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| Sponsor: | Pharmacyclics |
|---|---|
| Information provided by (Responsible Party): | Pharmacyclics |
| ClinicalTrials.gov Identifier: | NCT01236391 |
Purpose
The purpose of this study is to:
| Condition | Intervention | Phase |
|---|---|---|
|
Mantle Cell Lymphoma |
Drug: PCI-32765 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Multicenter Phase 2 Study of Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI-32765, in Relapsed or Refractory Mantle Cell Lymphoma |
| Estimated Enrollment: | 115 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: PCI-32765 Prior Bortezomib Treatment
PCI-32765 for patients who have failed previous bortezomib treatment
|
Drug: PCI-32765
560 mg daily
|
|
Experimental: PCI-32765 Bortezomib naive
PCI-32765 for patients who have not previously been treated with Bortezomib
|
Drug: PCI-32765
560 mg daily
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Major exclusion criteria:
Any of the following laboratory abnormalities:
Contacts and Locations| United States, California | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
| United States, New Jersey | |
| Hackensack University Medical Center | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New York | |
| Cll Research and Treatment Program | |
| New Hyde Park, New York, United States, 11042 | |
| New York Presbyterian Hospital/Cornell Medical Center | |
| New York, New York, United States, 94305 | |
| United States, Ohio | |
| The Ohio Sate university | |
| Columbus, Ohio, United States, 43210 | |
| United States, Oregon | |
| Oregon Health & Science University | |
| Portland, Oregon, United States, 97239 | |
| United States, Texas | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| United States, Virginia | |
| University of Virginia School of Medicine Hospital | |
| Charlottesville, Virginia, United States, 22908 | |
| United States, Wisconsin | |
| University of Wisconsin | |
| Madison, Wisconsin, United States, 53792 | |
| Austria | |
| Landeskrankenhaus Salzburg | |
| Salzburg, Austria, A-5020 | |
| Germany | |
| Klinikum der Universitat Munchen - Campus Grosshadern | |
| Munchen, Germany, D - 81377 | |
| Universitatsklinikum Ulm, Klinik fur Innere Medizin II | |
| ULM, Germany, 89081 | |
| Universitatsklinikum Wurzburg | |
| Wurzburg, Germany, 97080 | |
| Poland | |
| Oddzail Kliniczny Onkologil | |
| Bydgoszcz, Poland, 85-796 | |
| Malopolskie Centrum Medyczne | |
| Krakow, Poland, 30-510 | |
| MTZ Clinical Research Sp. z o.o. | |
| Warsaw, Poland, 02-106 | |
| United Kingdom | |
| Centre for Experimental Cancer Medicine | |
| London, United Kingdom, EC1M6BQ | |
| Christie Hospital | |
| Manchester, United Kingdom, M20 4BX | |
| Derriford Hospital | |
| Plymouth, United Kingdom, PL6 8DH | |
| Southampton General Hospital | |
| Southampton, United Kingdom, SO16 6YD | |
| Study Director: | Jesse McGreivy, MD | Phramcyclics |
More Information
| Responsible Party: | Pharmacyclics |
| ClinicalTrials.gov Identifier: | NCT01236391 History of Changes |
| Other Study ID Numbers: | PCYC-1104-CA, PCI-32765 |
| Study First Received: | October 18, 2010 |
| Last Updated: | April 27, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Pharmacyclics Mantle Mantle Cell Lymphoma Non-Hodgkins |
Bortezomib Velcade Naive PCYC |
|
Lymphoma Lymphoma, Mantle-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Lymphoma, Non-Hodgkin Bortezomib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |