Multicenter Phase 2 Study of Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI-32765, in Relapsed or Refractory Mantle Cell Lymphoma
The primary objective of this trial is to evaluate the efficacy of PCI-32765 in
relapsed/refractory subjects with MCL. The secondary objective is to evaluate the safety of
a fixed daily dosing regimen of PCI-32765 capsules in this population.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To Measure the Number of Participants with a Response to Study Drug
Participants will be followed until progression of disease or start of another anti-cancer treatment.
No
Darrin Beaupre, MD, PhD
Study Director
Phramcyclics
United States: Food and Drug Administration
PCYC-1104-CA
NCT01236391
February 2011
March 2014
Name | Location |
---|---|
MD Anderson Cancer Center | Houston, Texas 77030-4096 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Stanford University School of Medicine | Stanford, California 94305-5317 |
Oregon Health & Science University | Portland, Oregon 97201 |
University of Wisconsin | Madison,, Wisconsin 53792-5666 |
New York Presbyterian Hospital/Cornell Medical Center | New York, New York 10021 |
CLL Research and Treatment Program | New Hyde Park, New York 11042 |
The Ohio Sate university | Columbus, Ohio 43210 |
University of Virginia School of Medicine Hospital | Charlottesville, Virginia 22908 |