Back to results

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

Primary Purpose

Myelodysplastic Syndromes, Blood Disease, Bone Marrow Disease

Status

Terminated

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

vorinostat

About this trial

This is an interventional treatment trial for Myelodysplastic Syndromes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

vorinostat 400 mg

vorinostat 200 mg

Outcomes

Primary Outcome Measures

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.

Safety and Tolerability as Assessed by the Number of Participants With Adverse Events.

Secondary Outcome Measures

Full Information

NCT ID

NCT00486720

First Posted

June 14, 2007

Last Updated

June 8, 2015

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00486720

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Terminated

Study Start Date

June 2007 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myelodysplastic Syndromes, Blood Disease, Bone Marrow Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

vorinostat 400 mg

Arm Title

Arm Type

Experimental

Arm Description

vorinostat 200 mg

Intervention Type

Drug

Intervention Name(s)

vorinostat

Other Intervention Name(s)

suberoylanilide hydroxamic acid (SAHA), ZOLINZA®

Intervention Description

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

Intervention Name(s)

vorinostat

Other Intervention Name(s)

suberoylanilide hydroxamic acid (SAHA), ZOLINZA®

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Responders and Number of Non-responders Defined by International Working Group Response Criteria

Description

Time Frame

2 Years

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs