Study of the Safety and Tolerability of PCI-24781 in Patients With Lymphoma (PCYC-0403)

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: NCT00724984
Recruitment Status : Completed
First Posted : July 30, 2008
Results First Posted : April 7, 2014
Last Update Posted : April 7, 2014
Information provided by (Responsible Party):
Pharmacyclics LLC.

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Lymphoma
Hodgkin Disease
Lymphoma, Non-Hodgkin
Intervention: Drug: PCI-24781

  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
No text entered.

Reporting Groups
Cohort 1(30mg/m2,5days/wk)/Phase 1 No text entered.
Cohort 2(45mg/m2,5days/wk)/Phase 1 No text entered.
Cohort 3(45mg/m2,7days/wk)/Phase 1 No text entered.
Cohort 4(60mg/m2,7days/wk)/Phase 1 No text entered.
Follicular/Phase II No text entered.
Mantle Cell Lymphoma/Phase II No text entered.

Participant Flow:   Overall Study
    Cohort 1(30mg/m2,5days/wk)/Phase 1   Cohort 2(45mg/m2,5days/wk)/Phase 1   Cohort 3(45mg/m2,7days/wk)/Phase 1   Cohort 4(60mg/m2,7days/wk)/Phase 1   Follicular/Phase II   Mantle Cell Lymphoma/Phase II
STARTED   5   8   3   9   16   14 
COMPLETED   4   7   3   7   12   9 
NOT COMPLETED   1   1   0   2   4   5 

  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.
No text entered.

Reporting Groups
Cohort 1(30 mg/m2, 5days/wk)/Phase 1 No text entered.
Cohort 2(45 mg/m2, 5days/wk)/Phase 1 No text entered.
Cohort 3(45 mg/m2, 7days/wk)/Phase 1 No text entered.
Cohort 4(60 mg/m2,7days/wk)/Phase 1 No text entered.
Follicular/Phase II No text entered.
Mantle Cell Lymphoma/Phase II No text entered.
Total Total of all reporting groups

Baseline Measures
   Cohort 1(30 mg/m2, 5days/wk)/Phase 1   Cohort 2(45 mg/m2, 5days/wk)/Phase 1   Cohort 3(45 mg/m2, 7days/wk)/Phase 1   Cohort 4(60 mg/m2,7days/wk)/Phase 1   Follicular/Phase II   Mantle Cell Lymphoma/Phase II   Total 
Overall Participants Analyzed 
[Units: Participants]
 5   8   3   9   16   14   55 
[Units: Years]
Median (Full Range)
 (40 to 75) 
 (47 to 76) 
 (32 to 79) 
 (44 to 76) 
 (36 to 81) 
 (59 to 77) 
 (32 to 81) 
[Units: Participants]
Female   1   5   1   3   8   12   30 
Male   4   3   2   6   8   2   25 
Region of Enrollment 
[Units: Participants]
United States   5   8   3   9   16   14   55 

  Outcome Measures

1.  Primary:   Phase I (Dose Escalation Phase): MTD and DLTs of PCI-24781 Administered Twice Daily (BID) Measure: Disease Response   [ Time Frame: From the Date of PCI-24781 first administration to Cycle 2 Day 1 ]

2.  Primary:   Phase II: Overall Response Rate (CR+PR)   [ Time Frame: From first response assessment (day 22 to 28 of Cycle 2) to last response assessment on day 22-28 in even-numbered cycles ]

  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
No text entered.

  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. Thorsten Graef
Organization: Pharmacyclics
phone: 855-427-8846

Publications of Results:

Responsible Party: Pharmacyclics LLC. Identifier: NCT00724984     History of Changes
Other Study ID Numbers: PCYC-0403
First Submitted: July 28, 2008
First Posted: July 30, 2008
Results First Submitted: February 27, 2014
Results First Posted: April 7, 2014
Last Update Posted: April 7, 2014