Safety and Efficacy Study of PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01217229|
Recruitment Status : Completed
First Posted : October 8, 2010
Results First Posted : March 15, 2013
Last Update Posted : April 10, 2013
|Condition or disease||Intervention/treatment||Phase|
|Hodgkin Lymphoma||Drug: PLX3397||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Safety and Efficacy Study of Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||May 2012|
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.
- Disease Response Using Cheson Criteria [ Time Frame: 1 year ]Subjects will be monitored for response and disease progression with contrast CT/18FDG-PET scans every two cycles. Each cycle is 28 days. Response to treatment as defined by Cheson criteria will be reported via descriptive statistics. Per Cheson Criteria: Complete Response (CR) is disappearance of all evidence of disease; Partial Response (PR) 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.
- Progression Free Survival [ Time Frame: 1 Year ]Subjects will be monitored for disease progression with contrast CT/18FDG-PET scans every two cycles. One cycle is 28 days.
- Pharmacodynamic Biomarkers [ Time Frame: 1 year ]Blood samples for serum CSF-1, IL-34 and biomarkers of Fms inhibiton and Hodgkin Lymphoma activity will be obtained from subjects and analyzed for changes in activity.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01217229
|United States, California|
|UCLA Jonsson Comprehensive Cancer Center|
|Los Angeles, California, United States, 90095|
|United States, Illinois|
|Northwestern University, The Robert H Lurie Comprehensive Cancer Center|
|Chicago, Illinois, United States, 60611|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, Nebraska|
|Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|