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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) | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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

NCT00479232•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patient is at least 18 years old with refractory/relapsed AML
•* If untreated AML, patient is older than 60 years old and not a candidate for standard chemotherapy
•Patient is at least 4 weeks from prior treatment and has recovered from all prior treatment side effects
•Patient has no known liver or kidney problems
•Patient knows of no reason they can not receive transfusions of blood clotting cells (platelets)
•Patient is able to swallow capsules
•Patients both male and female are willing to practice birth control during the study

Exclusion Criteria

•Patient has received prior treatment with valproic acid, decitabine or azacitidine
•Being is less than 18 years of age or if patient has untreated AML is below 60 years of age
•Patient is a women who is pregnant or breastfeeding. Patient has an active infection that requires antibiotics
•Patient has uncontrolled illness including but not limited to the following: heart problems (congestive heart failure, unstable angina pectoris, cardiac arrhythmia), inflammation of the pancreas; a mental or social condition that may interfere with patient following study procedures
•Patient has known human immunodeficiency virus (HIV) infection or HIV-related malignancy. Patient has a known history of hepatitis B or C infection
•Patient currently has another active cancer other than certain types of skin cancer
•Patient is heterosexual and able to have a child and is unwilling to practice birth control during the study

Key Dates

Start Date

June 1, 2007

Primary Completion Date

April 1, 2010

Completion Date

March 1, 2012

Last Updated

September 21, 2015

Enrollment

ACTUAL participants

Conditions

Leukemia, Myelocytic, Acute Myelodysplastic SyndromesMyelodysplastic Syndromes

Interventions

vorinostat

DRUG

decitabine

DRUG

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Acute Myeloid LeukemiaMyelodysplastic Syndromes+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 21, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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