Clinical Trial of MK0683 in Combination With FDA Approved Cancer Drugs in Patients With Advanced NSCLC (MK0683-058)

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT00423449
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • vorinostat — DRUG
    Dose escalation study: vorinostat 300-500 mg capsules once daily for 7-14 days in continuous cycles of 21 days
  • Gemcitabine — DRUG
    Dose escalation study: Gemcitabine 1000-1250 mg/m2 will be given for 2 days in each 21 day cycle
  • Platinum-based agent — DRUG
    Cisplatin IV 75 mg/m2 will be given for 1 day in each 21 day cycle or carboplatin dosed according to renal function.

Study Details

This is a clinical trial to determine the safety and tolerability of MK0683 in combination with gemcitabine and cisplatin and/or carboplatin.

Key Dates

First listed
Jan 18, 2007
Start date
Mar 31, 2007
Status verified
Feb 2016
Primary completion
Apr 30, 2010
Completion
Apr 30, 2010

Study Design

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

Arms

  • Experimental: Vorinostat + Gemcitabine + Platinum-based agent

Primary Outcome Measure

Number of Participants With Dose-limiting Toxicities (DLT) Due to Vorinostat Administered in Combination With Standard Dose of Gemcitabine Plus Either Cisplatin or Carboplatin [ Time Frame: every 21 days (every cycle), up to 126 days (6 cycles) ]

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