Safety of PCI-32765 in Chronic Lymphocytic Leukemia
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| ClinicalTrials.gov Identifier: NCT01105247 |
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Recruitment Status :
Completed
First Posted : April 16, 2010
Results First Posted : March 31, 2014
Last Update Posted : March 31, 2014
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Sponsor:
Pharmacyclics LLC.
Information provided by (Responsible Party):
Pharmacyclics LLC.
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Brief Summary:
The purpose of this study is to establish the safety and efficacy of orally administered PCI-32765 in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| B-cell Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma | Drug: PCI-32765 | Phase 1 Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 133 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1b/2 Fixed-dose Study of Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI-32765, in Chronic Lymphocytic Leukemia |
| Study Start Date : | May 2010 |
| Actual Primary Completion Date : | December 2012 |
| Actual Study Completion Date : | February 2013 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Ibrutinib
| Arm | Intervention/treatment |
|---|---|
| Experimental: PCI-32765 |
Drug: PCI-32765
420 mg daily or 840 mg daily |
Primary Outcome Measures :
- Number of Participants With Treatment Emergent Adverse Events (AEs) [ Time Frame: From first dose to within 30 days of last dose of PCI-32765 ]Number of participants who had experienced at least one treatment emergent AEs.
Secondary Outcome Measures :
- Food Effect Cohort Assessments [ Time Frame: Fed was assessed on either Day 8 or Day 15 and Fasted was assessed on the remaining day as cross-over design. ]Geometric mean ratio (Fed/Fasted) for PCI-32765 AUClast. The data were collected at 0, 0.5, 1, 2, 4, 6, 24 h post-dose. The AUClast was calculated from 0 up to 24 hours post-dose.
- Progression Free Survival Rate at 24 Months [ Time Frame: The median follow-up time for all treated patients are 21 month, range (0.7 month, 29 months). ]Criteria for progression are as outlined in the IWCLL 2008 criteria (Hallek 2008) and as assessed by investigator, e.g. progression defined as a 50% increase in lymph node size.
- Percentage of Participants Achieving Response [ Time Frame: The median follow-up time for all treated patients are 21 month, range (0.7 month, 29 months). ]Response criteria are as outlined in the IWCLL 2008 criteria (Hallek 2008) and as assessed by investigator, e.g. response requires 50% reduction in lymph node size.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- FOR TREATMENT-NAIVE GROUP ONLY: Men and women ≥ 65 years of age with confirmed diagnosis of CLL/SLL, who require treatment per NCI or International Working Group guidelines 15-18
- FOR RELAPSED/REFRACTORY GROUP ONLY: Men and women ≥ 18 years of age with a confirmed diagnosis of relapsed/refractory CLL/SLL following previous therapy(ie, failed ≥ 2 previous treatments for CLL/SLL and at least 1 regimen had to have had a purine analog [eg, fludarabine] for subjects with CLL)
- FOR HIGH-RISK RELAPSED/ REFRACTORYGROUP ONLY: Men and women ≥ 18 years of age with a confirmed diagnosis of relapsed/refractory CLL/SLL with suboptimal response to chemoimmunotherapy, defined as progression of disease within 24 months of initiation of a regimen containing at least a nucleoside analogue or bendamustine in combination with a monoclonal antibody or failure to respond to such a regimen. (Note: a minimum of 2 cycles of chemoimmunotherapy required for eligibility)
- ECOG performance status of ≤ 2
- Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty
Exclusion Criteria:
- Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for at least 2 years or which will not limit survival to < 2 years
- Any immunotherapy, chemotherapy, radiotherapy, or experimental therapy within 4 weeks before first dose of study drug (corticosteroids for disease-related symptoms allowed but require 1-week washout before study drug administration)
- Central nervous system (CNS) involvement by lymphoma
- Major surgery within 4 weeks before first dose of study drug
- Concomitant use of medicines known to cause QT prolongation or torsades de pointes
- Significant screening electrocardiogram (ECG) abnormalities including left bundle branch block, 2nd degree AV block type II, 3rd degree block, bradycardia, and QTc > 470 msec
- Lactating or pregnant
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01105247
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 | |
| 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 | |
Sponsors and Collaborators
Pharmacyclics LLC.
Investigators
| Study Director: | Danelle James, M.D., M.A.S | Pharmacyclics LLC. |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Pharmacyclics LLC. |
| ClinicalTrials.gov Identifier: | NCT01105247 |
| Other Study ID Numbers: |
PCYC-1102-CA PCI-32765 ( Other Identifier: Pharmacyclics ) |
| First Posted: | April 16, 2010 Key Record Dates |
| Results First Posted: | March 31, 2014 |
| Last Update Posted: | March 31, 2014 |
| Last Verified: | February 2014 |
Keywords provided by Pharmacyclics LLC.:
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PCI-32765 Lymphoma, B-Cell Leukemia, Lymphoid Leukemia, B-Cell Bruton's Tyrosine Kinase |
Additional relevant MeSH terms:
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Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia, B-Cell |