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| Sponsor: | Pharmacyclics |
|---|---|
| Information provided by (Responsible Party): | Pharmacyclics |
| ClinicalTrials.gov Identifier: | NCT01105247 |
Purpose
The purpose of this study is to establish the safety and optimal dose of orally administered PCI-32765 in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
B-cell Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Diffuse Well-differentiated Lymphocytic Lymphoma |
Drug: PCI-32765 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1b Fixed-dose Study of Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI-32765, in Chronic Lymphocytic Leukemia |
| Estimated Enrollment: | 72 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: PCI-32765 |
Drug: PCI-32765
420 mg daily
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
| United States, New York | |
| New York Presbyterian Hosptial Cornell Med Center | |
| New York, New York, United States, 10065 | |
| United States, Ohio | |
| The Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| Dayton Oncology & Hematology | |
| Kettering, Ohio, United States, 45409 | |
| United States, Oregon | |
| Willamette Valley Cancer Institute and Research Center | |
| Springfield, Oregon, United States, 97477 | |
| United States, Tennessee | |
| Sarah Cannon | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Texas Oncology - Tyler | |
| Tyler, Texas, United States, 75702 | |
| United States, Vermont | |
| University of Vermont and Fletcher Allen Health Care | |
| Burlington, Vermont, United States, 05405 | |
| United States, Washington | |
| Northwest Cancer Specialists, P.C. | |
| Vancouver, Washington, United States, 98686 | |
| Yakima Valley Memorial | |
| Yakima, Washington, United States, 98902 | |
| Study Director: | Danelle James, M.D., M.A.S | Pharmacyclics |
More Information
| Responsible Party: | Pharmacyclics |
| ClinicalTrials.gov Identifier: | NCT01105247 History of Changes |
| Other Study ID Numbers: | PCYC-1102-CA, PCI-32765 |
| Study First Received: | April 13, 2010 |
| Last Updated: | February 23, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
|
PCI-32765 Lymphoma, B-Cell Leukemia, Lymphoid Leukemia, B-Cell Bruton's Tyrosine Kinase |
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphoma Neoplasms by Histologic Type Neoplasms |
Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |