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

Myelodysplastic Syndromes Clinical Trial

Official title:

A Randomized Phase IIa Study of Vorinostat in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00486720
• Other study ID #: 0683-064
• Secondary ID: MK0683-0642007_5
• Status: Terminated
• Phase: Phase 2
• First received: June 14, 2007
• Last updated: June 8, 2015
• Start date: June 2007
• Est. completion date: July 2009

Study information

• Verified date: June 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Disease
• Bone Marrow Disease
• Bone Marrow Diseases
• Hematologic Diseases
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Responders and Number of Non-responders Defined by International Working Group Response Criteria	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.	2 Years	No
Primary	Safety and Tolerability as Assessed by the Number of Participants With Adverse Events.		Every 21 days while on therapy and at 30 days after the last dose of study therapy	Yes