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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 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.
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.
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.
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum tolerated dose (MTD)
Secondary study objectives
Incidence of adverse events
Overall survival
Progression free survival
Other study objectives
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
~1200
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
3,039 Previous Clinical Trials
1,799,662 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,961 Total Patients Enrolled
Shubham PantPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
99 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility 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.Taking certain medications.You need to have certain levels of blood cells and chemicals in your blood.You have at least one visible and measurable abnormality according to specific guidelines.You have received treatment for cancer that has spread to other parts of your body.Tests show that your tumor has a specific mutation called KRAS.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.You have a history of cancer spreading to the brain or spinal cord.You have a history of or are at risk for a certain eye condition called retinal vein occlusion.You currently have a serious infection that needs treatment throughout your body.You have an eye condition that could affect your vision.You have a history of blood clots or stroke.You have had significant bleeding that needed a blood transfusion in the 3 months before screening.You have a history of liver or gallbladder problems caused by drugs.Your ability to perform daily activities has gotten worse in the month before joining the study.You have had a solid organ or blood-related transplant.You have a muscle or nerve condition that causes high levels of creatine kinase.You have mental health or substance abuse issues that could make it hard for you to take part in the trial.Women who could become pregnant must have a negative pregnancy test.You have a blockage in your intestines.You have a stomach or intestine problem that could make it hard for the drug to work in your body.You have had psoriatic arthritis or porphyria, or you cannot safely have a tumor biopsy.You have been diagnosed with pancreatic cancer that has spread to other parts of the body according to specific medical criteria.You have a type of pancreatic tumor that is not adenocarcinoma.You have recently had cancer treatment or a major surgery.You have a heart condition that affects your health.You have a condition that affects how your body absorbs medication in your stomach and intestines.Any health issues or treatments that could make it hard to understand the trial results.You have taken a medication called a MEK or ERK inhibitor before.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (binimetinib, hydroxychloroquine)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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