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Phase I Trial of Vorinostat (MK-0683, SAHA) in Combination With Decitabine in Patients With AML or MDS (MK-0683-055 EXT1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00479232
First received: May 24, 2007
Last updated: February 5, 2013
Last verified: February 2013
History of Changes
Results First Received: April 28, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Leukemia, Myelocytic, Acute Myelodysplastic Syndromes
Myelodysplastic Syndromes
Interventions: Drug: vorinostat
Drug: decitabine

  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
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Reporting Groups
  Description
Concurrent, Vorinostat 400mg qd x 7d/4wk + Decitabine (concurrent) vorinostat 400 mg capsules given once daily (qd) on Days 1 to 7 in a 28 day cycle, along with decitabine intravenous (IV) 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
Concurrent, Vorinostat 400mg qd x 7d/2wk + Decitabine (concurrent) vorinostat 400 mg capsules given qd on Days 1 to 7 and Days 15 to 21 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
Concurrent, Vorinostat 400mg qd x 14d/4wk + Decitabine (MTD) (concurrent) vorinostat 400 mg capsules given qd on Days 1 to 14 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
Sequential, Vorinostat 400mg qd x 7d/4wk + Decitabine (sequential) vorinostat 400 mg capsules given qd on Days 6 to 12 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
Sequential, Vorinostat 400mg qd x 10d/4wk + Decitabine (sequential) vorinostat 400 mg capsules given qd on Days 6 to 15 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
Sequential, Vorinostat 400mg qd x 14d/4wk + Decitabine (MTD) (sequential) vorinostat 400 mg capsules given qd on Days 6 to 19 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.

Participant Flow:   Overall Study
    Concurrent, Vorinostat 400mg qd x 7d/4wk + Decitabine     Concurrent, Vorinostat 400mg qd x 7d/2wk + Decitabine     Concurrent, Vorinostat 400mg qd x 14d/4wk + Decitabine (MTD)     Sequential, Vorinostat 400mg qd x 7d/4wk + Decitabine     Sequential, Vorinostat 400mg qd x 10d/4wk + Decitabine     Sequential, Vorinostat 400mg qd x 14d/4wk + Decitabine (MTD)  
STARTED     3     3     28     3     4     30  
COMPLETED     0     0     0     0     0     0  
NOT COMPLETED     3     3     28     3     4     30  
Adverse Event                 0                 0                 5                 0                 0                 10  
Deviation from Protocol                 0                 0                 1                 0                 0                 0  
Lack of Efficacy                 0                 0                 2                 0                 0                 4  
Physician Decision                 0                 0                 2                 0                 0                 1  
Progressive Disease                 3                 1                 12                 3                 3                 12  
Withdrew Consent                 0                 2                 6                 0                 1                 3  



  Baseline Characteristics
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Reporting Groups
  Description
Vorinostat + Decitabine, Concurrent (concurrent) Vorinostat 400 mg capsules once daily given 7 days, 14 days with 8 day break after first 7 days or 14 days without break, out of 28 day cycles along with decitabine IV 20 mg/m^2 daily for 5 days in each 28 day cycle. Up to 24 months of treatment.
Vorinostat + Decitabine, Sequential (sequential) Vorinostat 400 mg capsules once daily given 7, 10 or 14 days in 28 day cycles along with decitabine IV 20 mg/m^2 daily for 5 days in each 28 day cycle. Up to 24 months of treatment.
Total Total of all reporting groups

Baseline Measures
    Vorinostat + Decitabine, Concurrent     Vorinostat + Decitabine, Sequential     Total  
Number of Participants  
[units: participants]
 		  34     37     71  
Age  
[units: years]
Mean ± Standard Deviation 		  63.9  ± 13.0     66.6  ± 13.8     65.3  ± 13.4  
Gender  
[units: participants]
 		     
Female     11     18     29  
Male     23     19     42  



  Outcome Measures
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1.  Primary:   Number of Participants Experiencing Dose Limiting Toxicity (DLT) Events   [ Time Frame: Day 1 to 28 of Cycle 1 ]
  Show Outcome Measure 1

2.  Other Pre-specified:   Objective Response Rate in Participants Treated With Vorinostat + Decitabine With Refractory or Relapse Acute Myelogenous Leukemia (AML)   [ Time Frame: Approximately 6 months ]
  Show Outcome Measure 2

3.  Other Pre-specified:   Objective Response Rate in Participants Treated With Vorinostat + Decitabine With Intermediate-high Risk Myelodysplastic Syndrome (MDS) or Untreated Acute Myelogenous Leukemia (AML)   [ Time Frame: Approximately 6 months ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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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.


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
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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: Merck
ClinicalTrials.gov Identifier: NCT00479232     History of Changes
Other Study ID Numbers: MK-0683-055, 2007_500
Study First Received: May 24, 2007
Results First Received: April 28, 2011
Last Updated: February 5, 2013
Health Authority: United States: Food and Drug Administration