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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
UCLA Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Northwestern University, The Robert H Lurie Comprehensive Cancer Center
Chicago, Illinois, United States
Mayo Clinic
Rochester, Minnesota, United States
Nebraska Medical Center
Omaha, Nebraska, United States
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
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
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
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
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Memorial Sloan-Kettering Cancer Center
New York, New York, United States
MD Anderson Cancer Center
Houston, Texas, United States