BRAF/MEK/EGFR Inhibitor Combination Study in Colorectal Cancer (CRC)
Status:
Completed
Trial end date:
2020-06-18
Target enrollment:
Participant gender:
Summary
This was a four part, phase I/II study aimed to evaluate the safety, tolerability and
efficacy of combination of an anti-EGFR antibody panitumumab (P) either with a BRAF inhibitor
(dabrafenib (D); GSK2118436) alone or with the combination of a BRAF inhibitor and a MEK
inhibitor (trametinib (T); GSK1120212) in patients with BRAF-mutant V600E advanced or mCRC.
The goal was to: 1) Determine RP2R/MTD for doublet (D+P) and triplet (D+T+P) combinations in
Part 1; 2) Assess clinical activity for these combinations in Part 2; 3) Determine RP2R/MTD
for double (T+P) combination in Part 4A, and assess clinical activity of this combination in
two patient populations in Part 4B (patients with BRAF-V600E mutation-positive advanced or
metastatic CRC and patients with advanced or metastatic CRC with secondary resistance to
anti-EGFR therapy).