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Phase IIa Vorinostat (MK0683, Suberoylanilide Hydroxamic Acid (SAHA)) Study in Lower Risk Myelodysplastic Syndromes (0683-064)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00486720
First received: June 14, 2007
Last updated: November 14, 2013
Last verified: November 2013
Results First Received: April 19, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Myelodysplastic Syndromes
Blood Disease
Bone Marrow Disease
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
Date of first patient in was 26-Jun-2007. The date of last patient last visit for the study was 16-Jul-2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Vorinostat was studied in patients who were first stratified by their International Prognostic Scoring System

for myelodysplastic syndrome (low versus intermediate-1) and than randomized into one of two dose schedules.


Reporting Groups
  Description
Vorinostat Once Daily Dose Schedule Vorinostat 400 mg once daily for 14 consecutive days in a 21 day cycle.
Vorinostat Thrice Daily Dose Schedule Vorinostat 200 mg three times daily for 14 consecutive days in a 21 day cycle.

Participant Flow:   Overall Study
    Vorinostat Once Daily Dose Schedule     Vorinostat Thrice Daily Dose Schedule  
STARTED     10 [1]   12  
COMPLETED     0     0  
NOT COMPLETED     10     12  
Adverse Event                 1                 2  
Lack of Efficacy                 4                 6  
Physician Decision                 1                 2  
Protocol Violation                 1                 0  
Withdrawal by Subject                 3                 1  
Progressive Disease                 0                 1  
[1] 1 randomized patient was discontinued before receiving treatment due to a protocol violation



  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 Once Daily Dose Schedule Vorinostat 400 mg once daily for 14 consecutive days in a 21 day cycle.
Vorinostat Thrice Daily Dose Schedule Vorinostat 200 mg three times daily for 14 consecutive days in a 21 day cycle.
Total Total of all reporting groups

Baseline Measures
    Vorinostat Once Daily Dose Schedule     Vorinostat Thrice Daily Dose Schedule     Total  
Number of Participants  
[units: participants]
  9     12     21  
Age  
[units: years]
Mean ± Standard Deviation
  69.0  ± 18.5     64.0  ± 10.5     66.0  ± 14.1  
Gender  
[units: participants]
     
Female     1     5     6  
Male     8     7     15  
Race/Ethnicity, Customized  
[units: participants]
     
White     9     10     19  
Black     0     1     1  
Asian     0     1     1  
Eastern Cooperative Oncology Group (ECOG) Performance Scale Status [1]
[units: participants]
     
0 = Normal Activity     4     10     14  
1 = Symptoms, but ambulatory     4     1     5  
2 = In bed < 50% of the time     1     1     2  
International Prognostic Scoring System Risk (IPSS) [2]
[units: Participants]
     
Low     3     4     7  
Intermediate-1     6     8     14  
Prior Myelodysplastic Syndromes Therapy  
[units: Participants]
     
Yes     6     3     9  
No     3     9     12  
[1] ECOG Scale: 0 = Normal Activity, 1 = Symptoms, but ambulatory, 2 = In bed <50% of the time, 3 = In bed >50% of the time, 4 = 100% Bedridden, 5 = Dead
[2]

IPSS Risk: Low [Score = 0; Time to Acute myeloid leukemia (AML) (yrs) = 9.4; Median Survival (yrs) = 5.7]

IPSS Risk: INT-1 [Score = 0.5 - 1; Time to AML (yrs) = 3.3; Median Survival (yrs) = 3.5]

IPSS Risk: INT-2 [Score = 1.5 - 2; Time to AML (yrs) = 1.1; Median Survival (yrs) = 1.2]

IPSS Risk: High [Score = >2; Time to AML (yrs) = 0.2; Median Survival (yrs) = 0.4]




  Outcome Measures
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1.  Primary:   Number of Responders and Number of Non-responders Defined by International Working Group Response Criteria   [ Time Frame: 2 Years ]

2.  Primary:   Safety and Tolerability as Assessed by the Number of Participants With Adverse Events.   [ Time Frame: Every 21 days while on therapy and at 30 days after the last dose of study therapy ]


  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
This trial was terminated because the pre-specified futility criterion was met.


  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: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00486720     History of Changes
Other Study ID Numbers: 0683-064, MK0683-064, 2007_536
Study First Received: June 14, 2007
Results First Received: April 19, 2010
Last Updated: November 14, 2013
Health Authority: United States: Food and Drug Administration