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A Phase III Randomized, Double Blind, Placebo Controlled Multi-center Study of Panobinostat for Maintenance of Response in Patients With Hodgkin's Lymphoma (HL) (PATH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01034163
First received: December 15, 2009
Last updated: May 27, 2016
Last verified: May 2016
Results First Received: March 1, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Hodgkin's Lymphoma
Interventions: Drug: Panobinostat
Drug: Placebo

  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
Participants were randomized in a 2:1 ratio to the PAN and placebo groups, respectively.

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

Reporting Groups
  Description
Panobinostat (PAN) Participants received 45 mg orally 3 times a week (TIW), every other week (QOW).
Placebo Participants received matching placebo to PAN TIW, QOW.

Participant Flow:   Overall Study
    Panobinostat (PAN)     Placebo  
STARTED     27     14  
Untreated (Not in Safety Set)     1     2  
Safety Set     26     12  
In Open Label Phase After Unblinding     5     0  
COMPLETED     0     0  
NOT COMPLETED     27     14  
Treatment completed as per protocol                 8                 7  
Withdrawal by Subject                 8                 2  
Protocol deviation                 1                 0  
Disease progression                 3                 4  
Adverse Event                 6                 0  
Administrative problems                 0                 1  
Abnormal laboratory value                 1                 0  



  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
Panobinostat (PAN) Participants received 45 mg orally 3 times a week (TIW), every other week (QOW).
Placebo Participants received matching placebo to PAN TIW, QOW.
Total Total of all reporting groups

Baseline Measures
    Panobinostat (PAN)     Placebo     Total  
Number of Participants  
[units: participants]
  27     14     41  
Age  
[units: Years]
Mean (Standard Deviation)
  34.0  (10.72)     30.6  (10.56)     32.9  (10.66)  
Gender  
[units: Participants]
     
Female     8     7     15  
Male     19     7     26  



  Outcome Measures

1.  Primary:   Number of Participants With Adverse Events   [ Time Frame: 23 months ]


  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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis
phone: 862-778-8300



Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01034163     History of Changes
Other Study ID Numbers: CLBH589E2301
2009-014846-26
Study First Received: December 15, 2009
Results First Received: March 1, 2016
Last Updated: May 27, 2016
Health Authority: United States: Food and Drug Administration