What side effects are associated with this type of intervention?

Hydroxychloroquine, used for autophagy inhibition, can cause side effects such as gastrointestinal disturbances, skin rashes, and, in rare cases, retinal toxicity. Binimetinib, an enzyme inhibitor, may lead to side effects including fatigue, rash, diarrhea, and elevated liver enzymes. Common treatments for pancreatic cancer, such as chemotherapy, often result in side effects like nausea, vomiting, fatigue, and increased risk of infection due to lowered blood cell counts.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer, though specific approvals for autophagy inhibitors like hydroxychloroquine and enzyme inhibitors like binimetinib are still under investigation. Historically, treatments have included chemotherapeutic agents such as gemcitabine and targeted therapies like erlotinib, which inhibits the epidermal growth factor receptor (EGFR). More recently, the FDA has approved combination therapies like FOLFIRINOX (a regimen including fluorouracil, leucovorin, irinotecan, and oxaliplatin) and nab-paclitaxel with gemcitabine. These treatments focus on different mechanisms, including DNA synthesis inhibition and microtubule stabilization, rather than autophagy or specific enzyme inhibition.

What other types of research exist?

Promising novel alternatives for pancreatic cancer treatment in 2024 include: 1) PARP inhibitors like Olaparib for patients with BRCA mutations, which target DNA repair mechanisms. 2) Immunotherapy agents such as Pembrolizumab, especially for tumors with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR). 3) KRAS G12C inhibitors like Sotorasib, which directly target the KRAS mutation. 4) Combination therapies involving novel agents like CDK4/6 inhibitors (e.g., Palbociclib) with other targeted therapies or chemotherapy.

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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

No Placebo-Only Group

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

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

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~5350

Binimetinib

2018

Completed Phase 3

~1250

Do I qualify?Apply below to find out

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.