Trial record 1 of 1 for:    nct01105247
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Safety of PCI-32765 in Chronic Lymphocytic Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pharmacyclics
ClinicalTrials.gov Identifier:
NCT01105247
First received: April 13, 2010
Last updated: February 13, 2014
Last verified: February 2014

April 13, 2010
February 13, 2014
May 2010
December 2012   (final data collection date for primary outcome measure)
Number of Participants With Treatment Emergent Adverse Events (AEs) [ Time Frame: From first dose to within 30 days of last dose of PCI-32765 ] [ Designated as safety issue: Yes ]
Number of participants who had experienced at least one treatment emergent AEs.
Safety and tolerability of PCI-32765 [ Time Frame: 30 days after last dose of study drug ] [ Designated as safety issue: Yes ]
frequency, severity, and relatedness of adverse events (AEs)
Complete list of historical versions of study NCT01105247 on ClinicalTrials.gov Archive Site
  • 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. ] [ Designated as safety issue: No ]
    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). ] [ Designated as safety issue: No ]
    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). ] [ Designated as safety issue: No ]
    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.
  • Pharmacokinetic/ Pharmacodynamic assessments [ Time Frame: during 1 cycle = 28 days ] [ Designated as safety issue: No ]
    Designated as safety issuePharmacodynamics of PCI-32765 (ie, drug occupancy of Btk and effect on biological markers of B cell function) Pharmacokinetics (Cmax, AUC, Tmax, and t1/2) of PCI-32765 and a major metabolite (PCI-45227)
  • Tumor response [ Time Frame: at the end of Cycles 2, 4, and 6 - ( 28 days for each cycle) ] [ Designated as safety issue: No ]
    Overall response rate as defined by recent guidelines on CLL and SLL (B cell lymphoma) Duration of response
Not Provided
Not Provided
 
Safety of PCI-32765 in Chronic Lymphocytic Leukemia
A Phase 1b/2 Fixed-dose Study of Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI-32765, in Chronic Lymphocytic Leukemia

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • B-cell Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
Drug: PCI-32765
420 mg daily or 840 mg daily
Experimental: PCI-32765
Intervention: Drug: PCI-32765

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
133
February 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01105247
PCYC-1102-CA, PCI-32765
No
Pharmacyclics
Pharmacyclics
Not Provided
Study Director: Danelle James, M.D., M.A.S Pharmacyclics
Pharmacyclics
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP