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Metabolic Inhibitor

Expansion Cohort A for Pancreatic Cancer

Phase 1 & 2

Waitlist Available

Led By Vaibhav Sahai

Research Sponsored by University of Michigan Rogel 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 25 months after enrollment

Awards & highlights

Study Summary

This trial tests a new cancer treatment on patients with metastatic pancreatic cancer. Patients will be randomly assigned to different doses.

Eligible Conditions

Pancreatic Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 25 months after enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 25 months after enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 25 months after enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Median Progression Free Survival (PFS) of devimistat plus modified FOLFIRINOX across all cohorts

Number of subjects with dose-limiting toxicity during the first 15 days of devimistat in combination with modified FOLFIRINOX in the dose escalation cohort

Secondary outcome measures

Duration of response (DoR) of devimistat plus modified FOLFIRINOX

Number of subjects with reported adverse events and reportable serious events

Overall Response Rate (ORR) of devimistat plus modified FOLFIRINOX

+9 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: TiTE-CRM Dose EscalationExperimental Treatment2 Interventions

Devimistat at Dose Level IV 2 hrs + modified FOLFIRINOX

Group II: Expansion Cohort BExperimental Treatment2 Interventions

Devimistat at MTD IV 4 hrs + modified FOLFIRINOX

Group III: Expansion Cohort AExperimental Treatment2 Interventions

Devimistat 500 mg/m2 IV 2 hrs + modified FOLFIRINOX

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Modified FOLFIRINOX

2011

Completed Phase 1

~20

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Michigan Rogel Cancer CenterLead Sponsor

293 Previous Clinical Trials

24,097 Total Patients Enrolled

Vaibhav SahaiPrincipal InvestigatorUniversity of Michigan Rogel Cancer Center

1 Previous Clinical Trials

66 Total Patients Enrolled

Frequently Asked Questions

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

Has the recruitment process for this experiment already begun?

"According to clinicaltrials.gov, this particular medical study is not currently recruiting patients. Initially posted on July 1st 2023 and most recently updated June 26th, 2023 - while it may open up for enrollment at a later date, there are still 779 other trials actively seeking participants."

Answered by AI

What outcome is this experiment designed to elicit?

"This clinical trial, which will yield results 15 days after the start of combined therapy, aims to analyze Median Progression Free Survival (PFS) associated with devimistat plus modified FOLFIRINOX across all cohorts. Secondary outcomes involve an Overall Response Rate (ORR) and Overall Survival (OS) based on gender as determined by RECISTv1.1 criteria from initial treatment till either date of death or censoring."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trial of Devimistat in Combination With Modified FOLFIRINOX in Patients With Metastatic Adenocarcinoma of the Pancreas

2023. "Trial of Devimistat in Combination With Modified FOLFIRINOX in Patients With Metastatic Adenocarcinoma of the Pancreas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05926206.