Safety and Efficacy of PCI-32765 in Participants With Relapsed/Refractory Mantle Cell Lymphoma (MCL) (PCYC-1104-CA)
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ClinicalTrials.gov Identifier: NCT01236391 |
Recruitment Status :
Completed
First Posted : November 8, 2010
Results First Posted : March 13, 2015
Last Update Posted : August 28, 2015
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Sponsor:
Pharmacyclics LLC.
Collaborator:
Janssen Pharmaceuticals
Information provided by (Responsible Party):
Pharmacyclics LLC.
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Tracking Information | ||||
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First Submitted Date ICMJE | October 18, 2010 | |||
First Posted Date ICMJE | November 8, 2010 | |||
Results First Submitted Date ICMJE | February 12, 2015 | |||
Results First Posted Date ICMJE | March 13, 2015 | |||
Last Update Posted Date | August 28, 2015 | |||
Study Start Date ICMJE | February 2011 | |||
Actual Primary Completion Date | January 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Percentage of Participants Achieving Response [ Time Frame: The median follow-up time on study for all treated participants is 15.3 (range 1.9 - 22.3) months ] The primary endpoint of the study was overall response rate (ORR), defined as the proportion of participants who achieved a best overall response of complete response (CR) or partial response (PR), according to the revised International Working Group Criteria for non-Hodgkin's lymphoma (Cheson et al, 2007), as assessed by the investigator. CR is a complete disappearance of all disease, no new lesions, lymph nodes must have regressed and be PET negative, spleen and liver should not be palpable and without nodules, and bone marrow must be negative. PR is a >/= 50% decrease in the sum of the product of diameters of the target lesions, and >/= 50% decrease of splenic and hepatic nodules from baseline, no new lesions and no increase in the size of liver, spleen or non-target lesions.
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Original Primary Outcome Measures ICMJE |
To Measure the Number of Participants with a Response to Study Drug [ Time Frame: Participants will be followed until progression of disease or start of another anti-cancer treatment. ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Safety and Efficacy of PCI-32765 in Participants With Relapsed/Refractory Mantle Cell Lymphoma (MCL) | |||
Official Title ICMJE | Multicenter Phase 2 Study of Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI-32765, in Relapsed or Refractory Mantle Cell Lymphoma | |||
Brief Summary | The primary objective of this study was to evaluate the efficacy of ibrutinib in participants with relapsed or refractory MCL. The secondary objective was to evaluate the safety of a fixed daily dosing regimen (560 mg daily) of PCI-32765 in this population. |
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Detailed Description | This is a Phase 2, open-label, nonrandomized, multicenter, monotherapy study in subjects with histologically documented MCL who have relapsed after ≥ 1 (but not > 5) prior treatment regimens. All subjects meeting eligibility criteria will receive PCI-32765 capsules at a dosage of 560 mg/day once daily for a 28-day cycle until disease progression, unacceptable toxicity, or enrollment in a long-term extension study, whichever occurs earlier. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Mantle Cell Lymphoma | |||
Intervention ICMJE | Drug: PCI-32765
560 mg daily
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Study Arms ICMJE | Experimental: Participants received PCI-32765 560 mg daily
Participants were enrolled and received 560 mg/day dose, stratified into 2 groups based on prior bortezomib exposure.
Intervention: Drug: PCI-32765
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
115 | |||
Original Estimated Enrollment ICMJE |
50 | |||
Actual Study Completion Date ICMJE | January 2014 | |||
Actual Primary Completion Date | January 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Major exclusion criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Germany, Poland, United Kingdom, United States | |||
Removed Location Countries | Austria | |||
Administrative Information | ||||
NCT Number ICMJE | NCT01236391 | |||
Other Study ID Numbers ICMJE | PCYC-1104-CA PCI-32765 ( Other Identifier: Pharmacyclics ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Pharmacyclics LLC. | |||
Original Responsible Party | Eric Hedrick, MD, Phramacyclics | |||
Current Study Sponsor ICMJE | Pharmacyclics LLC. | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Janssen Pharmaceuticals | |||
Investigators ICMJE |
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PRS Account | Pharmacyclics LLC. | |||
Verification Date | August 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |