 | 11.5 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Global health status scale: Change at Day 352 | 19.9 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Global health status scale: Change at Day 380 | 4.4 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Pain symptom scales: Change at Day 7 | -1.9 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Pain symptom scales: Change at Day 28 | -9.9 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Pain symptom scales: Change at Day 56 | -6.3 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Pain symptom scales: Change at Day 78 | -9.4 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Pain symptom scales: Change at Day 100 | -10.5 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Pain symptom scales: Change at Day 128 | -11.8 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Pain symptom scales: Change at Day 156 | -13.1 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Pain symptom scales: Change at Day 184 | -10 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Pain symptom scales: Change at Day 212 | -11.7 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Pain symptom scales: Change at Day 240 | -16.2 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Pain symptom scales: Change at Day 268 | -16.7 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Pain symptom scales: Change at Day 296 | -15.6 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Pain symptom scales: Change at Day 324 | -14.9 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Pain symptom scales: Change at Day 352 | -17.6 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Pain symptom scales: Change at Day 380 | -0.7 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Fatigue symptom scales: Change at Day 7 | 14.3 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Fatigue symptom scales: Change at Day 28 | 10.3 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Fatigue symptom scales: Change at Day 56 | 4 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Fatigue symptom scales: Change at Day 78 | -5.9 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Fatigue symptom scales: Change at Day 100 | 0 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Fatigue symptom scales: Change at Day 128 | -7.7 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Fatigue symptom scales: Change at Day 156 | -5.1 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Fatigue symptom scales: Change at Day 184 | -8.1 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Fatigue symptom scales: Change at Day 212 | -11.5 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Fatigue symptom scales: Change at Day 240 | -12.6 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Fatigue symptom scales: Change at Day 268 | -13.4 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Fatigue symptom scales: Change at Day 296 | -14.2 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Fatigue symptom scales: Change at Day 324 | -14.6 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Fatigue symptom scales: Change at Day 352 | -15.7 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Fatigue symptom scales: Change at Day 380 | -5.6 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Nausea/vomiting symptom scales: Change at Day 7 | 13.3 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Nausea/vomiting symptom scales: Change at Day 28 | 1.7 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Nausea/vomiting symptom scales: Change at Day 56 | 2.2 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Nausea/vomiting symptom scales: Change at Day 78 | -0.2 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Nausea/vomiting symptom scales: Change at Day 100 | -0.2 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Nausea/vomiting symptom scales: Change at Day 128 | -2.6 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Nausea/vomiting symptom scales: Change at Day 156 | -2.6 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Nausea/vomiting symptom scales: Change at Day 184 | -0.2 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Nausea/vomiting symptom scales: Change at Day 212 | -1 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Nausea/vomiting symptom scales: Change at Day 240 | -3.4 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Nausea/vomiting symptom scales: Change at Day 268 | -2.5 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Nausea/vomiting symptom scales: Change at Day 296 | -3.5 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Nausea/vomiting symptom scales: Change at Day 324 | -2.9 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Nausea/vomiting symptom scales: Change at Day 352 | -4.4 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Nausea/vomiting symptom scales: Change at Day 380 | 4.5 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Dyspnea: Change at Day 7 | 2.6 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Dyspnea: Change at Day 28 | 4.6 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Dyspnea: Change at Day 56 | 1.3 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Dyspnea: Change at Day 78 | -1.9 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Dyspnea: Change at Day 100 | -3 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Dyspnea: Change at Day 128 | -1.5 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Dyspnea: Change at Day 156 | -1.3 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Dyspnea: Change at Day 184 | -2.9 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Dyspnea: Change at Day 212 | -7 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Dyspnea: Change at Day 240 | -4.1 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Dyspnea: Change at Day 268 | -8.7 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Dyspnea: Change at Day 296 | -10.9 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Dyspnea: Change at Day 324 | -7.6 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Dyspnea: Change at Day 352 | -6.5 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Dyspnea: Change at Day 380 | -22.5 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Insomnia: Change at Day 7 | 9.4 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Insomnia: Change at Day 28 | -4.6 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Insomnia: Change at Day 56 | -1.4 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Insomnia: Change at Day 78 | -2.6 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Insomnia: Change at Day 100 | -3.1 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Insomnia: Change at Day 128 | -7.1 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Insomnia: Change at Day 156 | -7.1 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Insomnia: Change at Day 184 | -2.3 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Insomnia: Change at Day 212 | -4.4 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Insomnia: Change at Day 240 | -6.3 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Insomnia: Change at Day 268 | -6.7 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Insomnia: Change at Day 296 | -4.9 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Insomnia: Change at Day 324 | -1.6 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Insomnia: Change at Day 352 | 1 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Insomnia: Change at Day 380 | -18.3 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Appetite loss: Change at Day 7 | 22.2 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Appetite loss: Change at Day 28 | 8.4 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Appetite loss: Change at Day 56 | 2.5 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Appetite loss: Change at Day 78 | -0.7 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Appetite loss: Change at Day 100 | 3 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Appetite loss: Change at Day 128 | -4.3 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Appetite loss: Change at Day 156 | -5 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Appetite loss: Change at Day 184 | -4.7 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Appetite loss: Change at Day 212 | -7.9 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Appetite loss: Change at Day 240 | -10.5 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Appetite loss: Change at Day 268 | -12.4 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Appetite loss: Change at Day 296 | -11 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Appetite loss: Change at Day 324 | -9.5 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Appetite loss: Change at Day 352 | -9.8 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Appetite loss: