Hodgkin Lymphoma
Conditions
Keywords
Hodgkin Lymphoma
Brief summary
PLX3397 is a selective inhibitor of Fms, Kit, and oncogenic Flt3 activity.The primary objective of this study is to evaluate the efficacy, as measured by overall response rate, of orally administered PLX3397 in patients with relapsed or refractory classical Hodgkin lymphoma (HL). Secondary objectives include safety, the duration of response, the disease control rate, progression free survival, and how the drug affects your body.
Interventions
DRUGPLX3397
Capsules administered once or twice daily, continuous dosing. Subjects will begin with 900 mg/day, but should safety data allow in our PLX108-01 study, subject may dose at 1200 mg/day.
Sponsors
Plexxikon
Daiichi Sankyo
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
1. Male or female patients ≥18 years old 2. Pathologic confirmation of relapsed or refractory classical Hodgkin lymphoma, with archival or fresh tissue available for retrospective analysis. 3. Patients must have progressed after-or been ineligible for-autologous stem cell transplantation. Patients who received a prior allogeneic stem cell transplantation are eligible if they have no evidence of graft versus host disease (GVHD) and have been off immunosuppression for at least 3 months prior to Cycle 1 Day 1 (C1D1). 4. Documented disease that is radiographically measurable (≥2 cm in the largest transverse dimension). 5. Patients must have discontinued any previous monoclonal antibody, radioimmunotherapy, or cytotoxic chemotherapy at least 28 days prior to C1D1 and must have recovered fully from the side effects of that treatment prior to beginning study treatment. 6. Women of child-bearing potential must have a negative pregnancy test within 7 days of initiation of dosing and must agree to use an acceptable method of birth control while on study drug and for 3 months after the last dose. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥1 year. Men of child-bearing potential must also agree to use an acceptable method of birth control while on study drug. 7. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 8. Adequate hematologic, hepatic, and renal function (absolute neutrophil count ≥1.0 x 109/L, Hgb \>9 g/dL, platelet count ≥50 x 109/L, Aspartate Transaminase (AST) / Alanine Transaminase (ALT) ≤2.5x Upper limit of normal (ULN), creatinine ≤1.5x ULN) 9. Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements
Exclusion criteria
1. Investigational drug use within 28 days of the first dose of PLX3397 2. History or clinical evidence of central nervous system, meningeal, or epidural disease including brain metastasis 3. Patients with another active cancer \[excluding basal cell carcinoma or cervical intraepithelial neoplasia (cervical carcinoma in situ) or melanoma in situ\]. Prior history of other cancer is allowed, as long as there was no active disease within the prior 5 years. 4. Patients with uncontrolled intercurrent illness, an active or uncontrolled infection, or a fever \>38.5˚C (not due to tumor fever) on C1D1 5. Refractory nausea and vomiting, malabsorption, biliary shunt, or significant bowel resection that would preclude adequate absorption 6. Patients with serious illnesses, medical conditions, or other medical history including abnormal laboratory results, which in the investigator's opinion would be likely to interfere with a patient's participation in the study, or with the interpretation of the results 7. Women of child-bearing potential who are pregnant or breast feeding 8. Corrected QT interval (QTc) ≥450 msec.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival According to the Cheson Criteria by Kaplan-Meier Analysis Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population) | Baseline to 1 year postdose | Progression-free survival was assessed by Kaplan Meier analysis and was defined as the number of days from the first day of treatment to the date of first documented disease progression or date of death (whichever occurred first). |
| Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population) | Baseline to Cycles 3, 5, 7, 10, and 13, up to 1 year postdose | Subjects were monitored for response and disease progression with contrast Computed tomography (CT) /18Fluorodeoxyglucose (FDG)-positron emission tomography (PET) scans every two cycles. Each cycle is 28 days. Response to treatment as defined by Cheson criteria was reported via descriptive statistics. Target tumor response is Complete Response (CR) + Partial Response (PR) and target tumor disease control rate (CR + PR + Stable Disease (SD)) are reported. Per Cheson Criteria, CR is disappearance of all evidence of disease; Partial Response is regression of measurable disease and no new sites (≥50% decrease in sum of product diameters of up to 6 largest dominant masses and splenic/liver nodules), and no increase in size of other nodes/liver/spleen; reduction in target lesions, no growth of non-target or new lesions; Progression is any new lesion or increase by ≥50% of previously involved sites from the nadir. |
| Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population) | Baseline to 1 year post-dose | — |
| Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population) | Baseline to 1 year postdose | Grade 2 adverse events were defined as events that were moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). |
Countries
United States
Participant flow
Recruitment details
A total of 20 participants who met all inclusion and no exclusion criteria were enrolled and received treatment at 6 clinic sites in the United States.
