Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Solid Tumors (0683-029)(COMPLETED)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: August 3, 2005
Last updated: February 2, 2015
Last verified: February 2015

The primary purpose of this trial is to determine the maximum tolerated dose (MTD), or the maximum acceptable dose (MAD) and evaluate the dose limiting toxicity (DLT) of oral suberoylanilide hydroxamic acid in patients with solid tumors.

Condition Intervention Phase
Drug: vorinostat, Suberoylanilide Hydroxamic Acid (SAHA)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Clinical Study of MK0683 in Patients With Solid Tumors.

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Safety [ Time Frame: Duration of Trial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: Duration of Trial ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: June 2005
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
1. level 1: 100 mg BID 14-day, level 2: 200 mg BID 14-day, level 3: 400 mg QD 14 day, level 5: 500 mg QD 14-day
Drug: vorinostat, Suberoylanilide Hydroxamic Acid (SAHA)
vorinostat; level 1: 100 mg BID 14-day, level 2: 200 mg BID 14-day, level 3: 400 mg QD 14 day, level 5: 500 mg QD 14-day
Other Names:
  • MK0683
  • vorinostat
  • SAHA


Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with histologically or cytologically diagnosed solid tumor; no standard therapy available or patient has failed to respond to standard therapy

Exclusion Criteria:

  • Patients with history of immunotherapy, radiotherapy, surgery, or chemotherapy during the previous 4 weeks; previous treatment is 5 or more chemotherapeutic regimens.
  • Any uncontrolled concomitant illness
  • Are pregnant or breast-feeding
  • Serious drug or food allergy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00127127

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00127127     History of Changes
Other Study ID Numbers: 0683-029, 2005_040
Study First Received: August 3, 2005
Last Updated: February 2, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Merck Sharp & Dohme Corp.:
Solid tumors

Additional relevant MeSH terms:
Antineoplastic Agents
Enzyme Inhibitors
Histone Deacetylase Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on February 27, 2015