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

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT00373490
Phase
PHASE1
Status
Completed

Conditions

  • Tumors

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vorinostat — DRUG
    600 mg daily (300 mg twice daily \[b.i.d.\]) for 3 consecutive days followed by 4 days of rest.
  • Vorinostat — DRUG
    400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days.

Study Details

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.

Key Dates

Start date
Jul 31, 2006
Status verified
Aug 2015
Primary completion
Oct 31, 2007
Completion
Oct 31, 2007

Study Design

Enrollment
16 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Vorinostat 600 mg
    600 mg daily (300 mg twice daily \[b.i.d.\]) for 3 consecutive days followed by 4 days of rest.
  • Experimental: Vorinostat 400 mg
    400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days.

Primary Outcome Measure

Number of Participants With a Dose Limiting Toxicity (DLT) [ Time Frame: 21 Days (first cycle) ]

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