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MEK Inhibitor

Binimetinib + Hydroxychloroquine for Pancreatic Cancer

Phase 1
Recruiting
Led By Shubham Pant
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Summary

This trial is testing a combination of two drugs to treat patients with pancreatic cancer that has spread to other parts of the body. The first drug, binimetinib, works by blocking some of the enzymes needed for cell growth. The second drug, hydroxychloroquine, may prevent a process called autophagy, where cells destroy proteins and other substances. Autophagy may protect tumor cells by destroying anticancer drugs or substances taken up by them. Giving hydroxychloroquine together with binimetinib may work better in treating patients with pancreatic cancer compared to binimetinib alone.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects include vision problems like retinal vein occlusion, liver issues, infections requiring systemic therapy, bleeding events needing transfusion within three months before screening, gastrointestinal impairments affecting drug absorption.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose (MTD)
Secondary outcome measures
Incidence of adverse events
Overall survival
Progression free survival
+1 more
Other outcome measures
Effect of this binimetinib/hydroxychloroquine treatment on changes in muscle and fat mass
Markers of autophagy
Somatic gene mutation profile

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydroxychloroquine
2017
Completed Phase 4
~5360
Binimetinib
2018
Completed Phase 3
~1100

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Hydroxychloroquine inhibits autophagy, a cellular process that can protect cancer cells by degrading anticancer drugs, thereby potentially making cancer cells more susceptible to treatment. Binimetinib inhibits specific enzymes required for tumor cell growth, thereby preventing the proliferation of cancer cells. These mechanisms are significant for pancreatic cancer patients as they offer targeted approaches to disrupt cancer cell survival and growth, potentially improving treatment outcomes.

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,002 Previous Clinical Trials
1,794,240 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,362 Total Patients Enrolled
Shubham PantPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
92 Total Patients Enrolled

Media Library

Binimetinib (MEK Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04132505 — Phase 1
Pancreatic Cancer Research Study Groups: Treatment (binimetinib, hydroxychloroquine)
Pancreatic Cancer Clinical Trial 2023: Binimetinib Highlights & Side Effects. Trial Name: NCT04132505 — Phase 1
Binimetinib (MEK Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04132505 — Phase 1
~13 spots leftby Dec 2026