Conditions: Metastatic Colorectal Cancer
Keywords: MEK162, panitumumab, mutant RAS, wild-type RAS, metastatic colorectal cancer, adult mCRC patient
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 53
Healthy volunteers: no

Brief summary:
The primary purpose of the phase Ib is to estimate the MTD/RPD2 and of the phase II is to assess the anti-tumor activity of MEK162 in combination with panitumumab.

Detailed description:

Arms:
arm 1: Phase Ib: Dose escalation. arm 2: Patients with mutant RAS mCRC who have not been pretreated with an EGFR inhibitor (EGFRi), including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy. arm 3: Patients with acquired mutant RAS mCRC who have been pretreated with anti-EGFR monoclonal antibody therapy, but have not been pre-treated with EGFR tyrosine kinase inhibitor therapy. arm 4: Patients with WT RAS mCRC who have been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy. arm 5: Patients with WT RAS mCRC who have not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy.

Interventions: intervention 1: MEK162 intervention 2: Panitumumab
Intervention descriptions: intervention 1: Tablet for oral use, 45 mg (three 15 mg tablets), BID intervention 2: Intravenous infusion, 20mg/ml concentrate solution for infusion, Q2W (Days 1 and 15 of every cycle)

Protocol document: