Tumors
Conditions
Keywords
Solid Tumors, E7090
Brief summary
This is a Phase 1 study of E7090 in subjects with advanced solid tumors. This study will be conducted in 2 parts: 1. Part 1 will be the dose escalation portion of this study to determine the maximum tolerated dose in subjects with solid tumors, and 2. Part 2 will comprise cohort expansions to further characterize the safety and tolerability of E7090 and to assess preliminary efficacy of E7090 in subjects with solid tumors characterized by genetic abnormalities in FGF/FGFR pathway.
Interventions
DRUGE7090
Sponsors
Eisai Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Part 1and Part 2 1. Provide written informed consent 2. Male or female subjects age \>= 20 years at the time of informed consent 3. Subjects with a histological and/or cytological diagnosis of solid tumor 4. Subjects who failed standard therapies, or for which no appropriate treatment is available. 5. Subjects with Performance Status (PS) score of 0-1 established by Eastern Cooperative Oncology Group (ECOG) 6. Subjects who are expected to survive for 3 months or longer after starting administration of the investigational drug. Inclusion Criteria: Part 2 only 7. Subjects with tumor expressing genetic abnormality in FGF/FGFR (fibroblast growth factor/ fibroblast growth factor receptor)pathway.
Exclusion criteria
1. Patients with brain metastasis who have clinical symptoms or requiring treatment. 2. Medical history of clinically significant cardiovascular impairment 3. Concomitant systemic infection requiring medical treatment 4. Effusion requiring drainage 5. Known intolerance to the study drug (or any of excipients) 6. Subjects whose toxicity of previous treatment has not recovered to Grade 1 or lower (except for alopecia). 7. Inability to take oral medication, or malabsorption syndrome, or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) that might impair the bioavailability of E7090. 8. Psychiatric disorder (e.g., alcohol or drug dependency) judged to be ineligible for study entry by the investigator or subinvestigator 9. Females who are pregnant or breastfeeding 10. Any subjects who are judged by the principal investigator or the other investigators to be inappropriate as subjects in this clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Number of Participants With Dose-limiting Toxicities (DLTs) | Cycle 0 (Cycle length= 7 days) up to Cycle 1 (Cycle length= 28 days) | DLT was graded using Common Terminology Criteria for Adverse Events version 4.03 as follows: a. febrile neutropenia, or Grade 4 neutropenia persisting for greater than or equal to (\>=) 7 days, b. Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia requiring platelet transfusions, c. Grade \>=3 non-hematological toxicity, except for: clinically insignificant laboratory abnormalities, toxicity Grade less than or equal to (\<=) 2 by best supportive care; d. potentially clinically significant, new radiographic mineralization in soft tissue, kidneys, intestines, heart, lungs, or other organs; e. Hyperphosphatemia meeting either for: serum phosphate level greater than (\>) 7 milligram per deciliter (mg/dL) persisting for \>=7 days despite best treatment, serum phosphate level \>9 mg/dL despite best treatment; f. treatment interruption for \>=8 days during Cycle 0; Cycle 1 required by E7090-related toxicity, except for treatment interruption for \>=8 days for reasons other than toxicity. |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From the start of study drug administration up to 2 year 9 months | A TEAE was defined as an adverse event (AE) that emerged during the time from the first dose of study drug to 30 days following the last dose of study drug, having been absent at pretreatment (Baseline) or reemerged during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous. A Serious AE is any untoward medical occurrence that at any dose: resulted in death; was life threatening (that is, the participant was at immediate risk of death from the AE as it occurred; this does not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death) required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best Overall Response (BOR) | From the date of first dose of study drug up to 2 years and 8 months | Tumor assessment (target lesion, non-target lesion, and presence or absence of new lesion) was performed based on RECIST v1.1. Tumor marker was also measured. FDG-PET CT (fluorodeoxyglucose- Positron emission tomography computed tomography) also evaluated. Best overall responses were complete response (CR), partial response (PR), stable disease (SD), progression of disease (PD), and not evaluable (NE). CR was defined as disappearance of all target lesions and non-target lesions (a short diameter is \<10 mm if it exists in a lymph node). PR was defined as at least 30% decrease in the sum of the LD of all target lesions, as compared with baseline summed LD. SD was defined as no known evidence of progressive disease or new bone lesions where SD was achieved at \>=7 weeks after first dose. |
| Part 2: Objective Response Rate (ORR) | From screening up to 2 years and 8 months | ORR was defined as a percentage of participants with BOR of CR or PR. ORR was assessed using RECIST 1.1. CR was defined as disappearance of all target lesions and non-target lesions (a short diameter is \<10 mm if it exists in a lymph node). PR was defined as at least 30% decrease in the sum of the LD of all target lesions, as compared with baseline summed LD. |
