Trial Summary
What is the purpose of this trial?
This trial tests the best dose of hydroxychloroquine combined with binimetinib for treating advanced pancreatic cancer with a KRAS mutation. Binimetinib stops cancer cells from growing, while hydroxychloroquine prevents them from protecting themselves. The goal is to find a more effective treatment for these patients.
Research Team
Shubham Pant, MD
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for adults with metastatic pancreatic cancer that has a KRAS mutation. They must have had at least one prior treatment, be in good physical condition (ECOG 0 or 1), and meet certain blood criteria. Women of childbearing age need a negative pregnancy test and agree to use contraception, as do men.Inclusion Criteria
You need to have certain levels of blood cells and chemicals in your blood.
Ability to be compliant with scheduled visits, treatment plan, and study procedures
Willing and able to provide written informed consent for the trial
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Exclusion Criteria
You have been using steroids for a long time to manage pain or nausea.
You have certain liver diseases, active tuberculosis, or can't handle imaging tests.
Participation in or use of investigational agent within 2 weeks prior to the anticipated first dose of study treatment
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Treatment Details
Interventions
- Binimetinib (MEK Inhibitor)
- Hydroxychloroquine (Autophagy Inhibitor)
Trial OverviewThe trial is testing the combination of Binimetinib, which blocks enzymes for cell growth, with Hydroxychloroquine, which may disrupt tumor cells' survival mechanisms. It aims to find the best dose when used together against advanced pancreatic cancer.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment (binimetinib, hydroxychloroquine)Experimental Treatment2 Interventions
Patients receive binimetinib PO BID and hydroxychloroquine PO BID on days 1-14. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Binimetinib is already approved in Canada, Japan for the following indications:
Approved in Canada as Mektovi for:
- Unresectable or metastatic melanoma with a BRAF V600E or V600K mutation
Approved in Japan as Mektovi for:
- Unresectable or metastatic melanoma with a BRAF V600 mutation
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Trials
3,107
Recruited
1,813,000+
National Cancer Institute (NCI)
Collaborator
Trials
14,080
Recruited
41,180,000+