MEK Inhibitor MSC1936369B Plus FOLFIRI in Second Line K-Ras Mutated Metastatic Colorectal Cancer (mCRC)
Status:
Terminated
Trial end date:
2012-04-01
Target enrollment:
Participant gender:
Summary
The research trial is testing the experimental treatment pimasertib (MSC1936369B) in
combination with FOLFIRI, as second-line treatment in metastatic K Ras mutated colorectal
cancer subjects. The study will be run in two parts:
Part 1, or Safety Run-in Part: Will determine the maximum tolerated dose and the recommended
Phase 2 dose (RP2D) of pimasertib combined with FOLFIRI as second-line treatment in subjects
with metastatic K Ras mutated colorectal cancer.
Part 2 or Phase 2 Randomised Part: Will assess the anti-tumor activity of pimasertib combined
with FOLFIRI compared to FOLFIRI with placebo as second-line treatment in metastatic K Ras
mutated colorectal cancer subjects.
Phase I which Is an open label dose escalation "3+3" cohort, non-randomized, safety Phase II
which is a double blind randomized safety/efficacy