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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Ivosidenibflat dose (250mgor 500mg) daily on day 1 of a 14 day cycle.
mFOLFIRINOX on days 1-3 of a 14-day cycle. Surgical resection after up to ninety (90) days of treatment.
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Maximum-tolerated dose (MTD) or Recommended Phase 2 dose (RP2D)
Evaluate by the Bayesian optimal interval (BOIN) strategy to identify the MTD.
Time frame: Up to 24 months from the start of treatment
RECIST version 1.1 response rates.
Number of participants with the progression-free occurrence.
Time frame: Up to 24 weeks from the start of treatment
Major pathologic response rates
Number of participants in whom historical treatment's response rate of 10%
Time frame: Up to 24 weeks from the start of treatment
Biochemical response rates
Number of participants with normalization of serum tumor markers during treatment and after surgery.
Time frame: Up to 24 weeks from the start of treatment
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