Phase IIa Vorinostat (MK0683, 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 MDS.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
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

Drug Information available for: Suberoylanilide hydroxamic acid

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Overall Response Rate defined by International Working Group Response Criteria [ Time Frame: Every 21 days while on therapy, every 42 days in extension phase for those patients who discontinue for reasons other than disease progression and at 30 days after the last dose of study therapy ] [ Designated as safety issue: No ]
Safety and tolerability as assessed by incidence of adverse events [ Time Frame: Throughout the study ] [ 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
1: Experimental vorinostat 400 mg	Drug: Comparator: vorinostat Arm 1: vorinostat 400 mg P.O. q.d. capsules once daily Arm 2: vorinostat 200 mg P.O. t.i.d. capsules three times daily. Treatment in 21 day cycles for up to 8 cycles.
2: Experimental vorinostat 200 mg	Drug: Comparator: vorinostat Arm 1: vorinostat 400 mg P.O. q.d. capsules once daily Arm 2: vorinostat 200 mg P.O. t.i.d. capsules three times daily. Treatment in 21 day cycles for up to 8 cycles.

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 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 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:	Merck Sharp & Dohme Corp ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_536, MK0683-064
Study First Received:	June 14, 2007
Last Updated:	January 20, 2010
ClinicalTrials.gov Identifier:	NCT00486720 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anticarcinogenic Agents
Precancerous Conditions
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Preleukemia
Pathologic Processes
Sensory System Agents
Syndrome
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics

Disease
Hematologic Diseases
Vorinostat
Myelodysplastic Syndromes
Enzyme Inhibitors
Protective Agents
Pharmacologic Actions
Neoplasms
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Bone Marrow Diseases
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010