NCT01105247CompletedPhase 1
A Phase 1b/2 Fixed-dose Study of Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI-32765, in Chronic Lymphocytic Leukemia
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Pharmacyclics LLC.
- Enrollment
- 133
- Locations
- 10
- Primary Endpoint
- Number of Participants With Treatment Emergent Adverse Events (AEs)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
PCI-32765
Experimental
Intervention: PCI-32765 (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- Food Effect Cohort Assessments(Fed was assessed on either Day 8 or Day 15 and Fasted was assessed on the remaining day as cross-over design.)
- Progression Free Survival Rate at 24 Months(The median follow-up time for all treated patients are 21 month, range (0.7 month, 29 months).)
- Percentage of Participants Achieving Response(The median follow-up time for all treated patients are 21 month, range (0.7 month, 29 months).)
Investigators
Study Sites (10)
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