| Part 2: Disease Control Rate (DCR) | From the date of first dose of study drug up to 2 years and 8 months | DCR was defined as the percentage of participants with BOR of CR, PR or SD. DCR was assessed based on RECIST 1.1. CR was defined as disappearance of all target lesions and non-target lesions (a short diameter is \<10 mm if it exists in a lymph node). PR was defined as at least 30% decrease in the sum of the LD of all target lesions, as compared with Baseline summed LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. SD was defined as no known evidence of progressive disease or new bone lesions where SD was achieved at \>= 7 weeks after first dose. |
| Part 2: Overall Survival (OS) | From the date of first dose of study drug up to 2 years and 8 months | OS was defined as the time from the date of first dose to the date of death from any cause. OS was estimated by using Kaplan-Meier method. |
| Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E7090 | Part 1: Cycle 0 Day 1: 0-72 hours post dose (Cycle 0 is 7 days); Part 2: Cycle 1 Day 1: 0-24 hours post dose; (Cycle 1 is 28 days) | — |
| AUC(0-24h): Area Under the Plasma Concentration-time Curve From Zero Time to 24 Hours | Part 1: Cycle 0 Day 1: 0-24 hours post dose (Cycle 0 is 7 days); Part 2: Cycle 1 Day 1: 0-24 hours post dose (Cycle 1 is 28 days) | — |
| Part 1: CL/F: Apparent Total Clearance for E7090 | Part 1: Cycle 0 Day 1: 0-72 hours post dose (Cycle 0 is 7 days) | — |
| Cmax: Maximum Observed Plasma Concentration for E7090 | Part 1: Cycle 0 Day 1: 0-72 hours post dose (Cycle 0 is 7 days); Part 2: Cycle 1 Day 1: 0-24 hours post dose; (Cycle 1 is 28 days) | — |
| Part 2: Progression- Free Survival (PFS) | From the date of first dose of study drug up to 2 years and 8 months | PFS was defined as the time from the date of first dose to the first documented date of event (disease progression or death from any cause, whichever occurs first). PD was defined as at least a 20 percent (%) increase in the sum of LD of target and non-target lesions as compared with the smallest sum of long diameter (LD) and the increase of LD was at least 5 millimeter (mm) (including new lesions). The tumor assessment is based on Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 criteria and was estimated using Kaplan-Meier method. |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the study at 18 investigative sites in Japan from 28 October 2014 to 03 September 2021.
Pre-assignment details
A total of 40 participants were enrolled in this study. This study consisted of two parts: Part 1 and Part 2. In Part 1, 24 participants were enrolled and received study treatment and in Part 2, 16 participants were enrolled and received the study treatment.
Participants by arm
| Arm | Count |
|---|---|
| Part 1: E7090 1 mg With Solid Tumor Participants with solid tumor received E7090 1 milligram (mg) capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. | 2 |
| Part 1: E7090 2 mg With Solid Tumor Participants with solid tumor received E7090 2 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. | 2 |
| Part 1: E7090 4 mg With Solid Tumor Participants with solid tumor received E7090 4 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. | 2 |
| Part 1: E7090 8 mg With Solid Tumor Participants with solid tumor received E7090 8 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in 28-days treatment cycles for Cycle 1 and 2 and subsequent cycles unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. | 2 |
| Part 1: E7090 16 mg With Solid Tumor Participants with solid tumor received E7090 16 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in 28-days treatment cycles for Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. | 2 |
| Part 1: E7090 30 mg With Solid Tumor Participants with solid tumor received E7090 30 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. | 2 |
| Part 1: E7090 60 mg With Solid Tumor Participants with solid tumor received E7090 60 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. | 3 |
| Part 1: E7090 100 mg With Solid Tumor Participants with solid tumor received E7090 100 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. | 3 |
| Part 1: E7090 140 mg With Solid Tumor Participants with solid tumor received E7090 140 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. | 3 |
| Part 1: E7090 180 mg With Solid Tumor Participants with solid tumor received E7090 180 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. | 3 |
| Part 2: E7090 140 mg With Gastric Cancer Participants with gastric cancer received E7090 140 mg capsules orally, on Days 1 and 8 of Cycle 1 in the fasting state and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. | 10 |
| Part 2: E7090 140 mg With Cholangiocarcinoma Participants with Cholangiocarcinoma received E7090 140 mg capsules orally, on Days 1 and 8 of Cycle 1 in the fasting state and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. | 6 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Radiological Disease Progression | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 0 |
| Overall Study | Subject Choice | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Part 1: E7090 1 mg With Solid Tumor | Part 1: E7090 2 mg With Solid Tumor | Part 1: E7090 4 mg With Solid Tumor | Part 1: E7090 8 mg With Solid Tumor | Part 1: E7090 16 mg With Solid Tumor | Part 1: E7090 30 mg With Solid Tumor | Part 1: E7090 60 mg With Solid Tumor | Part 1: E7090 100 mg With Solid Tumor | Part 1: E7090 140 mg With Solid Tumor | Part 1: E7090 180 mg With Solid Tumor | Part 2: E7090 140 mg With Gastric Cancer | Part 2: E7090 140 mg With Cholangiocarcinoma | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 67.5 years STANDARD_DEVIATION 6.36 | 68.0 years STANDARD_DEVIATION 5.66 | 57.5 years STANDARD_DEVIATION 3.54 | 58.5 years STANDARD_DEVIATION 23.33 | 58.5 years STANDARD_DEVIATION 6.36 | 58.5 years STANDARD_DEVIATION 6.36 | 71.0 years STANDARD_DEVIATION 3.61 | 67.0 years STANDARD_DEVIATION 1 | 64.0 years STANDARD_DEVIATION 6.93 | 53.3 years STANDARD_DEVIATION 11.93 | 67.5 years STANDARD_DEVIATION 9.07 | 53.7 years STANDARD_DEVIATION 10.65 | 62.5 years STANDARD_DEVIATION 10.05 |
