Trial record 1 of 1 for:    NCT01236391
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Safety and Efficacy of PCI-32765 in Participants With Relapsed/Refractory Mantle Cell Lymphoma (MCL) (PCYC-1104-CA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01236391
Recruitment Status : Completed
First Posted : November 8, 2010
Results First Posted : March 13, 2015
Last Update Posted : August 28, 2015
Janssen Pharmaceuticals
Information provided by (Responsible Party):
Pharmacyclics LLC.

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Mantle Cell Lymphoma
Intervention: Drug: PCI-32765

  Participant Flow

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
PCI-32765 Participants received 560 mg daily

Participant Flow:   Overall Study
STARTED   111 [1] 
COMPLETED   95 [2] 
[1] Participants who received study treatment
[2] Participants who were on treatment or discontinued treatment due to disease progression or death

  Baseline Characteristics

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
PCI-32765 PCI-32765: 560 mg daily

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   41 
>=65 years   70 
[Units: Years]
Mean (Standard Deviation)
 67.1  (8.6) 
[Units: Participants]
Female   26 
Male   85 
Region of Enrollment 
[Units: Participants]
United States   78 
Poland   10 
Germany   3 
United Kingdom   20 

  Outcome Measures

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

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

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

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Pharmacyclics LLC. Identifier: NCT01236391     History of Changes
Other Study ID Numbers: PCYC-1104-CA
PCI-32765 ( Other Identifier: Pharmacyclics )
First Submitted: October 18, 2010
First Posted: November 8, 2010
Results First Submitted: February 12, 2015
Results First Posted: March 13, 2015
Last Update Posted: August 28, 2015