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

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ClinicalTrials.gov Identifier: NCT00373490
Recruitment Status : Completed
First Posted : September 8, 2006
Results First Posted : May 20, 2009
Last Update Posted : August 27, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Tumors Drug: Vorinostat Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MK0683 Phase1 Clinical Study - Solid Tumor -
Study Start Date : July 2006
Primary Completion Date : October 2007
Study Completion Date : October 2007

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: 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)


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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 - ∞)

  3. 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 - ∞)

  4. Maximum Concentration (Cmax) at Day 1 (600 mg and 400 mg) [ Time Frame: Day 1 (600 mg and 400 mg) ]
  5. Maximum Concentration (Cmax) at Day 3 (600 mg) [ Time Frame: Day 3 (600 mg) ]
  6. Maximum Concentration (Cmax) at Day 21 (400 mg) [ Time Frame: Day 21 (400 mg) ]

Eligibility Criteria

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 Posted: September 8, 2006    Key Record Dates
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