A Phase Ib/II, Multicenter, Open-label, Dose Escalation Study of LGX818 in Combination With MEK162 in Adult Patients With BRAF V600 - Dependent Advanced Solid Tumors
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Phase Ib: Estimation of Maximum Tolerated Dose (MTD) by measuring incidence of dose limiting toxicities (DLT)
To estimate the MTD(s) and/or rapid phase 2 dose(s) (RP2D(s)) of oral LGX818 in combination with oral MEK162 in patients with BRAF V600-dependent advanced solid tumors by measuring the incidence of DLTs as defined by the protocol.
up to 8 months
Yes
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
United States: Food and Drug Administration
CMEK162X2110
NCT01543698
May 2012
September 2015
Name | Location |
---|---|
Massachusetts General Hospital Mass General 2 | Boston, Massachusetts 02114 |
MD Anderson Cancer Center/University of Texas MD Univ TX | Houston, Texas 77030-4009 |
The Sidney Kimmel Cancer Center at Johns Hopkins Hospital Johns Hopkins | Baltimore, Maryland 21231 |
H. Lee Moffitt Cancer Center & Research Institute Moffitt SC 2 | Tampa, Florida 33612 |