Participants by arm
| Arm | Count |
|---|---|
| PLX3397 Participants received PLX3397 administered once or twice daily with continuous dosing at 900 mg/day. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Disease progression, Cheson criteria | 14 |
| Overall Study | Disease progression, deterioration | 2 |
| Overall Study | Disease progression not confirmed | 2 |
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | PLX3397 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Age, Continuous | 40.9 years STANDARD_DEVIATION 19.05 |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 20 / 20 |
| serious Total, serious adverse events | 1 / 20 |
Outcome results
Primary
Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population)
Grade 2 adverse events were defined as events that were moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL).
Time frame: Baseline to 1 year postdose
Population: Adverse events were assessed in the Safety Analysis population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PLX3397 | Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population) | Grade 2 Squamous cell carcinoma | 1 Participants |
| PLX3397 | Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population) | Grade 3 Syncope | 1 Participants |
| PLX3397 | Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population) | At least 1 Grade 2 adverse event | 13 Participants |
| PLX3397 | Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population) | At least 1 Grade 3 adverse event | 5 Participants |
| PLX3397 | Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population) | Grade 2 Anaemia | 6 Participants |
| PLX3397 | Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population) | Grade 2 Neutropenia | 1 Participants |
| PLX3397 | Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population) | Grade 3 Neutropenia | 1 Participants |
| PLX3397 | Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population) | Grade 2 Thrombocytopenia | 1 Participants |
| PLX3397 | Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population) | Grade 3 Thrombocytopenia | 1 Participants |
| PLX3397 | Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population) | Grade 2 Fatigue | 5 Participants |
| PLX3397 | Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population) | Grade 2 Pyrexia | 2 Participants |
| PLX3397 | Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population) | Grade 3 Lung infection | 1 Participants |
| PLX3397 | Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population) | Grade 2 Pneumonia | 1 Participants |
| PLX3397 | Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population) | Grade 3 Blood alkaline phosphatase | 1 Participants |
| PLX3397 | Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population) | Grade 2 Blood lactate dehydrogenase increased | 2 Participants |
| PLX3397 | Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population) | Grade 3 Neutrophil count decreased | 3 Participants |
| PLX3397 | Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population) | Grade 2 Decreased appetite | 1 Participants |
| PLX3397 | Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population) | Grade 2 Muscular weakness | 1 Participants |
| PLX3397 | Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population) | Grade 2 Anxiety | 1 Participants |
| PLX3397 | Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population) | Grade 2 Dyspnoea | 2 Participants |
| PLX3397 | Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population) | Grade 2 Erythema multiforme | 1 Participants |
| PLX3397 | Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population) | Grade 2 Rash | 2 Participants |
| PLX3397 | Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population) | Grade 3 Rash | 1 Participants |
| PLX3397 | Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population) | Grade 2 Skin exfoliation | 1 Participants |
Primary
Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population)
Time frame: Baseline to 1 year post-dose
Population: Adverse events were assessed in the Safety Analysis population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PLX3397 | Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population) | Vomiting | 2 Participants |
| PLX3397 | Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population) | Chills | 2 Participants |
| PLX3397 | Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population) | Fatigue | 8 Participants |
| PLX3397 | Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population) | Pyrexia | 4 Participants |
| PLX3397 | Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population) | Dyspnoea | 5 Participants |
| PLX3397 | Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population) | At least 1 adverse event | 20 Participants |
| PLX3397 | Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population) | Anaemia | 6 Participants |
| PLX3397 | Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population) | Thrombocytopenia | 6 Participants |
| PLX3397 | Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population) | Diarrhoea | 2 Participants |
| PLX3397 | Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population) | Nausea | 2 Participants |
| PLX3397 | Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population) | Aspartate aminotransferase increased | 2 Participants |
| PLX3397 | Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population) | Blood lactate dehydrogenase increased | 5 Participants |
| PLX3397 | Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population) | Decreased appetite | 3 Participants |
| PLX3397 | Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population) | Back pain | 2 Participants |
| PLX3397 | Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population) | Dizziness | 2 Participants |
| PLX3397 | Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population) | Headache | 2 Participants |
| PLX3397 | Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population) | Cough | 3 Participants |
| PLX3397 | Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population) | Productive cough | 2 Participants |
| PLX3397 | Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population) | Hair colour changes | 8 Participants |
| PLX3397 | Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population) | Rash | 5 Participants |
Primary
Progression-Free Survival According to the Cheson Criteria by Kaplan-Meier Analysis Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)
Progression-free survival was assessed by Kaplan Meier analysis and was defined as the number of days from the first day of treatment to the date of first documented disease progression or date of death (whichever occurred first).
