This is a multi- center, open-label, dose finding, Phase Ib study to be conducted in two stages: a dose escalation part to determine the maximum tolerated dose (MTD) safety and tolerability of concurrent administration of MEK162 and RAF265, followed by an expansion part to further assess the safety and preliminary anti-tumor efficacy of this oral combination within two separate patient populations: i) patients with advanced solid tumors harboring BRAFV600E mutations or ii) patients with advanced solid tumors harboring RAS mutations.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
69
H. Lee Moffitt Cancer Center & Research Institute Moffitt 4
Tampa, Florida, United States
Oregon Health & Science University OHSU 3
Portland, Oregon, United States
University of Utah / Huntsman Cancer Institute Huntman 2
Salt Lake City, Utah, United States
Pfizer Investigative Site
Edmonton, Alberta, Canada
Pfizer Investigative Site
Montreal, Quebec, Canada
Pfizer Investigative Site
Oslo, Norway
Pfizer Investigative Site
Madrid, Spain
Pfizer Investigative Site
Zurich, Switzerland
Incidence of Dose Limiting Toxicities
Time frame: during the first 28 days of treatment with RAF265 and MEK162
Number of participants with adverse events and serious adverse events
Time frame: 18 months
assess preliminary anti-tumor activity of the combination
CT scan will be performed
Time frame: every 8 weeks of treatment
Tumor skin and blood samples will be collected before and during treatment with RAF265 and MEK162 to assess the combination's effects on the RAF/MEK/MAPK pathway with the clinical outcomes
Time frame: 18 months
Time versus plasma concentration profiles of RAF265 and MEK162
Time frame: 10 months
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