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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase I Clinical Trial of Vorinostat in Combination With Decitabine in Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome

Brief Summary: 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.

Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.

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

Participants who received at least one dose of vorinostat in combination with decitabine intravenous (IV) at a dose of 20 mg/m^2 daily for 5 days along with oral vorinostat 400 mg once daily for 7 to 14 days in a 28-day cycle concurrently or sequentially, were evaluated to determine the maximum tolerable dose (MTD) determined by the number of participants experiencing dose limiting toxicity (DLT) events defined as any Grade 3 or 4 non-hematological toxicity (reported adverse event) and/or myelosuppression lasting >42 days.


Original Primary Outcome: To evaluate the safety and tolerability of this treatment combination.

Current Secondary Outcome:

Original Secondary Outcome: To determine the efficacy of this combination

Information By: Merck Sharp & Dohme Corp.

Dates:
Date Received: May 24, 2007
Date Started: June 2007
Date Completion:
Last Updated: September 4, 2015
Last Verified: September 2015