A Dose-finding Study of Birabresib (MK-8628) in Participants With Recurrent Glioblastoma Multiforme (MK-8628-002)
Status:
Terminated
Trial end date:
2015-10-20
Target enrollment:
Participant gender:
Summary
A study of single-agent birabresib (MK-8628) (formerly known as OTX015) in recurrent GBM
after standard front-line therapy failure.
The first phase of the study (dose escalation) will determine the maximum tolerated dose
(MTD). MTD assessment will be based using dose-limiting toxicities (DLTs) observed during the
first 28 days of treatment.
The second phase of the study (expansion cohort) will assess efficacy as measured by the
progression-free survival rate at 6 months (PFS-6) as determined by an independent central
review committee.