| Race/Ethnicity, Customized Chinese | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Japanese | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 1 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 10 Participants | 6 Participants | 39 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 10 Participants | 6 Participants | 40 Participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 3 Participants | 3 Participants | 1 Participants | 17 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 2 Participants | 2 Participants | 0 Participants | 7 Participants | 5 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 2 | 0 / 2 | 0 / 2 | 0 / 2 | 0 / 2 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 | 10 / 10 | 5 / 6 |
| other Total, other adverse events | 2 / 2 | 1 / 2 | 1 / 2 | 2 / 2 | 2 / 2 | 2 / 2 | 3 / 3 | 3 / 3 | 3 / 3 | 3 / 3 | 10 / 10 | 6 / 6 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 | 0 / 2 | 2 / 2 | 0 / 2 | 1 / 2 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 | 4 / 10 | 1 / 6 |
Outcome results
Primary
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
A TEAE was defined as an adverse event (AE) that emerged during the time from the first dose of study drug to 30 days following the last dose of study drug, having been absent at pretreatment (Baseline) or reemerged during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous. A Serious AE is any untoward medical occurrence that at any dose: resulted in death; was life threatening (that is, the participant was at immediate risk of death from the AE as it occurred; this does not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death) required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria.
Time frame: From the start of study drug administration up to 2 year 9 months
Population: The safety analysis set was the group of participants who received at least 1 dose of E7090. This outcome measure was planned to be analyzed for Part 1 and Part 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: E7090 1 mg With Solid Tumor | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs | 2 Participants |
| Part 1: E7090 1 mg With Solid Tumor | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part 1: E7090 2 mg With Solid Tumor | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs | 1 Participants |
| Part 1: E7090 2 mg With Solid Tumor | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part 1: E7090 4 mg With Solid Tumor | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs | 1 Participants |
| Part 1: E7090 4 mg With Solid Tumor | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part 1: E7090 8 mg With Solid Tumor | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs | 2 Participants |
| Part 1: E7090 8 mg With Solid Tumor | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 2 Participants |
| Part 1: E7090 16 mg With Solid Tumor | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part 1: E7090 16 mg With Solid Tumor | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs | 2 Participants |
| Part 1: E7090 30 mg With Solid Tumor | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs | 2 Participants |
| Part 1: E7090 30 mg With Solid Tumor | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 1 Participants |
| Part 1: E7090 60 mg With Solid Tumor | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part 1: E7090 60 mg With Solid Tumor | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs | 3 Participants |
| Part 1: E7090 100 mg With Solid Tumor | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs | 3 Participants |
| Part 1: E7090 100 mg With Solid Tumor | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part 1: E7090 140 mg With Solid Tumor | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs | 3 Participants |
| Part 1: E7090 140 mg With Solid Tumor | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part 1: E7090 180 mg With Solid Tumor | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs | 3 Participants |
| Part 1: E7090 180 mg With Solid Tumor | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part 2: E7090 140 mg With Gastric Cancer | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 4 Participants |
| Part 2: E7090 140 mg With Gastric Cancer | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs | 10 Participants |
| Part 2: E7090 140 mg With Cholangiocarcinoma | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 1 Participants |
| Part 2: E7090 140 mg With Cholangiocarcinoma | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs | 6 Participants |
Primary
Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)
DLT was graded using Common Terminology Criteria for Adverse Events version 4.03 as follows: a. febrile neutropenia, or Grade 4 neutropenia persisting for greater than or equal to (\>=) 7 days, b. Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia requiring platelet transfusions, c. Grade \>=3 non-hematological toxicity, except for: clinically insignificant laboratory abnormalities, toxicity Grade less than or equal to (\<=) 2 by best supportive care; d. potentially clinically significant, new radiographic mineralization in soft tissue, kidneys, intestines, heart, lungs, or other organs; e. Hyperphosphatemia meeting either for: serum phosphate level greater than (\>) 7 milligram per deciliter (mg/dL) persisting for \>=7 days despite best treatment, serum phosphate level \>9 mg/dL despite best treatment; f. treatment interruption for \>=8 days during Cycle 0; Cycle 1 required by E7090-related toxicity, except for treatment interruption for \>=8 days for reasons other than toxicity.
