A Crossover Study to Assess the Effects of Vorinostat (MK0683, SAHA) in Patients With Advanced Cancer (0683-070)(COMPLETED)

Conditions

• Advanced Cancer Refractory
• Advanced Cancer Relapsed

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• vorinostat — DRUG
  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.
• Comparator: placebo (unspecified) — DRUG
  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).

Study Details

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

Key Dates

Start date

Jul 31, 2007

Status verified

Jul 2015

Primary completion

May 31, 2008

Completion

Apr 30, 2009

Study Design

Enrollment

25 participants (actual)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: A
  Arm A: Drug/Placebo
• Experimental: B
  Arm B: Placebo/Drug

Primary Outcome Measure

Change From Baseline in QTcF at 0.5 Hours [ Time Frame: Baseline and 0.5 hours ]