Clinical Trial of MK0683 in Combination With FDA Approved Cancer Drugs in Patients With Advanced NSCLC (MK0683-058)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00423449
First received: January 17, 2007
Last updated: July 6, 2011
Last verified: July 2011
Results First Received: July 6, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Non-Small Cell Lung Cancer
Interventions: Drug: vorinostat
Drug: Gemcitabine
Drug: Platinum-based agent

  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
Vorinostat 300 7/21+ Gemcitabine 1000 + Cisplatin Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1000 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
Vorinostat 300 7/21+ Gemcitabine 1250 + Cisplatin Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
Vorinostat 400 7/21+ Gemcitabine 1250 + Cisplatin Vorinostat 400 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
Vorinostat 400 10/21+ Gemcitabine 1250 + Cisplatin Vorinostat 400 mg given the first 10 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
Vorinostat 400 14/21+ Gemcitabine 1250 + Cisplatin Vorinostat 400 mg given the first 14 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.

Participant Flow:   Overall Study
    Vorinostat 300 7/21+ Gemcitabine 1000 + Cisplatin     Vorinostat 300 7/21+ Gemcitabine 1250 + Cisplatin     Vorinostat 400 7/21+ Gemcitabine 1250 + Cisplatin     Vorinostat 400 10/21+ Gemcitabine 1250 + Cisplatin     Vorinostat 400 14/21+ Gemcitabine 1250 + Cisplatin  
STARTED     4     6     17     27     7  
COMPLETED     1     2     2     5     0  
NOT COMPLETED     3     4     15     22     7  
Clinical Adverse Event                 1                 0                 1                 8                 2  
Death                 1                 0                 2                 1                 1  
Progressive Disease                 1                 3                 8                 11                 4  
Laboratory Adverse Event                 0                 1                 2                 0                 0  
Not Specified                 0                 0                 0                 1                 0  
Protocol Violation                 0                 0                 2                 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
All Participants Vorinostat + Gemcitabine + Cisplatin

Baseline Measures
    All Participants  
Number of Participants  
[units: participants]
  61  
Age  
[units: years]
Mean ± Standard Deviation
  56.7  ± 9.2  
Gender  
[units: participants]
 
Female     17  
Male     44  



  Outcome Measures
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1.  Primary:   Number of Participants With Dose-limiting Toxicities (DLT) Due to Vorinostat Administered in Combination With Standard Dose of Gemcitabine Plus Either Cisplatin or Carboplatin   [ Time Frame: every 21 days (every cycle), up to 126 days (6 cycles) ]

2.  Primary:   Maximum Tolerated Dose of Vorinostat Administered in Combination With Standard Doses of Gemcitabine Plus Either Cisplatin or Carboplatin in Patients With Advanced Stage Non-Small Cell Lung Cancer Who Have Not Received Chemotherapy for Advanced Disease   [ Time Frame: every 21 days (every cycle), up to 126 days (6 cycles) ]

3.  Secondary:   Number of Participants With Clinical Adverse Experiences (Safety and Tolerability)   [ Time Frame: every 21 days (every cycle), up to 126 days (6 cycles) ]

4.  Secondary:   Number of Participants With Laboratory Adverse Experiences (Safety and Tolerability)   [ Time Frame: every 21 days (every cycle), up to 126 days (6 cycles) ]


  Serious Adverse Events


  Other Adverse Events


  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.


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.  


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


No publications provided


Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00423449     History of Changes
Other Study ID Numbers: MK-0683-058, 2006_528
Study First Received: January 17, 2007
Results First Received: July 6, 2011
Last Updated: July 6, 2011
Health Authority: France: Ministry of Health