Binimetinib and Hydroxychloroquine in Treating Patients With KRAS Mutant Metastatic Pancreatic Cancer

Summary

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Description

PRIMARY OBJECTIVE: I. To determine the maximum tolerated dose of hydroxychloroquine (HCQ) when combined with a fixed dose of binimetinib. SECONDARY OBJECTIVES: I. To determine the response rate among a pilot cohort of pancreatic cancer patients. II. To determine the safety and toxicity profile of th...

PRIMARY OBJECTIVE: I. To determine the maximum tolerated dose of hydroxychloroquine (HCQ) when combined with a fixed dose of binimetinib. SECONDARY OBJECTIVES: I. To determine the response rate among a pilot cohort of pancreatic cancer patients. II. To determine the safety and toxicity profile of the combination of binimetinib and HCQ. III. To determine the ability of the combination to halt tumor growth as measured by progression free survival. IV. To assess the overall survival of patients treated on this regimen. EXPLORATORY OBJECTIVES: I. To compare the efficacy of treatment to somatic gene mutation profile as acquired by standard of care testing. II. To assess pre- and post- treatment tissue to determine if markers of autophagy correlate with response to treatment. III. To assess the effect of this binimetinib/HCQ treatment on changes in muscle and fat mass as analyzed by computed tomography (CT) scan (as standard of care treatment). OUTLINE: This is a dose-escalation study of hydroxychloroquine. Patients receive binimetinib orally (PO) twice daily (BID) and hydroxychloroquine PO BID on days 1-14. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 30 days.

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