Time frame: Cycle 0 (Cycle length= 7 days) up to Cycle 1 (Cycle length= 28 days)
Population: The DLT analysis set was the group of participants in the Part 1 who completed Cycle 0 and Cycle 1 treatment of E7090 with at least 75% compliance and were evaluated for DLT, and those who developed DLT during Cycle 0 or Cycle 1. This outcome measure was planned to be analyzed for Part 1 only.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: E7090 1 mg With Solid Tumor | Part 1: Number of Participants With Dose-limiting Toxicities (DLTs) | 0 Participants |
| Part 1: E7090 2 mg With Solid Tumor | Part 1: Number of Participants With Dose-limiting Toxicities (DLTs) | 0 Participants |
| Part 1: E7090 4 mg With Solid Tumor | Part 1: Number of Participants With Dose-limiting Toxicities (DLTs) | 0 Participants |
| Part 1: E7090 8 mg With Solid Tumor | Part 1: Number of Participants With Dose-limiting Toxicities (DLTs) | 0 Participants |
| Part 1: E7090 16 mg With Solid Tumor | Part 1: Number of Participants With Dose-limiting Toxicities (DLTs) | 0 Participants |
| Part 1: E7090 30 mg With Solid Tumor | Part 1: Number of Participants With Dose-limiting Toxicities (DLTs) | 0 Participants |
| Part 1: E7090 60 mg With Solid Tumor | Part 1: Number of Participants With Dose-limiting Toxicities (DLTs) | 0 Participants |
| Part 1: E7090 100 mg With Solid Tumor | Part 1: Number of Participants With Dose-limiting Toxicities (DLTs) | 0 Participants |
| Part 1: E7090 140 mg With Solid Tumor | Part 1: Number of Participants With Dose-limiting Toxicities (DLTs) | 0 Participants |
| Part 1: E7090 180 mg With Solid Tumor | Part 1: Number of Participants With Dose-limiting Toxicities (DLTs) | 1 Participants |
Secondary
AUC(0-24h): Area Under the Plasma Concentration-time Curve From Zero Time to 24 Hours
Time frame: Part 1: Cycle 0 Day 1: 0-24 hours post dose (Cycle 0 is 7 days); Part 2: Cycle 1 Day 1: 0-24 hours post dose (Cycle 1 is 28 days)
Population: The PK analysis set was the group of participants who received at least 1 dose of E7090 and had sufficient PK data to derive at least 1 PK parameter. Here overall number of participants analyzed are those who were evaluable for this outcome measure. This outcome measure was planned to be analyzed for Part 1 and Part 2.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: E7090 1 mg With Solid Tumor | AUC(0-24h): Area Under the Plasma Concentration-time Curve From Zero Time to 24 Hours | NA h*ng/mL | — |
| Part 1: E7090 2 mg With Solid Tumor | AUC(0-24h): Area Under the Plasma Concentration-time Curve From Zero Time to 24 Hours | NA h*ng/mL | — |
| Part 1: E7090 4 mg With Solid Tumor | AUC(0-24h): Area Under the Plasma Concentration-time Curve From Zero Time to 24 Hours | 5.71 h*ng/mL | — |
| Part 1: E7090 8 mg With Solid Tumor | AUC(0-24h): Area Under the Plasma Concentration-time Curve From Zero Time to 24 Hours | 19.8 h*ng/mL | — |
| Part 1: E7090 16 mg With Solid Tumor | AUC(0-24h): Area Under the Plasma Concentration-time Curve From Zero Time to 24 Hours | 55.1 h*ng/mL | Geometric Coefficient of Variation 45.2 |
| Part 1: E7090 30 mg With Solid Tumor | AUC(0-24h): Area Under the Plasma Concentration-time Curve From Zero Time to 24 Hours | 164 h*ng/mL | Geometric Coefficient of Variation 39.4 |
| Part 1: E7090 60 mg With Solid Tumor | AUC(0-24h): Area Under the Plasma Concentration-time Curve From Zero Time to 24 Hours | 341 h*ng/mL | Geometric Coefficient of Variation 31.2 |
| Part 1: E7090 100 mg With Solid Tumor | AUC(0-24h): Area Under the Plasma Concentration-time Curve From Zero Time to 24 Hours | 788 h*ng/mL | Geometric Coefficient of Variation 52.2 |
| Part 1: E7090 140 mg With Solid Tumor | AUC(0-24h): Area Under the Plasma Concentration-time Curve From Zero Time to 24 Hours | 2100 h*ng/mL | Geometric Coefficient of Variation 80.5 |
| Part 1: E7090 180 mg With Solid Tumor | AUC(0-24h): Area Under the Plasma Concentration-time Curve From Zero Time to 24 Hours | 1760 h*ng/mL | Geometric Coefficient of Variation 50.4 |
| Part 2: E7090 140 mg With Gastric Cancer | AUC(0-24h): Area Under the Plasma Concentration-time Curve From Zero Time to 24 Hours | 1590 h*ng/mL | Geometric Coefficient of Variation 70.5 |
| Part 2: E7090 140 mg With Cholangiocarcinoma | AUC(0-24h): Area Under the Plasma Concentration-time Curve From Zero Time to 24 Hours | 618 h*ng/mL | Geometric Coefficient of Variation 87.7 |
Secondary
Best Overall Response (BOR)
Tumor assessment (target lesion, non-target lesion, and presence or absence of new lesion) was performed based on RECIST v1.1. Tumor marker was also measured. FDG-PET CT (fluorodeoxyglucose- Positron emission tomography computed tomography) also evaluated. Best overall responses were complete response (CR), partial response (PR), stable disease (SD), progression of disease (PD), and not evaluable (NE). CR was defined as disappearance of all target lesions and non-target lesions (a short diameter is \<10 mm if it exists in a lymph node). PR was defined as at least 30% decrease in the sum of the LD of all target lesions, as compared with baseline summed LD. SD was defined as no known evidence of progressive disease or new bone lesions where SD was achieved at \>=7 weeks after first dose.
