Phase IIa Vorinostat (MK0683, Suberoylanilide Hydroxamic Acid (SAHA)) Study in Lower Risk Myelodysplastic Syndromes (0683-064)

NCT ID: NCT00486720

Last Updated: 2015-07-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2009-07-31

Brief Summary

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

Conditions

Myelodysplastic Syndromes; Blood Disease; Bone Marrow Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

vorinostat 400 mg

Group Type: EXPERIMENTAL

vorinostat

Intervention Type: DRUG

vorinostat 400 mg by mouth (P.O.) capsules once daily (q.d.). Treatment in 21 day cycles for up to 8 cycles.

2

vorinostat 200 mg

Group Type: EXPERIMENTAL

vorinostat

Intervention Type: DRUG

vorinostat 200 mg by mouth (P.O.) capsules three times daily (t.i.d.). Treatment in 21 day cycles for up to 8 cycles.

Interventions

vorinostat

vorinostat 400 mg by mouth (P.O.) capsules once daily (q.d.). Treatment in 21 day cycles for up to 8 cycles.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

suberoylanilide hydroxamic acid (SAHA); ZOLINZA®; suberoylanilide hydroxamic acid (SAHA); ZOLINZA®

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

MK0683-064

Identifier Type: -

Identifier Source: secondary_id

2007_536

Identifier Type: -

Identifier Source: secondary_id

0683-064

Identifier Type: -

Identifier Source: org_study_id