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

NCT00486720 | Terminated Phase 2 Results

• 3 other identifiers: 0683-064MK0683-0642007_536
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

1

EXPERIMENTAL

vorinostat 400 mg

Drug: vorinostat

2

EXPERIMENTAL

vorinostat 200 mg

Drug: vorinostat

Interventions

vorinostat DRUG

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

Also known as: suberoylanilide hydroxamic acid (SAHA), ZOLINZA®

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Myelodysplastic Syndromes; Hematologic Diseases; Bone Marrow Diseases

Interventions

Vorinostat

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Hydroxamic Acids; Hydroxylamines; Hydroxy Acids; Carboxylic Acids

Limitations and Caveats

This trial was terminated because the pre-specified futility criterion was met.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2007
• First Posted: June 15, 2007
• Study Start: June 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: July 3, 2015
• Results First Posted: June 22, 2010

Record last verified: 2015-06