Time frame: From the date of first dose of study drug up to 2 years and 8 months
Population: The efficacy analysis set was the group of participants who received at least 1 dose of E7090 and had both baseline and at least 1 post-baseline tumor assessments. This outcome measure was planned to be analyzed for Part 1 and Part 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: E7090 1 mg With Solid Tumor | Best Overall Response (BOR) | Not Evaluable (NE) | 0 Participants |
| Part 1: E7090 1 mg With Solid Tumor | Best Overall Response (BOR) | Progressive Disease (PD) | 1 Participants |
| Part 1: E7090 1 mg With Solid Tumor | Best Overall Response (BOR) | Partial Response (PR) | 0 Participants |
| Part 1: E7090 1 mg With Solid Tumor | Best Overall Response (BOR) | Complete Response (CR) | 0 Participants |
| Part 1: E7090 1 mg With Solid Tumor | Best Overall Response (BOR) | Stable Disease (SD) | 1 Participants |
| Part 1: E7090 2 mg With Solid Tumor | Best Overall Response (BOR) | Complete Response (CR) | 0 Participants |
| Part 1: E7090 2 mg With Solid Tumor | Best Overall Response (BOR) | Stable Disease (SD) | 0 Participants |
| Part 1: E7090 2 mg With Solid Tumor | Best Overall Response (BOR) | Not Evaluable (NE) | 0 Participants |
| Part 1: E7090 2 mg With Solid Tumor | Best Overall Response (BOR) | Progressive Disease (PD) | 2 Participants |
| Part 1: E7090 2 mg With Solid Tumor | Best Overall Response (BOR) | Partial Response (PR) | 0 Participants |
| Part 1: E7090 4 mg With Solid Tumor | Best Overall Response (BOR) | Stable Disease (SD) | 0 Participants |
| Part 1: E7090 4 mg With Solid Tumor | Best Overall Response (BOR) | Not Evaluable (NE) | 1 Participants |
| Part 1: E7090 4 mg With Solid Tumor | Best Overall Response (BOR) | Complete Response (CR) | 0 Participants |
| Part 1: E7090 4 mg With Solid Tumor | Best Overall Response (BOR) | Progressive Disease (PD) | 1 Participants |
| Part 1: E7090 4 mg With Solid Tumor | Best Overall Response (BOR) | Partial Response (PR) | 0 Participants |
| Part 1: E7090 8 mg With Solid Tumor | Best Overall Response (BOR) | Complete Response (CR) | 0 Participants |
| Part 1: E7090 8 mg With Solid Tumor | Best Overall Response (BOR) | Stable Disease (SD) | 0 Participants |
| Part 1: E7090 8 mg With Solid Tumor | Best Overall Response (BOR) | Partial Response (PR) | 0 Participants |
| Part 1: E7090 8 mg With Solid Tumor | Best Overall Response (BOR) | Progressive Disease (PD) | 2 Participants |
| Part 1: E7090 8 mg With Solid Tumor | Best Overall Response (BOR) | Not Evaluable (NE) | 0 Participants |
| Part 1: E7090 16 mg With Solid Tumor | Best Overall Response (BOR) | Complete Response (CR) | 0 Participants |
| Part 1: E7090 16 mg With Solid Tumor | Best Overall Response (BOR) | Progressive Disease (PD) | 1 Participants |
| Part 1: E7090 16 mg With Solid Tumor | Best Overall Response (BOR) | Partial Response (PR) | 0 Participants |
| Part 1: E7090 16 mg With Solid Tumor | Best Overall Response (BOR) | Not Evaluable (NE) | 0 Participants |
| Part 1: E7090 16 mg With Solid Tumor | Best Overall Response (BOR) | Stable Disease (SD) | 1 Participants |
| Part 1: E7090 30 mg With Solid Tumor | Best Overall Response (BOR) | Partial Response (PR) | 0 Participants |
| Part 1: E7090 30 mg With Solid Tumor | Best Overall Response (BOR) | Complete Response (CR) | 0 Participants |
| Part 1: E7090 30 mg With Solid Tumor | Best Overall Response (BOR) | Stable Disease (SD) | 1 Participants |
| Part 1: E7090 30 mg With Solid Tumor | Best Overall Response (BOR) | Progressive Disease (PD) | 1 Participants |
| Part 1: E7090 30 mg With Solid Tumor | Best Overall Response (BOR) | Not Evaluable (NE) | 0 Participants |
| Part 1: E7090 60 mg With Solid Tumor | Best Overall Response (BOR) | Complete Response (CR) | 0 Participants |
| Part 1: E7090 60 mg With Solid Tumor | Best Overall Response (BOR) | Stable Disease (SD) | 1 Participants |
| Part 1: E7090 60 mg With Solid Tumor | Best Overall Response (BOR) | Partial Response (PR) | 0 Participants |
