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

NCT ID: NCT00632931

Last Updated: 2015-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2009-04-30

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

Conditions

Advanced Cancer Relapsed; Advanced Cancer Refractory

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

A

Arm A: Drug/Placebo

Group Type: EXPERIMENTAL

vorinostat

Intervention Type: 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)

Intervention Type: 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).

B

Arm B: Placebo/Drug

Group Type: EXPERIMENTAL

vorinostat

Intervention Type: 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)

Intervention Type: 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).

Interventions

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.

Intervention Type: 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).

Intervention Type: DRUG

Other Intervention Names

MK0683; Zolinza®

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: RESULT

PMID: 19887475 (View on PubMed)

Other Identifiers

MK0683-070

Identifier Type: -

Identifier Source: secondary_id

2008_515

Identifier Type: -

Identifier Source: secondary_id

0683-070

Identifier Type: -

Identifier Source: org_study_id