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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pharmacyclics
ClinicalTrials.gov Identifier:
NCT00724984
First received: July 28, 2008
Last updated: February 27, 2014
Last verified: February 2014
Results First Received: February 27, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Lymphoma
Hodgkin Disease
Lymphoma, Non-Hodgkin
Intervention: Drug: PCI-24781

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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
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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.
No text entered.

Reporting Groups
  Description
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  
Number of Participants  
[units: participants]
  5     8     3     9     16     14     55  
Age  
[units: years]
Median ( Full Range )
  68  
  ( 40 to 75 )  
  67  
  ( 47 to 76 )  
  62  
  ( 32 to 79 )  
  66  
  ( 44 to 76 )  
  62  
  ( 36 to 81 )  
  67  
  ( 59 to 77 )  
  66  
  ( 32 to 81 )  
Gender  
[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
  Show All 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
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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. Thorsten Graef
Organization: Pharmacyclics
phone: 855-427-8846
e-mail: pharmacyclics@medcomsol.com


Publications of Results:

Responsible Party: Pharmacyclics
ClinicalTrials.gov Identifier: NCT00724984     History of Changes
Other Study ID Numbers: PCYC-0403
Study First Received: July 28, 2008
Results First Received: February 27, 2014
Last Updated: February 27, 2014
Health Authority: United States: Food and Drug Administration