NCT05926206

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

A Multicenter Open-Label Dose Optimization Trial of Devimistat in Combination With Modified FOLFIRINOX in Patients With Metastatic Adenocarcinoma of the Pancreas

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This protocol will enroll patients with metastatic pancreatic cancer to receive modified FOLFIRINOX plus devimistat. Patients will be enrolled with 1:1 randomization between Dose Escalation Cohort and Cohort A until required 20 patients have been enrolled on Cohort A following which randomization will end and patients will be enrolled without randomization to Dose Escalation Cohort and then subsequently to Cohort B.

Conditions

• Metastatic Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Devimistat	Escalation: Assigned dose level (mg/m2), IV over 120 minutes, Days 1 and 3 Cohort A: 500 mg/m2, IV over 120 minutes, Days 1 and 3 Cohort B: MTD mg/m2, IV over 240 minutes, Days 1 and 3
DRUG	Modified FOLFIRINOX	Oxaliplatin- 85 mg/m2, IV over 120 minutes, day 1 Leucovorin/folinic acid- 400 mg/m2, IV over 90 minutes, day 1 Irinotecan- 150 mg/m2, IV over 90 minutes, day 1 5FU- 2400 mg/m2, IV over 42-48 hours after irinotecan, day 1

Timeline

• Start date: 2023-07-01
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2023-07-03
• Last updated: 2023-08-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study