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A Study of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Solid Tumors

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00373490
First received: September 7, 2006
Last updated: May 20, 2009
Last verified: May 2009
History of Changes
  Purpose

This is a clinical study to evaluate the safety and pharmacokinetics of an overseas determined maximum tolerated dose (MTD) of MK0683 (suberoylanilide hydroxamic acid) in a Japanese patient population with solid tumors.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: MK0683 Phase1 Clinical Study - Solid Tumor -

Resource links provided by NLM:

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

Further study details as provided by Merck:

Primary Outcome Measures:
  • Number of Participants With a Dose Limiting Toxicity (DLT) [ Time Frame: 21 Days (first cycle) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Area Under the Curve (AUC(0-Infinity)) at Day 1 (600 mg and 400 mg) [ Time Frame: Day 1 (600 mg and 400 mg) ] [ Designated as safety issue: No ]
  • Area Under the Curve (AUC(0-Infinity)) at Day 3 (600 mg) [ Time Frame: Day 3 (600 mg) ] [ Designated as safety issue: No ]
  • Area Under the Curve (AUC(0-Infinity) at Day 21 (400 mg) [ Time Frame: Day 21 (400 mg) ] [ Designated as safety issue: No ]
  • Maximum Concentration (Cmax) at Day 1 (600 mg and 400 mg) [ Time Frame: Day 1 (600 mg and 400 mg) ] [ Designated as safety issue: No ]
  • Maximum Concentration (Cmax) at Day 3 (600 mg) [ Time Frame: Day 3 (600 mg) ] [ Designated as safety issue: No ]
  • Maximum Concentration (Cmax) at Day 21 (400 mg) [ Time Frame: Day 21 (400 mg) ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: July 2006
Study Completion Date: July 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Suberoylanilide Hydroxamic Acid (600 mg) Drug: Suberoylanilide Hydroxamic Acid (SAHA)
600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest.
Other Names:
  • MK0683
  • vorinostat
Experimental: Suberoylanilide Hydroxamic Acid (400 mg) Drug: Suberoylanilide Hydroxamic Acid (SAHA)
400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days.
Other Names:
  • MK0683
  • vorinostat

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with histologically or cytologically diagnosed solid tumor in whom no standard therapy is available or the malignancy is refractory to standard therapy

Exclusion Criteria:

  • Patients with history of immunotherapy, radiotherapy, surgery, or chemotherapy during the previous 4 weeks
  • Any uncontrolled concomitant illness
  • Pregnant or breast-feeding
  • Serious drug or food allergy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00373490

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

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00373490     History of Changes
Other Study ID Numbers: 2006_030, MK0683-048
Study First Received: September 7, 2006
Results First Received: October 20, 2008
Last Updated: May 20, 2009
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on June 18, 2013