Change at Day 380 | -6.1 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Constipation: Change at Day 7 | 12.7 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Constipation: Change at Day 28 | -0.1 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Constipation: Change at Day 56 | -2 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Constipation: Change at Day 78 | -6.3 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Constipation: Change at Day 100 | -7 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Constipation: Change at Day 128 | -4.5 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Constipation: Change at Day 156 | -6.3 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Constipation: Change at Day 184 | -8.1 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Constipation: Change at Day 212 | -4.4 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Constipation: Change at Day 240 | -10.1 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Constipation: Change at Day 268 | -6.6 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Constipation: Change at Day 296 | -7.1 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Constipation: Change at Day 324 | -9.3 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Constipation: Change at Day 352 | -12.3 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Constipation: Change at Day 380 | -16.5 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Diarrhea: Change at Day 7 | 1.7 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Diarrhea: Change at Day 28 | -3.1 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Diarrhea: Change at Day 56 | 1.2 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Diarrhea: Change at Day 78 | 5 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Diarrhea: Change at Day 100 | 0.1 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Diarrhea: Change at Day 128 | -1.6 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Diarrhea: Change at Day 156 | 1.1 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Diarrhea: Change at Day 184 | -4.5 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Diarrhea: Change at Day 212 | -6.8 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Diarrhea: Change at Day 240 | -2.6 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Diarrhea: Change at Day 268 | -5.4 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Diarrhea: Change at Day 296 | -8.2 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Diarrhea: Change at Day 324 | -12.2 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Diarrhea: Change at Day 352 | -11.9 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Diarrhea: Change at Day 380 | -26.2 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Financial difficulties: Change at Day 7 | 3.8 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Financial difficulties: Change at Day 28 | -2.7 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Financial difficulties: Change at Day 56 | -1.4 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Financial difficulties: Change at Day 78 | -4.5 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Financial difficulties: Change at Day 100 | -4.3 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Financial difficulties: Change at Day 128 | -6.4 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Financial difficulties: Change at Day 156 | -4.7 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Financial difficulties: Change at Day 184 | -5.2 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Financial difficulties: Change at Day 212 | -2.7 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Financial difficulties: Change at Day 240 | -4.1 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Financial difficulties: Change at Day 268 | -9.1 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Financial difficulties: Change at Day 296 | -8.3 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Financial difficulties: Change at Day 324 | -12 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Financial difficulties: Change at Day 352 | -12.8 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Financial difficulties: Change at Day 380 | -21.2 Score on a scale |
Secondary
Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380
EQ-5D-5L was a 5-item questionnaire consisted of 2 components: a health state profile/a single utility index value and an optional VAS. EQ-5D health state profile/a single utility index value had 5 dimensions including mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 5 response levels: 1 =no problems, 2 =slight problems, 3 =moderate problems, 4 =severe problems and 5 =extreme problems. The scores for the 5 dimensions were used to compute a single utility score ranging from 0 to 1 representing the general health status of the individual. Higher score indicated better health status. EQ-5D VAS was used to record participant's rating for his/her health today and ranging from 0 to 100, where 0 = worst imaginable health state and 100 = best imaginable health state.
Time frame: Baseline, Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380
Population: mITT analysis Set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure and n (number analyzed) signifies those participants who were evaluable for specified time points.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Change at Day 7 | -0.1 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Change at Day 28 | 0 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Change at Day 56 | 0 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Change at Day 78 | 0 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Change at Day 100 | 0 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Change at Day 128 | 0 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Change at Day 156 | 0 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Change at Day 184 | 0 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Change at Day 212 | 0.1 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Change at Day 240 | 0.1 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Change at Day 268 | 0.1 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Change at Day 296 | 0.1 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Change at Day 324 | 0 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Change at Day 352 | 0.1 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Change at Day 380 | -0.1 Score on a scale |
Secondary
Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380
EQ-5D-5L was a 5-item questionnaire consisted of 2 components: a health state profile/a single utility index value and an optional VAS. EQ-5D health state profile/a single utility index value had 5 dimensions including mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 5 response levels: 1 =no problems, 2 =slight problems, 3 =moderate problems, 4 =severe problems and 5 =extreme problems. The scores for the 5 dimensions were used to compute a single utility score ranging from 0 to 1 representing the general health status of the individual. Higher score indicated better health status. EQ-5D VAS was used to record participant's rating for his/her health today and ranging from 0 to 100, where 0 =worst imaginable health state and 100 = best imaginable health state.
Time frame: Baseline, Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380
Population: mITT analysis Set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure and n (number analyzed) signifies those participants who were evaluable for specified time points.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Change at Day 7 | -6.7 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Change at Day 28 | 0.6 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Change at Day 56 | 2.2 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Change at Day 78 | 5.3 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Change at Day 100 | 1.9 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Change at Day 128 | 6.4 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Change at Day 156 | 4.8 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Change at Day 184 | 6.1 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Change at Day 212 | 9.6 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Change at Day 240 | 11 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Change at Day 268 | 7.2 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Change at Day 296 | 10 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Change at Day 324 | 11.9 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Change at Day 352 | 10.2 Score on a scale |
| Phase 1b (US Population) | Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 | Change at Day 380 | -2 Score on a scale |