| Part 1: E7090 60 mg With Solid Tumor | Best Overall Response (BOR) | Progressive Disease (PD) | 2 Participants |
| Part 1: E7090 60 mg With Solid Tumor | Best Overall Response (BOR) | Not Evaluable (NE) | 0 Participants |
| Part 1: E7090 100 mg With Solid Tumor | Best Overall Response (BOR) | Progressive Disease (PD) | 2 Participants |
| Part 1: E7090 100 mg With Solid Tumor | Best Overall Response (BOR) | Complete Response (CR) | 0 Participants |
| Part 1: E7090 100 mg With Solid Tumor | Best Overall Response (BOR) | Partial Response (PR) | 0 Participants |
| Part 1: E7090 100 mg With Solid Tumor | Best Overall Response (BOR) | Stable Disease (SD) | 1 Participants |
| Part 1: E7090 100 mg With Solid Tumor | Best Overall Response (BOR) | Not Evaluable (NE) | 0 Participants |
| Part 1: E7090 140 mg With Solid Tumor | Best Overall Response (BOR) | Not Evaluable (NE) | 1 Participants |
| Part 1: E7090 140 mg With Solid Tumor | Best Overall Response (BOR) | Stable Disease (SD) | 1 Participants |
| Part 1: E7090 140 mg With Solid Tumor | Best Overall Response (BOR) | Complete Response (CR) | 0 Participants |
| Part 1: E7090 140 mg With Solid Tumor | Best Overall Response (BOR) | Progressive Disease (PD) | 1 Participants |
| Part 1: E7090 140 mg With Solid Tumor | Best Overall Response (BOR) | Partial Response (PR) | 0 Participants |
| Part 1: E7090 180 mg With Solid Tumor | Best Overall Response (BOR) | Progressive Disease (PD) | 1 Participants |
| Part 1: E7090 180 mg With Solid Tumor | Best Overall Response (BOR) | Partial Response (PR) | 1 Participants |
| Part 1: E7090 180 mg With Solid Tumor | Best Overall Response (BOR) | Not Evaluable (NE) | 0 Participants |
| Part 1: E7090 180 mg With Solid Tumor | Best Overall Response (BOR) | Complete Response (CR) | 0 Participants |
| Part 1: E7090 180 mg With Solid Tumor | Best Overall Response (BOR) | Stable Disease (SD) | 1 Participants |
| Part 2: E7090 140 mg With Gastric Cancer | Best Overall Response (BOR) | Partial Response (PR) | 1 Participants |
| Part 2: E7090 140 mg With Gastric Cancer | Best Overall Response (BOR) | Complete Response (CR) | 0 Participants |
| Part 2: E7090 140 mg With Gastric Cancer | Best Overall Response (BOR) | Not Evaluable (NE) | 0 Participants |
| Part 2: E7090 140 mg With Gastric Cancer | Best Overall Response (BOR) | Progressive Disease (PD) | 4 Participants |
| Part 2: E7090 140 mg With Gastric Cancer | Best Overall Response (BOR) | Stable Disease (SD) | 4 Participants |
| Part 2: E7090 140 mg With Cholangiocarcinoma | Best Overall Response (BOR) | Not Evaluable (NE) | 0 Participants |
| Part 2: E7090 140 mg With Cholangiocarcinoma | Best Overall Response (BOR) | Stable Disease (SD) | 1 Participants |
| Part 2: E7090 140 mg With Cholangiocarcinoma | Best Overall Response (BOR) | Progressive Disease (PD) | 0 Participants |
| Part 2: E7090 140 mg With Cholangiocarcinoma | Best Overall Response (BOR) | Partial Response (PR) | 5 Participants |
| Part 2: E7090 140 mg With Cholangiocarcinoma | Best Overall Response (BOR) | Complete Response (CR) | 0 Participants |
Secondary
Cmax: Maximum Observed Plasma Concentration for E7090
Time frame: Part 1: Cycle 0 Day 1: 0-72 hours post dose (Cycle 0 is 7 days); Part 2: Cycle 1 Day 1: 0-24 hours post dose; (Cycle 1 is 28 days)
Population: The pharmacokinetic (PK) analysis set was the group of participants who received at least 1 dose of E7090 and had sufficient PK data to derive at least 1 PK parameter. This outcome measure was planned to be analyzed for Part 1 and Part 2.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: E7090 1 mg With Solid Tumor | Cmax: Maximum Observed Plasma Concentration for E7090 | NA nanogram per milliliter (ng/mL) | — |
| Part 1: E7090 2 mg With Solid Tumor | Cmax: Maximum Observed Plasma Concentration for E7090 | NA nanogram per milliliter (ng/mL) | — |
| Part 1: E7090 4 mg With Solid Tumor | Cmax: Maximum Observed Plasma Concentration for E7090 | 1.27 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 112 |
