- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01217229
Safety and Efficacy Study of PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma
June 18, 2020 updated by: Daiichi Sankyo, Inc.
A Phase 2 Safety and Efficacy Study of Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma
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 Overview
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States, 90095
- UCLA Jonsson Comprehensive Cancer Center
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University, The Robert H Lurie Comprehensive Cancer Center
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Nebraska
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Omaha, Nebraska, United States, 68198
- Nebraska Medical Center
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New York
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New York, New York, United States, 10065
- Memorial Sloan-Kettering Cancer Center
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Texas
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Houston, Texas, United States, 77030
- MD Anderson Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female patients ≥18 years old
- Pathologic confirmation of relapsed or refractory classical Hodgkin lymphoma, with archival or fresh tissue available for retrospective analysis.
- 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).
- Documented disease that is radiographically measurable (≥2 cm in the largest transverse dimension).
- 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.
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- 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)
- Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements
Exclusion Criteria:
- Investigational drug use within 28 days of the first dose of PLX3397
- History or clinical evidence of central nervous system, meningeal, or epidural disease including brain metastasis
- 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.
- Patients with uncontrolled intercurrent illness, an active or uncontrolled infection, or a fever >38.5˚C (not due to tumor fever) on C1D1
- Refractory nausea and vomiting, malabsorption, biliary shunt, or significant bowel resection that would preclude adequate absorption
- 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
- Women of child-bearing potential who are pregnant or breast feeding
- Corrected QT interval (QTc) ≥450 msec.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: PLX3397
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
Time Frame: Baseline to 1 year postdose
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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).
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Baseline to 1 year postdose
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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)
Time Frame: Baseline to Cycles 3, 5, 7, 10, and 13, up to 1 year postdose
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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.
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Baseline to Cycles 3, 5, 7, 10, and 13, up to 1 year postdose
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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
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Baseline to 1 year post-dose
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Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population)
Time Frame: Baseline to 1 year postdose
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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).
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Baseline to 1 year postdose
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 3, 2011
Primary Completion (ACTUAL)
April 26, 2012
Study Completion (ACTUAL)
April 26, 2012
Study Registration Dates
First Submitted
October 4, 2010
First Submitted That Met QC Criteria
October 6, 2010
First Posted (ESTIMATE)
October 8, 2010
Study Record Updates
Last Update Posted (ACTUAL)
June 30, 2020
Last Update Submitted That Met QC Criteria
June 18, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PLX108-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/.
In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants.
Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
IPD Sharing Time Frame
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
IPD Sharing Access Criteria
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research.
This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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National Cancer Institute (NCI)CompletedRecurrent Adult Hodgkin Lymphoma | Stage III Adult Hodgkin Lymphoma | Stage IV Adult Hodgkin Lymphoma | Recurrent/Refractory Childhood Hodgkin Lymphoma | Stage III Childhood Hodgkin Lymphoma | Stage IV Childhood Hodgkin Lymphoma | Stage I Adult Hodgkin Lymphoma | Stage I Childhood Hodgkin Lymphoma | Stage II Adult Hodgkin Lymphoma and other conditionsUnited States
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Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)Active, not recruitingAnn Arbor Stage III Hodgkin Lymphoma | Ann Arbor Stage IIIA Hodgkin Lymphoma | Ann Arbor Stage IIIB Hodgkin Lymphoma | Ann Arbor Stage IV Hodgkin Lymphoma | Ann Arbor Stage IVA Hodgkin Lymphoma | Ann Arbor Stage IVB Hodgkin Lymphoma | Classic Hodgkin Lymphoma | Ann Arbor Stage IB Hodgkin Lymphoma | Ann... and other conditionsUnited States
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National Cancer Institute (NCI)CompletedRecurrent Adult Hodgkin Lymphoma | Adult Lymphocyte Depletion Hodgkin Lymphoma | Adult Lymphocyte Predominant Hodgkin Lymphoma | Adult Mixed Cellularity Hodgkin Lymphoma | Adult Nodular Sclerosis Hodgkin Lymphoma | Adult Nodular Lymphocyte Predominant Hodgkin Lymphoma | Adult Favorable Prognosis... and other conditionsUnited States
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)TerminatedRecurrent Hodgkin Lymphoma | Refractory Hodgkin Lymphoma | Refractory B-Cell Non-Hodgkin Lymphoma | Refractory T-Cell Non-Hodgkin Lymphoma | Recurrent B-Cell Non-Hodgkin Lymphoma | Recurrent T-Cell Non-Hodgkin LymphomaUnited States
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedRecurrent Hodgkin Lymphoma | Refractory Hodgkin Lymphoma | Recurrent Mantle Cell Lymphoma | Refractory B-Cell Non-Hodgkin Lymphoma | Refractory T-Cell Non-Hodgkin Lymphoma | Recurrent B-Cell Non-Hodgkin Lymphoma | Recurrent T-Cell Non-Hodgkin Lymphoma | Refractory Mantle Cell LymphomaUnited States
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Children's Oncology GroupNational Cancer Institute (NCI)CompletedStage III Childhood Hodgkin Lymphoma | Stage IV Childhood Hodgkin Lymphoma | Stage I Childhood Hodgkin Lymphoma | Stage II Childhood Hodgkin Lymphoma | Childhood Nodular Lymphocyte Predominant Hodgkin Lymphoma | Childhood Lymphocyte-Depleted Classical Hodgkin Lymphoma | Childhood Mixed Cellularity... and other conditionsUnited States, Canada, Australia, New Zealand, Puerto Rico, Switzerland, Israel
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Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)Active, not recruitingClassic Hodgkin Lymphoma | Ann Arbor Stage IB Hodgkin Lymphoma | Ann Arbor Stage II Hodgkin Lymphoma | Ann Arbor Stage IIA Hodgkin Lymphoma | Ann Arbor Stage IIB Hodgkin Lymphoma | Ann Arbor Stage I Hodgkin Lymphoma | Ann Arbor Stage IA Hodgkin LymphomaUnited States
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Northwestern UniversitySeagen Inc.; Robert H. Lurie Cancer CenterUnknownStage III Adult Hodgkin Lymphoma | Stage IV Adult Hodgkin Lymphoma | Stage II Adult Hodgkin Lymphoma | Adult Lymphocyte Depletion Hodgkin Lymphoma | Adult Lymphocyte Predominant Hodgkin Lymphoma | Adult Mixed Cellularity Hodgkin Lymphoma | Adult Nodular Sclerosis Hodgkin LymphomaUnited States
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National Cancer Institute (NCI)Active, not recruitingAnn Arbor Stage IIIB Hodgkin Lymphoma | Ann Arbor Stage IVA Hodgkin Lymphoma | Ann Arbor Stage IVB Hodgkin Lymphoma | Classic Hodgkin Lymphoma | Ann Arbor Stage IIB Hodgkin Lymphoma | Childhood Hodgkin LymphomaUnited States, Canada, Puerto Rico
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