Trials / Terminated
TerminatedNCT02296476
A Dose-finding Study of Birabresib (MK-8628) in Participants With Recurrent Glioblastoma Multiforme (MK-8628-002)
A Phase IIa Trial With Dose Optimization of OTX015, a Small Molecule Inhibitor of the Bromodomain and Extra-terminal (BET) Proteins, in Recurrent Glioblastoma Multiforme (GBM) Patients
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Oncoethix GmbH, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Birabresib | Administered orally in a fasted state once daily. |
Timeline
- Start date
- 2014-10-29
- Primary completion
- 2015-10-20
- Completion
- 2015-10-20
- First posted
- 2014-11-20
- Last updated
- 2021-01-26
- Results posted
- 2018-05-17
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02296476. Inclusion in this directory is not an endorsement.