| Part 1: E7090 8 mg With Solid Tumor | Cmax: Maximum Observed Plasma Concentration for E7090 | 2.89 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 4.41 |
| Part 1: E7090 16 mg With Solid Tumor | Cmax: Maximum Observed Plasma Concentration for E7090 | 8.54 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 86.7 |
| Part 1: E7090 30 mg With Solid Tumor | Cmax: Maximum Observed Plasma Concentration for E7090 | 23.9 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 98.1 |
| Part 1: E7090 60 mg With Solid Tumor | Cmax: Maximum Observed Plasma Concentration for E7090 | 38.5 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 11.9 |
| Part 1: E7090 100 mg With Solid Tumor | Cmax: Maximum Observed Plasma Concentration for E7090 | 82.5 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 34.9 |
| Part 1: E7090 140 mg With Solid Tumor | Cmax: Maximum Observed Plasma Concentration for E7090 | 206 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 58.7 |
| Part 1: E7090 180 mg With Solid Tumor | Cmax: Maximum Observed Plasma Concentration for E7090 | 140 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 34.6 |
| Part 2: E7090 140 mg With Gastric Cancer | Cmax: Maximum Observed Plasma Concentration for E7090 | 188 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 53.2 |
| Part 2: E7090 140 mg With Cholangiocarcinoma | Cmax: Maximum Observed Plasma Concentration for E7090 | 59.4 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 107 |
Secondary
Part 1: CL/F: Apparent Total Clearance for E7090
Time frame: Part 1: Cycle 0 Day 1: 0-72 hours post dose (Cycle 0 is 7 days)
Population: The PK analysis set was the group of participants who received at least 1 dose of E7090 and had sufficient PK data to derive at least 1 PK parameter. This outcome measure was planned to be analyzed for Part 1 only.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: E7090 1 mg With Solid Tumor | Part 1: CL/F: Apparent Total Clearance for E7090 | NA Liter per hour (L/h) | — |
| Part 1: E7090 2 mg With Solid Tumor | Part 1: CL/F: Apparent Total Clearance for E7090 | NA Liter per hour (L/h) | — |
| Part 1: E7090 4 mg With Solid Tumor | Part 1: CL/F: Apparent Total Clearance for E7090 | 700 Liter per hour (L/h) | — |
| Part 1: E7090 8 mg With Solid Tumor | Part 1: CL/F: Apparent Total Clearance for E7090 | NA Liter per hour (L/h) | — |
| Part 1: E7090 16 mg With Solid Tumor | Part 1: CL/F: Apparent Total Clearance for E7090 | 243 Liter per hour (L/h) | Geometric Coefficient of Variation 60.2 |
| Part 1: E7090 30 mg With Solid Tumor | Part 1: CL/F: Apparent Total Clearance for E7090 | 126 Liter per hour (L/h) | Geometric Coefficient of Variation 14.6 |
| Part 1: E7090 60 mg With Solid Tumor | Part 1: CL/F: Apparent Total Clearance for E7090 | 116 Liter per hour (L/h) | Geometric Coefficient of Variation 41.2 |
| Part 1: E7090 100 mg With Solid Tumor | Part 1: CL/F: Apparent Total Clearance for E7090 | 95.5 Liter per hour (L/h) | Geometric Coefficient of Variation 48.8 |
| Part 1: E7090 140 mg With Solid Tumor | Part 1: CL/F: Apparent Total Clearance for E7090 | 46.7 Liter per hour (L/h) | Geometric Coefficient of Variation 109 |
| Part 1: E7090 180 mg With Solid Tumor | Part 1: CL/F: Apparent Total Clearance for E7090 | 66.7 Liter per hour (L/h) | Geometric Coefficient of Variation 41.8 |
Secondary
Part 2: Disease Control Rate (DCR)
DCR was defined as the percentage of participants with BOR of CR, PR or SD. DCR was assessed based on RECIST 1.1. CR was defined as disappearance of all target lesions and non-target lesions (a short diameter is \<10 mm if it exists in a lymph node). PR was defined as at least 30% decrease in the sum of the LD of all target lesions, as compared with Baseline summed LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. SD was defined as no known evidence of progressive disease or new bone lesions where SD was achieved at \>= 7 weeks after first dose.
