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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
At least one measurable lesion by RECIST criteria
Prior treatment with at least one line of therapy for metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Study 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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have at least one visible and measurable abnormality according to specific guidelines.
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You have received treatment for cancer that has spread to other parts of your body.
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You are able to carry out all your normal activities without any restrictions, or you are limited in physically strenuous activity but can still do light work.

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
Binimetinib
2018
Completed Phase 3
~1100
Hydroxychloroquine
2017
Completed Phase 4
~5630

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,300 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,603 Previous Clinical Trials
40,913,236 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities available to participants in this research trial?

"According to clinicaltrials.gov, this research is actively seeking participants. Initially posted on October 22nd 2019 and most recently updated on July 13th 2022, the trial is open for enrollment now."

Answered by AI

What is the maximum capacity of participants for this trial?

"Affirmative. The details on clinicaltrials.gov suggest that this trial is currently enrolling participants, having been first posted in October of 2019 and last updated in July 2022. 39 individuals are being recruited from a single research centre for the study."

Answered by AI

Has Binimetinib been granted authorization by the FDA?

"Due to the preliminary nature of Binimetinib's clinical data, our team assessed it with a score of 1. This is in keeping with Phase 1 trials which provide limited evidence regarding safety and efficacy."

Answered by AI

What maladies is Binimetinib typically used to treat?

"Binimetinib is a popular therapeutic option for metastatic melanoma and other diseases such as unresectable melanoma, malaria, sjögren's syndrome."

Answered by AI

What other investigations have been conducted regarding Binimetinib's efficacy?

"Presently, there are 121 trials exploring the potential of Binimetinib with 10 being in Phase 3. Although Cambridge is home to the majority of these experiments, 3857 different centres globally have active clinical trials relating to this drug."

Answered by AI
~7 spots leftby Mar 2025