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A Study of Oral Suberoylanilide Hydroxamic Acid (Vorinostat) in Patients With Solid Tumors (0683-048)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00373490
First Posted: September 8, 2006
Last Update Posted: August 27, 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
This is a clinical study to evaluate the safety and pharmacokinetics of an overseas determined maximum tolerated dose (MTD) of MK-0683 (vorinostat) in a Japanese patient population with solid tumors.

Condition Intervention Phase
Tumors Drug: Vorinostat Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MK0683 Phase1 Clinical Study - Solid Tumor -

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Participants With a Dose Limiting Toxicity (DLT) [ Time Frame: 21 Days (first cycle) ]
    Dose Limiting Toxicity = Drug-related side effects that are serious enough to prevent an increase in dose or level of that treatment


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) ]
    Area Under Curve (AUC(0-infinity))=Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (o- ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). At 600 mg, t=12 hours and at 400 mg, t=24 hours.

  • Area Under the Curve (AUC(0-infinity)) at Day 3 (600 mg) [ Time Frame: Day 3 (600 mg) ]
    Area Under Curve (AUC(0-infinity))=Area under the plasma concentration versus time curve (AUC) from time zero to 24 hours. It is obtained from AUC (0 - 12) plus AUC (12 - ∞)

  • Area Under the Curve (AUC(0-infinity) at Day 21 (400 mg) [ Time Frame: Day 21 (400 mg) ]
    Area Under Curve (AUC(0-infinity))=Area under the plasma concentration versus time curve (AUC) from time zero to 24 hours. It is obtained from AUC (0 - 24) plus AUC (24 - ∞)

  • Maximum Concentration (Cmax) at Day 1 (600 mg and 400 mg) [ Time Frame: Day 1 (600 mg and 400 mg) ]
  • Maximum Concentration (Cmax) at Day 3 (600 mg) [ Time Frame: Day 3 (600 mg) ]
  • Maximum Concentration (Cmax) at Day 21 (400 mg) [ Time Frame: Day 21 (400 mg) ]

Enrollment: 16
Study Start Date: July 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vorinostat 600 mg
600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest.
Drug: Vorinostat
600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest.
Other Names:
  • MK-0683
  • Suberoylanilide Hydroxamic Acid (SAHA)
Experimental: Vorinostat 400 mg
400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days.
Drug: Vorinostat
400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days.
Other Names:
  • MK-0683
  • Suberoylanilide Hydroxamic Acid (SAHA)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT00373490


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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00373490     History of Changes
Other Study ID Numbers: 0683-048
MK0683-048
2006_030
First Submitted: September 7, 2006
First Posted: September 8, 2006
Results First Submitted: October 20, 2008
Results First Posted: May 20, 2009
Last Update Posted: August 27, 2015
Last Verified: August 2015

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