Time frame: From the date of first dose of study drug up to 2 years and 8 months
Population: The efficacy analysis set was the group of participants who received at least 1 dose of E7090 and had both baseline and at least 1 post-baseline tumor assessments. This outcome measure was planned to be analyzed for Part 2 only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: E7090 1 mg With Solid Tumor | Part 2: Disease Control Rate (DCR) | 55.6 percentage of participants |
| Part 1: E7090 2 mg With Solid Tumor | Part 2: Disease Control Rate (DCR) | 100.0 percentage of participants |
Secondary
Part 2: Objective Response Rate (ORR)
ORR was defined as a percentage of participants with BOR of CR or PR. ORR was assessed using RECIST 1.1. CR was defined as disappearance of all target lesions and non-target lesions (a short diameter is \<10 mm if it exists in a lymph node). PR was defined as at least 30% decrease in the sum of the LD of all target lesions, as compared with baseline summed LD.
Time frame: From screening up to 2 years and 8 months
Population: The efficacy analysis set was the group of participants who received at least 1 dose of E7090 and had both baseline and at least 1 post-baseline tumor assessments. This outcome measure was planned to be analyzed for Part 2 only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: E7090 1 mg With Solid Tumor | Part 2: Objective Response Rate (ORR) | 11.1 percentage of participants |
| Part 1: E7090 2 mg With Solid Tumor | Part 2: Objective Response Rate (ORR) | 83.3 percentage of participants |
Secondary
Part 2: Overall Survival (OS)
OS was defined as the time from the date of first dose to the date of death from any cause. OS was estimated by using Kaplan-Meier method.
Time frame: From the date of first dose of study drug up to 2 years and 8 months
Population: The efficacy analysis set was the group of participants who received at least 1 dose of E7090 and had both baseline and at least 1 post-baseline tumor assessments. This outcome measure was planned to be analyzed for Part 2 only.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: E7090 1 mg With Solid Tumor | Part 2: Overall Survival (OS) | 4.27 months |
| Part 1: E7090 2 mg With Solid Tumor | Part 2: Overall Survival (OS) | 22.49 months |
Secondary
Part 2: Progression- Free Survival (PFS)
PFS was defined as the time from the date of first dose to the first documented date of event (disease progression or death from any cause, whichever occurs first). PD was defined as at least a 20 percent (%) increase in the sum of LD of target and non-target lesions as compared with the smallest sum of long diameter (LD) and the increase of LD was at least 5 millimeter (mm) (including new lesions). The tumor assessment is based on Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 criteria and was estimated using Kaplan-Meier method.
Time frame: From the date of first dose of study drug up to 2 years and 8 months
Population: The efficacy analysis set was the group of participants who received at least 1 dose of E7090 and had both baseline and at least 1 post-baseline tumor assessments. This outcome measure was planned to be analyzed for Part 2 only.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: E7090 1 mg With Solid Tumor | Part 2: Progression- Free Survival (PFS) | 3.25 months |
| Part 1: E7090 2 mg With Solid Tumor | Part 2: Progression- Free Survival (PFS) | 8.26 months |
Secondary
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E7090
Time frame: Part 1: Cycle 0 Day 1: 0-72 hours post dose (Cycle 0 is 7 days); Part 2: Cycle 1 Day 1: 0-24 hours post dose; (Cycle 1 is 28 days)
Population: The PK analysis set was the group of participants who received at least 1 dose of E7090 and had sufficient PK data to derive at least 1 PK parameter. This outcome measure was planned to be analyzed for Part 1 and Part 2.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: E7090 1 mg With Solid Tumor | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E7090 | NA hour |
| Part 1: E7090 2 mg With Solid Tumor | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E7090 | NA hour |
| Part 1: E7090 4 mg With Solid Tumor | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E7090 | 1.51 hour |
| Part 1: E7090 8 mg With Solid Tumor | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E7090 | 2.96 hour |
| Part 1: E7090 16 mg With Solid Tumor | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E7090 | 2.01 hour |
| Part 1: E7090 30 mg With Solid Tumor | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E7090 | 3.04 hour |
| Part 1: E7090 60 mg With Solid Tumor | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E7090 | 3.00 hour |
| Part 1: E7090 100 mg With Solid Tumor | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E7090 | 4.95 hour |
| Part 1: E7090 140 mg With Solid Tumor | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E7090 | 4.88 hour |
| Part 1: E7090 180 mg With Solid Tumor | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E7090 | 3.48 hour |
| Part 2: E7090 140 mg With Gastric Cancer | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E7090 | 2.96 hour |
| Part 2: E7090 140 mg With Cholangiocarcinoma | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E7090 | 3.97 hour |