Clinical trial · Interventional
A Crossover Study to Assess the Effects of Vorinostat (MK0683, SAHA) in Patients With Advanced Cancer (0683-070)(COMPLETED)
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
NCT00632931CI-TRIAL-00018722completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer Refractory | — | UNRESOLVED | — |
| Advanced Cancer Relapsed | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Comparator: placebo (unspecified) | Drug | — | UNRESOLVED |
| vorinostat | Drug | Vorinostat | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- Arm A: Drug/Placebo
- interventionNames
- Drug: vorinostat
- Drug: Comparator: placebo (unspecified)
- type
- EXPERIMENTAL
- label
- B
- description
- Arm B: Placebo/Drug
- interventionNames
- Drug: vorinostat
- Drug: Comparator: placebo (unspecified)
Primary outcomes (8)
- measure
- Change From Baseline in QTcF at 0.5 Hours
- timeFrame
- Baseline and 0.5 hours
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTMunster 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