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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00127127
First Posted: August 5, 2005
Last Update Posted: February 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
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
Tumors Drug: vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: Duration of Trial ]

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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00127127


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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00127127     History of Changes
Other Study ID Numbers: 0683-029
2005_040
First Submitted: August 3, 2005
First Posted: August 5, 2005
Last Update Posted: February 3, 2015
Last Verified: February 2015

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

Additional relevant MeSH terms:
Vorinostat
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action