Vorinostat in Combination With Vinorelbine in Patients With Advanced Cancer
Status:
Terminated
Trial end date:
2009-11-01
Target enrollment:
Participant gender:
Summary
This is a multi-center, open-label non-randomized dose-escalation trial of vorinostat given
in combination with vinorelbine. Cohorts will be treated with a fixed dose of vinorelbine
(25mg/m²/week continuously, representing the schedule that has been approved). Patients
eligible will be enrolled into a standard 3+3 design with a starting dose of vorinostat at
200 mg po qd 7/21 (weekly schedule). Then, further dose levels will be explored. Toxicity of
the schedule will be assessed during the first cycle. Patients may receive up to 6 cycles of
study medication. Blood samples will be collected at specified time points to assess
pharmacokinetic endpoints.