A Crossover Study to Assess the Effects of Vorinostat (MK0683, SAHA) in Patients With Advanced Cancer
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00632931
First received: February 29, 2008
Last updated: April 21, 2010
Last verified: April 2010
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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:
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: | July 2008 |
| 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:
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:
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 More Information
Additional Information:
No publications provided
| Responsible Party: | Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00632931 History of Changes |
| Other Study ID Numbers: | 2008_515, MK0683-070 |
| Study First Received: | February 29, 2008 |
| Results First Received: | January 18, 2010 |
| Last Updated: | April 21, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Neoplasms Vorinostat Histone Deacetylase Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013