Phase Ib/II Study of Efficacy and Safety of MEK162 and Panitumumab, in Adult mCRC Patients With Mutant or Wild-type RAS Tumors

• Status: Completed
• Trial end date: 2016-01-25
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Array BioPharma; Pfizer
• Treatments: Antibodies, Monoclonal; Cetuximab; Panitumumab

Criteria

Inclusion Criteria:

• Age ≥ 18 years

• Metastatic colorectal cancer

• Progression on or following standard therapy, or no standard therapy (phase Ib). Progression on or following at least 2-prior fluoropyrimidine-containing chemotherapy regimens (phase II)

• Written documentation of mutant or wild-type RAS

• Life expectancy ≥ 3 months

• ECOG performance status ≤ 2

Exclusion Criteria:

Phase II arms 1 and 4 only: previous treatment with cetuximab, panitumumab, and/or other EGFR inhibitors

• Previous treatment with MEK-inhibitors

• History of severe infusion reactions to monoclonal antibodies.

• Symptomatic or untreated leptomeningeal disease

• Symptomatic brain metastasis

• Current evidence of retinal disease; history of CSR, RVO or ophthalmopathy as assessed by ophthalmologic examination at baseline that would be considered a risk factor for CSR/RVO and history of keratitis.

• Acute or chronic pancreatitis

• Clinically significant cardiac disease

• Not adequate hematologic, renal and hepatic function