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

NCT00632931 | Completed Phase 1 Results

• 3 other identifiers: 0683-070MK0683-0702008_515
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Advanced Cancer Relapsed; Advanced Cancer Refractory

Outcome Measures

Primary Outcomes (8)

• Change From Baseline in QTcF at 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.

  Baseline and 0.5 hours

• Change From Baseline in QTcF at 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.

  Baseline and 1 hour

• Change From Baseline in QTcF at 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.

  Baseline and 2 hours

• Change From Baseline in QTcF at 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.

  Baseline and 3 hours

• Change From Baseline in QTcF at 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.

  Baseline and 4 hours

• Change From Baseline in QTcF at 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.

  Baseline and 8 hours

• Change From Baseline in QTcF at 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.

  Baseline and 12 hours

• Change From Baseline in QTcF at 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.

  Baseline and 24 hours

Study Arms (2)

A

EXPERIMENTAL

Arm A: Drug/Placebo

Drug: vorinostat; Drug: Comparator: placebo (unspecified)

B

EXPERIMENTAL

Arm B: Placebo/Drug

Drug: vorinostat; Drug: Comparator: placebo (unspecified)

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.

Also known as: MK0683, Zolinza®

A; B

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).

A; B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Munster PN, Rubin EH, Van Belle S, Friedman E, Patterson JK, Van Dyck K, Li X, Comisar W, Chodakewitz JA, Wagner JA, Iwamoto M. A single supratherapeutic dose of vorinostat does not prolong the QTc interval in patients with advanced cancer. Clin Cancer Res. 2009 Nov 15;15(22):7077-84. doi: 10.1158/1078-0432.CCR-09-1214. Epub 2009 Nov 3.

  PMID: 19887475 RESULT

MeSH Terms

Interventions

Vorinostat

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Hydroxamic Acids; Hydroxylamines; Hydroxy Acids; Carboxylic Acids

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

clinicaltrialsdisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2008
• First Posted: March 11, 2008
• Study Start: July 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: April 1, 2009
• Last Updated: July 30, 2015
• Results First Posted: February 15, 2010

Record last verified: 2015-07