Ivosidenib + mFOLFIRINOX in Patients With Resectable Pancreatic Adenocarcinoma (NCT05209074) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Ivosidenib + mFOLFIRINOX in Patients With Resectable Pancreatic Adenocarcinoma
United States16 participantsStarted 2022-09-08
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects must have histologicallyor cytologically confirmed diagnosis of pancreatic adenocarcinomaor adenosquamous carcinoma.
* Subjects must have resectable right-sided (head/neck/uncinate) pancreatic cancer based on CT or MRI imaging (pancreas protocol CT of the abdomen and pelvis if possible, MRI with contrast or CT with IV contrast in the absence of a pancreas protocol CT scan, CT of the chest with or without contrast) as determined by the PI or Co-investigators. Participants with contrast allergies may be permitted without contrastscans if approved by the PI or Co-Investigators for safety reasons.
* Male or female subjects age \>18 years of age.
* Eastern Cooperative Oncology Group (ECOG) Performance status being 0-1 within 2 weeks of planned start of therapy.
* Subjects must have normal organ and marrow function as defined below within 2 weeks of C1D1:
* Adequate hematologic (white blood cell \[WBC\] ≥ 3500 cells/mm3; platelet count ≥100,000 cells/mm3; absolute neutrophil count \[ANC\] ≥1500 cells/mm3; and hemoglobin ≥8 g/dL).
* Adequate hepatic function (aspartate aminotransferase \[AST/SGOT\] \<3x upper normal limit \[UNL\], alanine aminotransferase \[ALT/SGPT\] \<3x UNL, bilirubin \<3x UNL).
* Adequate renal function (serum creatinine \<2.0 mg/dL or 177 μmol/L).
* Adequate coagulation ("International Normalized Ratio" or INR must be \<1.5) unless on therapeutic blood thinners.
* Screening HgbA1C \< 7.0%
* Expected survival ≥3 months in the view…
What they're measuring
1
Maximum-tolerated dose (MTD) or Recommended Phase 2 dose (RP2D)
Timeframe: Up to 24 months from the start of treatment