Clinical trialPhase 1 / Phase 2Withdrawn
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
- Outcome
- Stopped earlybased some additional data, we have decided to hold off this trial for now and will not be proceeding with this particular trial (Other)
- Phase
- Phase 1 / Phase 2
- Status
- Withdrawn
- Study type
- Interventional
- Start
- July 2023
- Expected end
- January 2027
- Enrollment
- 0 participants
- Sites
- 1
- Primary outcomes
- Number of subjects with dose-limiting toxicity during the first 15 days of devimistat in combination with modified FOLFIRINOX in the dose escalation cohort; Median Progression Free Survival (PFS) of devimistat plus modified FOLFIRINOX across all cohorts
- Sponsor
- Other
- Results posted
- No
- Last update
- 2 August 2023
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Source text
Brief summary public domain (ClinicalTrials.gov)
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.