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

Completed · Phase 1/Phase 2

Conditions studied: Metastatic Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT01927341

Run by

Pfizer

People needed

53

Starts

2013-11-19

Expected to finish

2016-01-25

Last updated by the study team

2021-02-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California at Los Angeles Dept of Onc — Los Angeles, California, United States
• Memorial Sloan Kettering Cancer Center Oncology Dept — New York, New York, United States
• Pfizer Investigative Site — Leuven, Belgium
• Pfizer Investigative Site — Toronto, Ontario, Canada
• Pfizer Investigative Site — Toulouse, France
• Pfizer Investigative Site — Milan, MI, Italy
• Pfizer Investigative Site — Amsterdam, Netherlands
• Pfizer Investigative Site — Barcelona, Catalonia, Spain

Full record on ClinicalTrials.gov

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