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Chemotherapy

MK2 Inhibitor + mFOLFIRINOX for Pancreatic Cancer

Phase 1

Waitlist Available

Led By Moh'd Khushman, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age between 18 and 75 years, with ECOG performance status ≤ 1.

Adequate bone marrow and organ function including specific criteria for neutrophil count, platelets, hemoglobin, bilirubin, AST/ALT, and creatinine clearance.

Must not have

Symptomatic interstitial lung disease.

Gastrointestinal conditions preventing absorption of study drug.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through completion of follow-up (estimated to be 3 years)

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to test if blocking MK2 enzyme can make the chemotherapy treatment more effective for patients with pancreatic cancer."

Who is the study for?

This trial is for individuals with untreated metastatic pancreatic ductal adenocarcinoma. Participants should not have had previous treatments for their condition.

What is being tested?

The study tests the combination of a new drug, Zunsemetinib (MK2 inhibitor), with an existing chemotherapy regimen called mFOLFIRINOX to see if it's more effective in treating pancreatic cancer.

What are the potential side effects?

Potential side effects may include typical chemotherapy-related issues such as nausea, fatigue, hair loss, and increased risk of infection. Zunsemetinib-specific side effects are not detailed but could be similar to other drugs targeting cellular pathways.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 75 years old and can carry out all my self-care activities without help.

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My blood counts and organ functions are within normal ranges.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have lung disease that causes symptoms like coughing or shortness of breath.

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I do not have stomach or intestine problems that affect medication absorption.

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I cannot swallow pills.

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My cancer has spread to my brain or central nervous system.

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I have moderate to severe nerve pain or damage.

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I have had an organ or stem cell transplant from a donor.

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I have received FOLFIRINOX treatment for pancreatic cancer.

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I have HIV with a specific CD4+ T-cell count and no history of AIDS.

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I have not had major surgery in the last 28 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through completion of follow-up (estimated to be 3 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through completion of follow-up (estimated to be 3 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of follow-up (estimated to be 3 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Disease control rate (DCR) (only for those treated at RP2D)

Number of participants with adverse events by types

Overall response rate (ORR) (only for those treated at RP2D)

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose expansion phase (zunsemetinib + mFOLFIRNOX)Experimental Treatment2 Interventions

The dose of zunsemetinib will be determined during the dose escalation phase of the trial. mFOLFIRINOX will be 85 mg/m\^2 of oxaliplatin intravenous (IV) on day 1 of each cycle, 150 mg/m\^2 of irinotecan IV on day 1 of each cycle, 400 mg/m\^2 of leucovorin IV on day 1 of each cycle, and 2400 mg/m\^2 continuous infusion starting on day 1 of each cycle and continuing for 46 hours. Each cycle is 2 weeks in length.

Group II: Dose escalation phase (zunsemetinib + mFOLFIRNOX)Experimental Treatment2 Interventions

The dose of zunsemetinib will be determined by the dose level assigned and will be taken by mouth either once or twice daily depending on assigned dose level. mFOLFIRINOX will be 85 mg/m\^2 of oxaliplatin intravenous (IV) on day 1 of each cycle, 150 mg/m\^2 of irinotecan IV on day 1 of each cycle, 400 mg/m\^2 of leucovorin IV on day 1 of each cycle, and 2400 mg/m\^2 continuous infusion starting on day 1 of each cycle and continuing for 46 hours. Each cycle is 2 weeks in length.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

mFOLFIRINOX

2013

Completed Phase 2

~90

0 / 11Eligibility criteria met