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

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT00479232
Phase
PHASE1
Status
Completed

Conditions

  • Leukemia, Myelocytic, Acute Myelodysplastic Syndromes
  • Myelodysplastic Syndromes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This study is to evaluate the safety and tolerability of vorinostat in combination with decitabine as well as the in vivo molecular and biological effects of vorinostat in patients with refractory or relapsed Acute Myelogenous Leukemia (AML) and intermediate or high risk as defined by International Prognostic Scoring System (IPSS) Myelodysplastic Syndrome (MDS). Participants with Acute Myelogenous Leukemia or Myelodysplastic Syndrome are eligible.

Key Dates

Start date
Jun 30, 2007
Status verified
Sep 2015
Primary completion
Apr 30, 2010
Completion
Mar 31, 2012

Study Design

Enrollment
71 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Vorinostat (sequential)
    Vorinostat 400 mg capsules once daily given 7, 10 or 14 days in 28 day cycles. Up to 24 months of treatment. Decitabine IV 20 mg/m\^2 daily for 5 days in each 28 day cycle. Up to 24 months of treatment.
  • Experimental: Cohort 2: Vorinostat (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. Decitabine IV 20 mg/m\^2 daily for 5 days in each 28 day cycle. Up to 24 months of treatment.

Primary Outcome Measure

Number of Participants Experiencing Dose Limiting Toxicity (DLT) Events [ Time Frame: Day 1 to 28 of Cycle 1 ]

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