Spots Global Cancer Trial Database for Ivosidenib + mFOLFIRINOX in Patients With Resectable Pancreatic Adenocarcinoma
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Trial Identification
Brief Title: Ivosidenib + mFOLFIRINOX in Patients With Resectable Pancreatic Adenocarcinoma
Official Title: A Phase I, Single-Center, Open-Label, Dose De-escalation and Expansion Study Ivosidenib + mFOLFIRINOX in Patients With Resectable Pancreatic Adenocarcinoma
Study ID: NCT05209074
Study Description
Brief Summary: 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: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States
Contact Details
Name: David Bajor, MD
Affiliation: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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