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Safety of PCI-32765 in Chronic Lymphocytic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01105247
Recruitment Status : Completed
First Posted : April 16, 2010
Results First Posted : March 31, 2014
Last Update Posted : March 31, 2014
Information provided by (Responsible Party):
Pharmacyclics LLC.

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

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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

Arm Intervention/treatment
Experimental: PCI-32765 Drug: PCI-32765
420 mg daily or 840 mg daily

Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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

Inclusion Criteria:

  1. 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
  2. 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)
  3. 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)
  4. ECOG performance status of ≤ 2
  5. Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty

Exclusion Criteria:

  1. 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
  2. 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)
  3. Central nervous system (CNS) involvement by lymphoma
  4. Major surgery within 4 weeks before first dose of study drug
  5. Concomitant use of medicines known to cause QT prolongation or torsades de pointes
  6. Significant screening electrocardiogram (ECG) abnormalities including left bundle branch block, 2nd degree AV block type II, 3rd degree block, bradycardia, and QTc > 470 msec
  7. 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

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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.
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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):

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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.:
Lymphoma, B-Cell
Leukemia, Lymphoid
Leukemia, B-Cell
Bruton's Tyrosine Kinase
Additional relevant MeSH terms:
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Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell