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| Sponsor: | Pharmacyclics |
|---|---|
| Information provided by: | 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 I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Control: Uncontrolled 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: | 36 |
| Study Start Date: | February 2009 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| PCI-32765: Experimental |
Drug: PCI-32765
PCI-32765 will be administered in 1.25, 2.5, 5.0, 8.3, 12.5, and 17.5 mg/kg/d dose cohorts orally once per day for 28 days followed by a 7 day rest period. Six patients will be enrolled in each dosing cohort. If ≥ 2 DLTs occur in any cohort, the MTD will be established as the previous dosing cohort. If MTD is not reached, dosing levels may be increased beyond 17.5 mg/kg/d by 33% increments. The study will continue until the MTD has been established. Patients who do not experience DLT during Cycle 1 may continue with additional cycles of 28 day PCI-32765 treatment followed by a 7 day rest period for a maximum of six cycles provided that there is no disease progression or DLT.
|
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| Contact: Sara Rodriguez | 408-215-3455 | srodriguez@pcyc.com |
| Contact: Raquel Izumi, PhD | 408-215-3341 | rizumi@pcyc.com |
| United States, Arizona | |
| TGen Clinical Research Services at Scottsdale Healthcare | Terminated |
| Scottsdale, Arizona, United States, 85258 | |
| United States, California | |
| Stanford University School of Medicine | Recruiting |
| Palo Alto, California, United States, 94305 | |
| Contact: Sipra Choudhury 650-736-2563 schoudhury@stanford.edu | |
| Principal Investigator: Ranjana Advani, MD | |
| United States, Illinois | |
| University of Chicago | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: Angela Cisneros 773-834-0475 acisnero@medicine.bsd.uchicago.edu | |
| Principal Investigator: Sonali Smith, MD | |
| United States, Maryland | |
| National Cancer Institute | Recruiting |
| Bethesda, Maryland, United States, 20892-1203 | |
| Contact: Therese White 301-402-5886 whiteth@mail.nih.gov | |
| Principal Investigator: Wyndham Wilson, MD | |
| United States, New York | |
| New York Prebyterian Hospital Cornell Medical Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Julia Morrison 212-746-5269 jum2020@med.cornell.edu | |
| Principal Investigator: Richard Furman, MD | |
| United States, Oregon | |
| Willamette Valley Cancer Institute/Research Ctr | Recruiting |
| Eugene, Oregon, United States, 97401 | |
| Contact: Jeanne Schaffer 541-683-5001 jeanne.schaffer@usoncology.com | |
| Principal Investigator: Jeff P Sharman, MD | |
| United States, Texas | |
| University of Texas, MD Anderson | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Justin Cummings 713-792-8785 jjcummings@mdanderson.org | |
| Principal Investigator: Nathan Fowler, MD | |
| United States, Vermont | |
| University of Vermont College of Medicine | Recruiting |
| Burlington, Vermont, United States, 05405 | |
| Contact: Karen Lepsuchenko 802-656-9924 lepuschenko@uvm.edu | |
| Principal Investigator: Barbara Grant, MD | |
| United States, Virginia | |
| Virginia Oncology Associates | Recruiting |
| Norfolk, Virginia, United States, 23502 | |
| Contact: Tracy Harding, RN 757-213-5658 tracy.harding@usoncology.com | |
| Principal Investigator: Paul Conkling, MD | |
| United States, Washington | |
| Northwest Cancer Specialists, Vancouver Cancer Center | Recruiting |
| Vancouver, Washington, United States, 98684 | |
| Contact: Judy Welch, RN 360-449-6522 judith.welch@usoncology.com | |
| Principal Investigator: Kate Kolibaba, MD | |
| Yakima Valley Memorial Hospital/North Star Lodge Cancer Ctr | Recruiting |
| Yakima, Washington, United States, 98902 | |
| Contact: Beth Parker, CRC 509-574-3493 bethparker@yvmh.org | |
| Principal Investigator: Thomas Boyd, MD | |
| Study Director: | Ahmed Hamdy, MD | Pharmacyclics |
More Information
| Responsible Party: | Pharmacyclics ( Ahmed Hamdy, MD ) |
| ClinicalTrials.gov Identifier: | NCT00849654 History of Changes |
| Other Study ID Numbers: | PCYC-04753 |
| Study First Received: | February 20, 2009 |
| Last Updated: | July 27, 2010 |
| 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 |