Phase IIa Vorinostat (MK 0683, SAHA) Study in Lower Risk Myelodysplastic Syndromes
Information source: Merck
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Myelodysplastic Syndromes; Blood Disease; Bone Marrow Disease
Intervention: vorinostat (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Overall contact:
Toll Free Number, Phone: 1-888-577-8839
Summary
This study is to evaluate the efficacy, safety and tolerability of vorinostat in patients
with lower risk MDS.
Clinical Details
Official title: A Randomized Phase IIa Study of Vorinostat in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome
Study design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Primary outcome: Efficacy of vorinostat in this patient population.
Secondary outcome: Safety and tolerability of vorinostat in this patient population.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patient is a male or female with at least 18 years of age with low-intermediate I
myelodysplastic syndrome defined by the International Prognostic Scoring System
- Patient has previously untreated disease, or has received up to one prior treatment
regimen
Exclusion Criteria:
- Patient has clinical evidence of CNS leukemia
- Patient is pregnant or breastfeeding, or expecting to conceive within the projected
duration of the study
Locations and Contacts
Toll Free Number, Phone: 1-888-577-8839
Call for Information, Maywood, Illinois 60153, United States; Recruiting
Call for Information, Baltimore, Maryland 21201, United States; Recruiting
Call for Information, Boston, Massachusetts 02115, United States; Recruiting
Call for Information, Ann Arbor, Michigan 48109, United States; Recruiting
Call for Information, Hackensack, New Jersey 07601, United States; Recruiting
Call for Information, New York, New York 10029, United States; Recruiting
Call for Information, New York, New York 10011, United States; Recruiting
Call for Information, Winston-Salem, North Carolina 27157, United States; Recruiting
Call for Information, Houston, Texas 77030-4009, United States; Recruiting
Call for Information, Dallas, Texas 75390-8852, United States; Recruiting
Call for Information, Seattle, Washington 98104-1024, United States; Recruiting
Additional Information
(MedWatch - FDA maintained medical product safety Information) (PhRMA Clinical Study Results Database - web-based repository for clinical study results) (Merck: Patient & Caregiver U.S. Product Web Site)
Starting date: July 2007
Last updated: August 6, 2008
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