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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00632931
First received: February 29, 2008
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Advanced Cancer Relapsed
Advanced Cancer Refractory
Drug: vorinostat
Drug: Comparator: placebo (unspecified)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized, Partially-Blind, Placebo-Controlled, 2-Period Crossover Study to Assess the Effects of a Single Dose of Vorinostat on the QTc Interval in Patients With Advanced Cancer

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change From Baseline in QTcF at 0.5 Hours [ Time Frame: Baseline and 0.5 hours ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline and 1 hour ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline and 2 hours ] [ Designated as safety issue: Yes ]
    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 3 Hours [ Time Frame: Baseline and 3 hours ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline and 4 hours ] [ Designated as safety issue: Yes ]
    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 8 Hours [ Time Frame: Baseline and 8 hours ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline and 12 hours ] [ Designated as safety issue: Yes ]
    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 24 Hours [ Time Frame: Baseline and 24 hours ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 25
Study Start Date: June 2007
Study Completion Date: April 2009
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Arm A: Drug/Placebo
Drug: vorinostat
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.
Other Names:
  • MK0683
  • Zolinza®
Drug: Comparator: placebo (unspecified)
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).
Experimental: B
Arm B: Placebo/Drug
Drug: vorinostat
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.
Other Names:
  • MK0683
  • Zolinza®
Drug: Comparator: placebo (unspecified)
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).

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00632931

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00632931     History of Changes
Other Study ID Numbers: 0683-070, MK0683-070, 2008_515
Study First Received: February 29, 2008
Results First Received: January 18, 2010
Last Updated: July 15, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Vorinostat
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014