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

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ClinicalTrials.gov Identifier: NCT00127127
Recruitment Status : Completed
First Posted : August 5, 2005
Last Update Posted : February 3, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Tumors Drug: vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
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.
Study Start Date : June 2005
Primary Completion Date : August 2009
Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Vorinostat
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Safety [ Time Frame: Duration of Trial ]

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

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: August 5, 2005    Key Record Dates
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