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A Study of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Solid Tumors

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00373490
First received: September 7, 2006
Last updated: May 20, 2009
Last verified: May 2009
History of Changes
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: Suberoylanilide Hydroxamic Acid (SAHA)

  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 suberoylanilide hydroxamic acid (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
Suberoylanilide Hydroxamic Acid (600 mg) 600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest
Suberoylanilide Hydroxamic Acid (400 mg) 400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days

Participant Flow:   Overall Study
    Suberoylanilide Hydroxamic Acid (600 mg)     Suberoylanilide Hydroxamic Acid (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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Reporting Groups
  Description
Suberoylanilide Hydroxamic Acid (600 mg) 600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest
Suberoylanilide Hydroxamic Acid (400 mg) 400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
Total Total of all reporting groups

Baseline Measures
    Suberoylanilide Hydroxamic Acid (600 mg)     Suberoylanilide Hydroxamic Acid (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) ]
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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) ]
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3.  Secondary:   Area Under the Curve (AUC(0-infinity)) at Day 3 (600 mg)   [ Time Frame: Day 3 (600 mg) ]
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4.  Secondary:   Area Under the Curve (AUC(0-infinity) at Day 21 (400 mg)   [ Time Frame: Day 21 (400 mg) ]
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5.  Secondary:   Maximum Concentration (Cmax) at Day 1 (600 mg and 400 mg)   [ Time Frame: Day 1 (600 mg and 400 mg) ]
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6.  Secondary:   Maximum Concentration (Cmax) at Day 3 (600 mg)   [ Time Frame: Day 3 (600 mg) ]
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7.  Secondary:   Maximum Concentration (Cmax) at Day 21 (400 mg)   [ Time Frame: Day 21 (400 mg) ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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: Senior Vice President, Clinical and Quantitative Sciences
Organization: Merck & Co., Inc.
phone: 1-800-672-6372


No publications provided


Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00373490     History of Changes
Other Study ID Numbers: 2006_030, MK0683-048
Study First Received: September 7, 2006
Results First Received: October 20, 2008
Last Updated: May 20, 2009
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency