Safety and Efficacy of PCI-32765 in Participants With Relapsed/Refractory Mantle Cell Lymphoma (MCL) (PCYC-1104-CA)

This study has been completed.
Sponsor:
Collaborator:
Janssen Pharmaceuticals
Information provided by (Responsible Party):
Pharmacyclics
ClinicalTrials.gov Identifier:
NCT01236391
First received: October 18, 2010
Last updated: March 4, 2015
Last verified: March 2015
Results First Received: February 12, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Mantle Cell Lymphoma
Intervention: Drug: PCI-32765

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One hundred fifteen subjects were enrolled and 111 subjects received at least 1 dose of ibrutinib and constitute the all treated population and the safety analysis set.

Reporting Groups
  Description
PCI-32765 Participants received 560 mg daily

Participant Flow:   Overall Study
    PCI-32765  
STARTED     111 [1]
COMPLETED     95 [2]
NOT COMPLETED     16  
[1] Participants who received study treatment
[2] Participants who were on treatment or discontinued treatment due to disease progression or death



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
One hundred fifteen subjects were enrolled and 111 subjects received at least 1 dose of ibrutinib and constitute the all treated population and the safety analysis set.

Reporting Groups
  Description
PCI-32765 PCI-32765: 560 mg daily

Baseline Measures
    PCI-32765  
Number of Participants  
[units: participants]
  111  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     41  
>=65 years     70  
Age  
[units: years]
Mean (Standard Deviation)
  67.1  (8.6)  
Gender  
[units: participants]
 
Female     26  
Male     85  
Region of Enrollment  
[units: participants]
 
United States     78  
Poland     10  
Germany     3  
United Kingdom     20  



  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   Number of Participants With Treatment Emergent Adverse Events (AEs)   [ Time Frame: From first dose of PCI-32765 to within 30 days of last dose for each participant or until study closure ]

3.  Secondary:   PCI-32765 and Its Metabolite (PCI-45227) AUC0-24h After Repeat Dosing of PCI-32765   [ Time Frame: Performed During the First Month of Receiving PCI-32765 ]

4.  Secondary:   Mean Change From Baseline to Cycle 5 in EORTC QLQ-C30 Global Health Status Score   [ Time Frame: From Baseline to Cycle 5 (Week 20) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Darrin Beaupre
Organization: Pharmacyclics, Inc.
phone: 855-427-8846
e-mail: medinfo@pcyc.com


No publications provided by Pharmacyclics

Publications automatically indexed to this study:

Responsible Party: Pharmacyclics
ClinicalTrials.gov Identifier: NCT01236391     History of Changes
Other Study ID Numbers: PCYC-1104-CA, PCI-32765
Study First Received: October 18, 2010
Results First Received: February 12, 2015
Last Updated: March 4, 2015
Health Authority: United States: Food and Drug Administration
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Ethics Commission
Germany: Ministry of Health
Poland: Ethics Committee
Poland: Ministry of Health