Conditions: Advanced Cancer Relapsed Advanced Cancer Refractory
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 25
Healthy volunteers: no

Brief summary:
A 2-period, crossover study to assess the effects of MK0683 (vorinostat) on the QTc interval in patients with relapsed or refractory advanced cancer.

Detailed description:
Merck Duration of Treatment : vorinostat; treatment will continue until disease progression or intolerable toxicity is reached

Arms:
arm 1: Arm A: Drug/Placebo arm 2: Arm B: Placebo/Drug

Interventions: intervention 1: vorinostat intervention 2: Comparator: placebo (unspecified)
Intervention descriptions: intervention 1: A 2-part, crossover study. Part 1: Arm A: Single dose of vorinostat 800 mg capsules (Period 1) crossing over to Single dose of vorinostat Placebo capsules (Period 2) Arm B: Single dose of vorinostat Placebo capsules (Period 1) crossing over to Single dose of vorinostat 800 mg capsules (Period 2). Part 2: All patients will receive 400 mg vorinostat capsules once daily. Treatment will continue until disease progression or intolerable toxicity. intervention 2: A 2-part, crossover study. Part 1: Arm A: Single dose of vorinostat Placebo capsules (Period 2) Arm B: Single dose of vorinostat Placebo capsules (Period 1).

Protocol document: