Clinical trialPhase 1Active not recruiting
Ivosidenib + mFOLFIRINOX in Patients With Resectable Pancreatic Adenocarcinoma
A Phase I, Single-Center, Open-Label, Dose De-escalation and Expansion Study Ivosidenib + mFOLFIRINOX in Patients With Resectable Pancreatic Adenocarcinoma
- Outcome
- Ongoing
- Phase
- Phase 1
- Status
- Active not recruiting
- Study type
- Interventional
- Start
- 8 September 2022
- Expected end
- 31 December 2026
- Enrollment
- 16 participants
- Sites
- 1
- Primary outcomes
- Maximum-tolerated dose (MTD) or Recommended Phase 2 dose (RP2D)
- Sponsor
- Other
- Results posted
- No
- Last update
- 5 September 2025
These are registry fields. A trial card, with population, design, endpoints and result direction each tied to a quote, is not in the data yet.
Ask this document
Answers come only from this document’s own text, as highlighted quotes. If it doesn’t say, you are told so instead of given a guess.
Try
Source text
Brief summary public domain (ClinicalTrials.gov)
This study is a single-arm, phase I trial, up to 16 participants with resectable PDA. The study will examine the efficacy of the mutant IDH1 inhibitor ivosidenib, in conjunction with standard-of-care mFOLFIRINOX in the neoadjuvant setting.
Detailed description public domain (ClinicalTrials.gov)
Currently, the standard of care treatment for resectable PDA is surgical resection followed by adjuvant chemotherapy. The use of mFOLFIRINOX in this setting has extended survival significantly. Giving ivosidenibwith mFOLFIRINOXmay work better than treating participants with mFOLFIRINOX alone.