Advanced Cancer Refractory Clinical Trial
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
| Verified date | July 2015 |
| Source | Merck Sharp & Dohme Corp. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
A 2-period, crossover study to assess the effects of MK0683 (vorinostat) on the QTc interval in patients with relapsed or refractory advanced cancer.
| Status | Completed |
| Enrollment | 25 |
| Est. completion date | April 2009 |
| Est. primary completion date | May 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme Corp. |
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 Re — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |
| Primary | 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 | Yes |
| Primary | 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 | Yes |
| Primary | 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 | Yes |
| Primary | 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 | Yes |
| Primary | 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 | Yes |
| Primary | 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 | Yes |
| Primary | 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 | Yes |