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A Study of Oral Suberoylanilide Hydroxamic Acid (Vorinostat) in Patients With Solid Tumors (0683-048)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00373490
First received: September 7, 2006
Last updated: June 19, 2014
Last verified: June 2014
Results First Received: October 20, 2008  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Tumors
Intervention: Drug: Vorinostat

  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
Phase I. First participant started on study therapy on 18-Jul-2006. Study was multicenter (total of 3 sites).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Study of 2 doses of vorinostat (MK-0683) in participants with solid tumors who failed standard therapy. >= 3 participants were enrolled at each dose. In the case of a dose level toxicity, a maximum of 6 participants were enrolled per level. If no safety problems, a total of 10 participants were evaluated for pharmacokinetics.

Reporting Groups
  Description
Vorinostat 600 mg 600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
Vorinostat 400 mg 400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days

Participant Flow:   Overall Study
    Vorinostat 600 mg     Vorinostat 400 mg  
STARTED     10     6  
COMPLETED     1     0  
NOT COMPLETED     9     6  
Adverse Event                 0                 1  
Lack of Efficacy                 9                 4  
Withdrawal by Subject                 0                 1  



  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
Vorinostat 600 mg 600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
Vorinostat 400 mg 400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
Total Total of all reporting groups

Baseline Measures
    Vorinostat 600 mg     Vorinostat 400 mg     Total  
Number of Participants  
[units: participants]
  10     6     16  
Age  
[units: years]
Mean ± Standard Deviation
  60.2  ± 8.4     53.3  ± 12     57.6  ± 10.1  
Gender  
[units: participants]
     
Female     2     2     4  
Male     8     4     12  
Prior chemotherapy regimens  
[units: Number of prior chemotherapy regimens]
Median ( Full Range )
  3.5  
  ( 2 to 6 )  
  4.5  
  ( 3 to 6 )  
  4  
  ( 2 to 6 )  



  Outcome Measures
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1.  Primary:   Number of Participants With a Dose Limiting Toxicity (DLT)   [ Time Frame: 21 Days (first cycle) ]

2.  Secondary:   Area Under the Curve (AUC(0-infinity)) at Day 1 (600 mg and 400 mg)   [ Time Frame: Day 1 (600 mg and 400 mg) ]

3.  Secondary:   Area Under the Curve (AUC(0-infinity)) at Day 3 (600 mg)   [ Time Frame: Day 3 (600 mg) ]

4.  Secondary:   Area Under the Curve (AUC(0-infinity) at Day 21 (400 mg)   [ Time Frame: Day 21 (400 mg) ]

5.  Secondary:   Maximum Concentration (Cmax) at Day 1 (600 mg and 400 mg)   [ Time Frame: Day 1 (600 mg and 400 mg) ]

6.  Secondary:   Maximum Concentration (Cmax) at Day 3 (600 mg)   [ Time Frame: Day 3 (600 mg) ]

7.  Secondary:   Maximum Concentration (Cmax) at Day 21 (400 mg)   [ Time Frame: Day 21 (400 mg) ]


  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 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: Senior Vice President, Global Clinical Development
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: NCT00373490     History of Changes
Other Study ID Numbers: 0683-048, MK0683-048, 2006_030
Study First Received: September 7, 2006
Results First Received: October 20, 2008
Last Updated: June 19, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency