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A Study of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Malignant Lymphoma (0683-030)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00127140
First received: August 3, 2005
Last updated: May 29, 2012
Last verified: May 2012
History of Changes
  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 malignant lymphoma.


Condition Intervention Phase
Lymphoma
 Drug: vorinostat
 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 Malignant Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma
Drug Information available for: Vorinostat
U.S. FDA Resources

Further study details as provided by Merck:

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: 10
Study Start Date: June 2005
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
level 1: 100 mg BID 14-day, level 2: 200 mg BID 14-day
 Drug: vorinostat
vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) vorinostat; level 1: 100 mg BID 14-day, level 2: 200 mg BID 14-day

  Eligibility

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

Inclusion Criteria:

  • Patients who relapsed after complete or partial response, or ineffective in previous chemotherapy

Exclusion Criteria:

  • Patients with history of chemotherapy, antibody therapy, radiotherapy, during the previous 4 weeks (6 months for radioisotope-labeled antibody)
  • Any uncontrolled concomitant illness
  • Are pregnant or breast-feeding
  • Serious drug or food allergy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00127140

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided by Merck

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Vice President, Late State Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00127140     History of Changes
Other Study ID Numbers: MK-0683-030, 2005_041
Study First Received: August 3, 2005
Last Updated: May 29, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Vorinostat
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013