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Ivosidenib + mFOLFIRINOX in Patients With Resectable Pancreatic Adenocarcinoma | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1

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

NCT05209074•Case Comprehensive Cancer Center

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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%
+7 more criteria

Exclusion Criteria

•Subjects under the age of 18yearsof age.
•Subjects with unresectablepancreatic canceror resectableleft-sided (body/tail) pancreatic cancer
•Subjects with endocrine or acinar pancreatic carcinoma.
•Subjects with locally advanced or recurrentpancreatic cancer.
•Subjects with metastatic pancreatic cancer based on imaging.
•Subjects who have received prior radiation therapy, surgical or medical treatment for pancreatic cancer.
•Subjects receiving any other standard or investigational treatment for their PDA.
•Pregnant women or breast feeding women, or women of child-bearing potential not using reliable means of contraception are excluded from this study because the teratogenic or abortifacient effects of ivosidenibis unknown. Because there is an unknown, but potential risk for adverse events in nursinginfants secondary to treatment of the mother with ivosidenib, breastfeeding should be discontinued if the mother is treated withivosidenib. These potential risks may also apply to other agents used in this study.
•Fertile men unwilling to practice contraceptive methods during the study period.
•Subjects with a life expectancy less than 3 months.
+5 more criteria

Locations (1)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Key Dates

Start Date

September 8, 2022

Primary Completion Date

July 15, 2026

Completion Date

December 31, 2026

Last Updated

September 5, 2025

Enrollment

ACTUAL participants

Conditions

Pancreatic Ductal AdenocarcinomaResectable Pancreatic Cancer

Interventions

Ivosidenib

DRUG

mFOLFIRINOX

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Ivosidenib + mFOLFIRINOX in Patients With Resectable Pancreatic Adenocarcinoma

Inclusion Criteria

Exclusion Criteria

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