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

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 2

Conditions: Bone Marrow Disease; Blood Disease; Myelodysplastic Syndromes

Treatments: Drug: vorinostat

Study type: Interventional

Funder types: Industry

Identifiers

NCT00486720

2007_536

MK0683-064

0683-064

Details and patient eligibility

About

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

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

22 participants in 2 patient groups

1

Experimental group

Description:

vorinostat 400 mg

Treatment:

Drug: vorinostat

Drug: vorinostat

2

Experimental group

Description:

vorinostat 200 mg

Treatment:

Drug: vorinostat

Drug: vorinostat