A Phase Ib/II Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma
Status:
Terminated
Trial end date:
2015-05-01
Target enrollment:
Participant gender:
Summary
A phase Ib dose-escalation study of the AEB071 and MEK162 combination in adult patients with
confirmed metastatic uveal melanoma. Cohorts of 3-6 patients will be assessed for dose
limiting toxicities (DLTs) during Cycle 1 until the maximum tolerated dose (MTD) of the
combination therapy is determined. The MTD or Phase 2 Recommended Dose (P2RD) will be used in
a Phase II part of the study, which will enrol 55 patients each into two randomized groups:
the combination therapy or MEK162 alone. The Phase II part will continue until proof of
concept is established. Patients will continue treatment as long as clinical benefit is seen
and no limiting adverse toxicity is observed
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Array BioPharma Array Biopharma, now a wholly owned subsidiary of Pfizer