Binimetinib + Hydroxychloroquine for Pancreatic Cancer

Overseen by Shubham Pant, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

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

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

Treatment Details

Interventions

• Binimetinib (MEK Inhibitor)
• Hydroxychloroquine (Autophagy Inhibitor)

Trial Overview The 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

Group I: Treatment (binimetinib, hydroxychloroquine) Experimental Treatment 2 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

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School