A Continuation Clinical Trial of Oral Vorinostat (MK-0683) in Advanced Cancers (MK-0683-007)
- Registration Number
- NCT00907738
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
This study will evaluate the safety and tolerability of continuing vorinostat (MK-0683) dosing in cancer patients previously enrolled in one of five base studies (MK-0683-001, MK-0683-006, MK-0683-008, MK-0683-012, or MK-0683-013) who have shown benefit from receiving this drug.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
Inclusion Criteria
- Patient participated in one of the five vorinostat base protocols, has not shown tumor progression on that study, and has tolerated the study drug
- Patient did not withdraw from the base protocol
- Patient agrees to practice effective birth control during the study
Exclusion Criteria
- Patient is receiving other standard and/or investigational anticancer therapy
- Patient has any condition or disease that would interfere with compliance or pose addition risk in administering the study drug
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Vorinostat vorinostat -
- Primary Outcome Measures
Name Time Method Percent of Participants With a Serious Drug-related Adverse Event (AE) From the first dose of study drug until the patient experiences disease progression, withdraws consent, or develops unacceptable toxicity (from Day 1 up to 4 years and 9 months) A serious adverse event (SAE) was any AE occurring at any dose that resulted in death, was life-threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, or was an overdose.
A drug-related SAE was one that was thought to be possibly, probably, or definitely related to the study drug.
- Secondary Outcome Measures
Name Time Method