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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00373490
First received: September 7, 2006
Last updated: June 19, 2014
Last verified: June 2014
  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
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:


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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ 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: 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: September 7, 2006
Results First Received: October 20, 2008
Last Updated: June 19, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on October 23, 2014