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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01105247
Other study ID # PCYC-1102-CA
Secondary ID PCI-32765
Status Completed
Phase Phase 1/Phase 2
First received April 13, 2010
Last updated February 13, 2014
Start date May 2010
Est. completion date February 2013

Study information

Verified date February 2014
Source Pharmacyclics
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 133
Est. completion date February 2013
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
PCI-32765
420 mg daily or 840 mg daily

Locations

Country Name City State
United States University of Vermont and Fletcher Allen Health Care Burlington Vermont
United States The Ohio State University Columbus Ohio
United States MD Anderson Cancer Center Houston Texas
United States Sarah Cannon Nashville Tennessee
United States New York Presbyterian Hosptial Cornell Med Center New York New York
United States Willamette Valley Cancer Institute and Research Center Springfield Oregon
United States Stanford University School of Medicine Stanford California
United States Texas Oncology - Tyler Tyler Texas
United States Northwest Cancer Specialists, P.C. Vancouver Washington
United States Yakima Valley Memorial Yakima Washington

Sponsors (1)

Lead Sponsor Collaborator
Pharmacyclics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Treatment Emergent Adverse Events (AEs) Number of participants who had experienced at least one treatment emergent AEs. From first dose to within 30 days of last dose of PCI-32765 Yes
Secondary Food Effect Cohort Assessments 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. Fed was assessed on either Day 8 or Day 15 and Fasted was assessed on the remaining day as cross-over design. No
Secondary Progression Free Survival Rate at 24 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. The median follow-up time for all treated patients are 21 month, range (0.7 month, 29 months). No
Secondary Percentage of Participants Achieving Response 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. The median follow-up time for all treated patients are 21 month, range (0.7 month, 29 months). No
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Recruiting NCT03516617 - Acalabrutinib With or Without Obinutuzumab in Treating Patients With Early-Stage Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Phase 2
Active, not recruiting NCT03336333 - A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL Phase 3
Completed NCT01973387 - A Study of PCI-32765 (Ibrutinib) Versus Rituximab in Relapsed or Refractory Chronic Leukemia/Lymphoma Phase 3

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