Time frame: Baseline to 1 year postdose
Population: Progression-free survival was assessed in the Modified Intent-to-Treat population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PLX3397 | Progression-Free Survival According to the Cheson Criteria by Kaplan-Meier Analysis Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population) | 56 days |
Primary
Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)
Subjects were monitored for response and disease progression with contrast Computed tomography (CT) /18Fluorodeoxyglucose (FDG)-positron emission tomography (PET) scans every two cycles. Each cycle is 28 days. Response to treatment as defined by Cheson criteria was reported via descriptive statistics. Target tumor response is Complete Response (CR) + Partial Response (PR) and target tumor disease control rate (CR + PR + Stable Disease (SD)) are reported. Per Cheson Criteria, CR is disappearance of all evidence of disease; Partial Response is regression of measurable disease and no new sites (≥50% decrease in sum of product diameters of up to 6 largest dominant masses and splenic/liver nodules), and no increase in size of other nodes/liver/spleen; reduction in target lesions, no growth of non-target or new lesions; Progression is any new lesion or increase by ≥50% of previously involved sites from the nadir.
Time frame: Baseline to Cycles 3, 5, 7, 10, and 13, up to 1 year postdose
Population: Tumor response was assessed in the Modified Intent-to-Treat population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PLX3397 | Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population) | Overall: Target tumor response (CR+PR) | 1 Participants |
| PLX3397 | Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population) | Overall: Target tumor DCR (CR+PR+SD) | 4 Participants |
| PLX3397 | Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population) | Overall: Complete response (CR) | 0 Participants |
| PLX3397 | Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population) | Overall: Partial response (PR) | 1 Participants |
| PLX3397 | Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population) | Overall: Stable disease (SD) | 3 Participants |
| PLX3397 | Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population) | Overall: Relapsed disease or progressive disease | 13 Participants |
| PLX3397 | Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population) | Cycle 3: Target tumor response (CR+PR) | 0 Participants |
| PLX3397 | Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population) | Cycle 3: Target tumor DCR (CR+PR+SD) | 4 Participants |
| PLX3397 | Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population) | Cycle 3: Complete response (CR) | 0 Participants |
| PLX3397 | Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population) | Cycle 3: Partial response (PR) | 0 Participants |
| PLX3397 | Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population) | Cycle 3: Stable disease (SD) | 4 Participants |
| PLX3397 | Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population) | Cycle 3: Relapsed disease or progressive disease | 1 Participants |
| PLX3397 | Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population) | Cycle 5: Target tumor response (CR+PR) | 0 Participants |
| PLX3397 | Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population) | Cycle 5: Target tumor DCR (CR+PR+SD) | 1 Participants |
| PLX3397 | Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population) | Cycle 5: Complete response (CR) | 0 Participants |
| PLX3397 | Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population) | Cycle 5: Partial response (PR) | 0 Participants |
| PLX3397 | Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population) | Cycle 5: Stable disease (SD) | 1 Participants |
| PLX3397 | Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population) | Cycle 5: Relapsed disease or progressive disease | 0 Participants |
| PLX3397 | Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population) | Cycle 7: Target tumor response (CR+PR) | 1 Participants |
| PLX3397 | Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population) | Cycle 7: Target tumor DCR (CR+PR+SD) | 1 Participants |
| PLX3397 | Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population) | Cycle 7: Complete response (CR) | 0 Participants |
| PLX3397 | Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population) | Cycle 7: Partial response (PR) | 1 Participants |
| PLX3397 | Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population) | Cycle 7: Stable disease (SD) | 0 Participants |
| PLX3397 | Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population) | Cycle 7: Relapsed disease or progressive disease | 0 Participants |
| PLX3397 | Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population) | Cycle 10: Target tumor response (CR+PR) | 1 Participants |
| PLX3397 | Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population) | Cycle 10: Target tumor DCR (CR+PR+SD) | 1 Participants |
| PLX3397 | Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population) | Cycle 10: Complete response (CR) | 0 Participants |
| PLX3397 | Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population) | Cycle 10: Partial response (PR) | 1 Participants |
| PLX3397 | Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population) | Cycle 10: Stable disease (SD) | 0 Participants |
| PLX3397 | Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population) | Cycle 10: Relapsed disease or progressive disease | 0 Participants |
| PLX3397 | Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population) | Cycle 13: Target tumor response (CR+PR) | 1 Participants |
| PLX3397 | Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population) | Cycle 13: Target tumor DCR (CR+PR+SD) | 1 Participants |
| PLX3397 | Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population) | Cycle 13: Complete response (CR) | 0 Participants |
| PLX3397 | Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population) | Cycle 13: Partial response (PR) | 1 Participants |
| PLX3397 | Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population) | Cycle 13: Stable disease (SD) | 0 Participants |
| PLX3397 | Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population) | Cycle 13: Relapsed disease or progressive disease | 0 Participants |