An Investigational Study of a Histone Deacetylase (HDAC) Inhibitor Plus Targretin in Cutaneous T-Cell Lymphoma Patients (0683-016)(TERMINATED)

This study has been terminated.
(The study was stopped due to low enrollment.)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00127101
First received: August 2, 2005
Last updated: July 15, 2014
Last verified: July 2014
Results First Received: July 6, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lymphoma
Interventions: Drug: vorinostat
Drug: Comparator: bexarotene

  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
No text entered.

Reporting Groups
  Description
Cohort 1 Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
Cohort 2 Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
Cohort 2a Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter[2] daily x 7 days per week
Cohort 2b Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter[2] daily x 7 days per week
Cohort 6 Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week
Cohort 7 Vorinostat 400 milligrams daily for 7 days per week + Bexarotene daily for 7 days per week [150 milligrams (Cycle 1) 225 milligrams (Cycle 2-6)]

Participant Flow for 2 periods

Period 1:   Base Protocol
    Cohort 1     Cohort 2     Cohort 2a     Cohort 2b     Cohort 6     Cohort 7  
STARTED     3     5     3     3     5     4  
COMPLETED     1     1     1     3     3     3  
NOT COMPLETED     2     4     2     0     2     1  
Adverse Event                 0                 2                 1                 0                 0                 0  
Lack of Efficacy                 1                 0                 0                 0                 2                 0  
Withdrawal by Subject                 1                 2                 1                 0                 0                 1  

Period 2:   Continuation Phase
    Cohort 1     Cohort 2     Cohort 2a     Cohort 2b     Cohort 6     Cohort 7  
STARTED     0     0     1     0 [1]   3     3  
COMPLETED     0     0     0     0     0     0  
NOT COMPLETED     0     0     1     0     3     3  
Adverse Event                 0                 0                 0                 0                 1                 1  
Lack of Efficacy                 0                 0                 0                 0                 0                 1  
Withdrawal by Subject                 0                 0                 1                 0                 2                 1  
[1] No patients from the 2b Cohort entered into the extension phase



  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 Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
Cohort 2 Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
Cohort 2a Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter[2] daily x 7 days per week
Cohort 2b Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter[2] daily x 7 days per week
Cohort 6 Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week
Cohort 7 Vorinostat 400 milligrams daily for 7 days per week + Bexarotene daily for 7 days per week [150 milligrams (Cycle 1) 225 milligrams (Cycle 2-6)]
Total Total of all reporting groups

Baseline Measures
    Cohort 1     Cohort 2     Cohort 2a     Cohort 2b     Cohort 6     Cohort 7     Total  
Number of Participants  
[units: participants]
  3     5     3     3     5     4     23  
Age, Customized  
[units: participants]
             
26-35 years of age     0     0     1     0     1     0     2  
36-45 years of age     1     1     0     0     0     0     2  
46-55 years of age     0     0     1     1     1     1     4  
56-65 years of age     1     1     1     2     3     1     9  
66-75 years of age     1     1     0     0     0     2     4  
Over 75 years of age     0     2     0     0     0     0     2  
Gender  
[units: participants]
             
Female     2     1     0     2     2     2     9  
Male     1     4     3     1     3     2     14  
Race/Ethnicity  
[units: participants]
             
Turkish     0     0     0     1     0     0     1  
White     3     5     3     2     5     4     22  



  Outcome Measures
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1.  Primary:   Maximum Tolerated Dose (MTD) as Determined by the Number of Participants With Dose Limiting Toxicities   [ Time Frame: Day 1 to day 28 ]

2.  Secondary:   Number of Participants Who Responded to Treatment   [ Time Frame: Every 28 days for up to 6 Months of Treatment ]


  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
Study was discontinued due to low enrollment


  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: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: clinicaltrialsdisclosure@merck.com


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00127101     History of Changes
Other Study ID Numbers: 0683-016, MK0683-016, 2005_019
Study First Received: August 2, 2005
Results First Received: July 6, 2009
Last Updated: July 15, 2014
Health Authority: United States: Food and Drug Administration