A Phase Ib/II, Open-label, Multicenter Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase I: dose limiting toxicity (DLT)
A DLT is defined as an adverse event or abnormal laboratory value as defined in the protocol that is assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first 28 days of treatment with AEB071and MEK162.
Up to 28 days of treatment with AEB071 and MEK162
Yes
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
European Union: European Medicines Agency
CMEK162X2203
NCT01801358
July 2013
March 2015
Name | Location |
---|---|
Dana Farber Cancer Institute Dept. Onc | Boston, Massachusetts 02115 |
Memorial Sloan Kettering Cancer Center Dept of Onc.. | New York, New York 10021 |