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| Sponsor: | Pharmacyclics |
|---|---|
| Information provided by (Responsible Party): | Pharmacyclics |
| ClinicalTrials.gov Identifier: | NCT00849654 |
Purpose
The purpose of this study is to establish the safety and optimal dose of orally administered PCI-32765 in patients with recurrent B cell lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
B-Cell Lymphoma B-Cell Leukemia |
Drug: PCI-32765 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Dose-Escalation Study of Bruton's Tyrosine Kinase (Btk) Inhibitor PCI-32765 in Recurrent B Cell Lymphoma |
| Estimated Enrollment: | 75 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: PCI-32765 |
Drug: PCI-32765
In the dose-escalation cohorts, PCI-32765 will be administered in 1.25, 2.5, 5.0, 8.3, 12.5, and 17.5 mg/kg/d dose orally once per day for 28 days followed by a 7-day rest period to determine the MTD. If MTD is not reached, dosing levels may be increased beyond 17.5mg/kg/d by 33% increments. In the continuous dosing cohorts, PCI-32765 will be administered in 8.3 mg/kg/day and 560 mg/day (fixed dose) dose orally once per day for 35 days. |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Laboratory abnormalities:
Contacts and Locations| United States, Arizona | |
| TGen Clinical Research Services at Scottsdale Healthcare | |
| Scottsdale, Arizona, United States, 85258 | |
| United States, California | |
| Stanford University School of Medicine | |
| Palo Alto, California, United States, 94305 | |
| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| United States, Maryland | |
| National Cancer Institute | |
| Bethesda, Maryland, United States, 20892-1203 | |
| United States, New York | |
| New York Prebyterian Hospital Cornell Medical Center | |
| New York, New York, United States, 10065 | |
| United States, Oregon | |
| Willamette Valley Cancer Institute/Research Ctr | |
| Eugene, Oregon, United States, 97401 | |
| United States, Texas | |
| University of Texas, MD Anderson | |
| Houston, Texas, United States, 77030 | |
| United States, Vermont | |
| University of Vermont College of Medicine | |
| Burlington, Vermont, United States, 05405 | |
| United States, Washington | |
| Northwest Cancer Specialists, Vancouver Cancer Center | |
| Vancouver, Washington, United States, 98684 | |
| Yakima Valley Memorial Hospital/North Star Lodge Cancer Ctr | |
| Yakima, Washington, United States, 98902 | |
| Study Director: | Eric Hendrick, MD | Pharmacyclics |
More Information
| Responsible Party: | Pharmacyclics |
| ClinicalTrials.gov Identifier: | NCT00849654 History of Changes |
| Obsolete Identifiers: | NCT01177878 |
| Other Study ID Numbers: | PCYC-04753 |
| Study First Received: | February 20, 2009 |
| Last Updated: | March 2, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
PCI-32765 Lymphoma Lymphoma, Non-Hodgkin Lymphoma, B-Cell Burkitt Lymphoma Lymphoma, B-Cell, Marginal Zone Lymphoma, B-Cell, Diffuse |
Lymphoma, Follicular Lymphoma, Mantle Cell Leukemia, Lymphoid Leukemia, B-Cell Waldenstrom macroglobulinemia Bruton's Tyrosine Kinase |
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-Cell Lymphoma Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms |
Leukemia, Lymphoid Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |