A Continuation Clinical Trial of Oral Vorinostat (MK-0683) in Advanced Cancers
Overview
- Phase
- Phase 2
- Intervention
- vorinostat
- Conditions
- Advanced Cancer
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 27
- Primary Endpoint
- Percent of Participants With a Serious Drug-related Adverse Event (AE)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Vorinostat
Intervention: vorinostat
Outcomes
Primary Outcomes
Percent of Participants With a Serious Drug-related Adverse Event (AE)
Time Frame: 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.