Phase IIa Vorinostat (MK0683, Suberoylanilide Hydroxamic Acid (SAHA)) Study in Lower Risk Myelodysplastic Syndromes - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00486720

Purpose

This study is to evaluate the efficacy, safety and tolerability of vorinostat in patients with lower risk Myelodysplastic Syndrome (MDS).

Condition	Intervention	Phase
Myelodysplastic Syndromes Blood Disease Bone Marrow Disease	Drug: vorinostat	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized Phase IIa Study of Vorinostat in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Bone Marrow Diseases Myelodysplastic Syndromes

Drug Information available for: Suberoylanilide hydroxamic acid

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Number of Responders and Number of Non-responders Defined by International Working Group Response Criteria [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
Number of responders is defined as the number of patients in the analysis population who have complete response (CR), partial response (PR), or hematologic improvement (HI) per International Working Group Response Criteria during the course of the study. Confirmation of CR or PR will require a second assessment performed 4 weeks or more after the initial assessment. Confirmation of HI will require a second assessment performed 8 weeks or more after the initial assessment. Number of non-responders is defined as the number of patients who did not achieve CR, PR or HI in the study.
Safety and Tolerability as Assessed by the Number of Participants With Adverse Events. [ Time Frame: Every 21 days while on therapy and at 30 days after the last dose of study therapy ] [ Designated as safety issue: Yes ]

Enrollment:	22
Study Start Date:	June 2007
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 vorinostat 400 mg	Drug: vorinostat vorinostat 400 mg by mouth (P.O.) capsules once daily (q.d.). Treatment in 21 day cycles for up to 8 cycles. Other Names: suberoylanilide hydroxamic acid (SAHA) ZOLINZA®
Experimental: 2 vorinostat 200 mg	Drug: vorinostat vorinostat 200 mg by mouth (P.O.) capsules three times daily (t.i.d.). Treatment in 21 day cycles for up to 8 cycles. Other Names: suberoylanilide hydroxamic acid (SAHA) ZOLINZA®

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient is a male or female, at least 18 years of age with low or intermediate-1 risk Myelodysplastic Syndrome (MDS) defined by the International Prognostic Scoring System

Patient has previously untreated disease, or has received up to one prior treatment regimen for lower-risk Myelodysplastic Syndrome
Patient has a performance status of equal to or less than 2 on the Eastern Cooperative Oncology Group Performance Scale
Patient must have adequate organ function

Exclusion Criteria:

Patient has clinical evidence of Central Nervous System (CNS) leukemia
Patient is pregnant or breastfeeding, or expecting to conceive within the projected duration of the study
Patient had prior treatment with a histone deacetylase inhibitor

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00486720

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00486720 History of Changes
Other Study ID Numbers:	2007_536, MK0683-064
Study First Received:	June 14, 2007
Results First Received:	April 19, 2010
Last Updated:	May 24, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Bone Marrow Diseases
Hematologic Diseases
Myelodysplastic Syndromes
Preleukemia
Precancerous Conditions
Neoplasms
Vorinostat

Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012