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).
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Number of Participants With Adverse Events
Timeframe: From study treatment start date till 30 days safety follow-up, assessed up to approximately 90 months
Overall Response Rate (ORR)
Timeframe: From study treatment start date until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 90 months
Part 3: Progression Free Survival (PFS)
Timeframe: From study treatment start date until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 90 months