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

Phase 1

Completed

• Conditions: Advanced Cancer Relapsed; Advanced Cancer Refractory
• Interventions: Drug: vorinostat

• Registration Number: NCT00632931
• Lead Sponsor: Merck Sharp & Dohme LLC

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

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2008-02-29
• Study First Submitted QC: 2008-02-29
• Study First Posted: 2008-03-11
• Primary Completion: 2008-05
• Study Completion: 2009-04
• Results First Submitted: 2010-01-18
• Results First Submitted QC: 2010-01-22
• Results First Posted: 2010-02-15
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-08
• Last Update Posted: 2015-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Patient has a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy or for which standard therapy does not exist
• Patient has life expectancy of greater than 3 months
• Patient is able to swallow capsules

Exclusion Criteria

• Patient has had chemotherapy, radiotherapy or biological therapy 2 weeks prior to taking study drug
• Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent
• Patient has active CNS metastases and/or carcinomatous meningitis
• Patient has primary central nervous system tumor
• Patient has a history of drug or alcohol abuse
• Patient has Hepatitis B or C
• Patient is HIV positive
• Patient has active infection or has received intravenous antibiotics, antiviral or antifungal agents 2 weeks before taking study drug

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	vorinostat	Arm A: Drug/Placebo
B	vorinostat	Arm B: Placebo/Drug

Primary Outcome Measures

Name	Time	Method
Change From Baseline in QTcF at 3 Hours	Baseline and 3 hours	The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.
Change From Baseline in QTcF at 4 Hours	Baseline and 4 hours	The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The placebo-corrected change from baseline in QTcF was calculated by subtracting the QTcF change from baseline for placebo at each timepoint from the QTcF change from baseline for vorinostat at each timepoint.
Change From Baseline in QTcF at 24 Hours	Baseline and 24 hours	The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.
Change From Baseline in QTcF at 0.5 Hours	Baseline and 0.5 hours	The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.
Change From Baseline in QTcF at 1 Hour	Baseline and 1 hour	Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.
Change From Baseline in QTcF at 2 Hours	Baseline and 2 hours	The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.
Change From Baseline in QTcF at 12 Hours	Baseline and 12 hours	The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.
Change From Baseline in QTcF at 8 Hours	Baseline and 8 hours	The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.