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Pancreatic Ductal AdenocarcinomaPhase 1NCT05209074

Ivosidenib + mFOLFIRINOX in Patients With Resectable Pancreatic Adenocarcinoma

A Phase 1 study testing Ivosidenib and mFOLFIRINOX in people with Pancreatic Ductal Adenocarcinoma and Resectable Pancreatic Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Ivosidenib and mFOLFIRINOX
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
8 Sep 2022to 31 Dec 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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 of the PI or investigators.
  • Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device) during the study, and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation.
  • Fertile men must practice effective contraceptive methods (i.e. surgical sterilization, or a condom used with a spermicide) during the study, unless documentation of infertility exists.
  • No evidence of clinically significant active infection and no seriousor chronicinfection requiring ongoing antibiotics during the study period.
  • Subjects must have the ability to understand and the willingness to sign a written informed consent document.
  • People of all races and ethnic groups are eligible for participation in this trial.

Who cannot join

  • 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.
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  • 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.
  • Subjects with a serious medical illness that would potentially increase subjects' risk for toxicity
  • Subjects with any active uncontrolled bleeding, and any participants with a bleeding diathesis (e.g., active peptic ulcer disease).
  • Subjects with a history of myocardial infarction that is <3 months prior to registration.
  • Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure or coronary artery disease, unstable angina pectoris, cardiac arrhythmiarequiring medications that interact with ivosidenib, symptomatic myocardial infarction or psychiatric illness/social situations that would limit compliance with study requirements.
  • Subjects who are known to be HIV-positive and on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with ivosidenib.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106

Other trials in United States

About this study

Official title: A Phase I, Single-Center, Open-Label, Dose De-escalation and Expansion Study Ivosidenib + mFOLFIRINOX in Patients With Resectable Pancreatic Adenocarcinoma

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.

Read the 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.

Being tested
Ivosidenib, mFOLFIRINOX

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IvosidenibDrug

    Ivosidenibflat dose (250mgor 500mg) daily on day 1 of a 14 day cycle.

  • mFOLFIRINOXDrug

    mFOLFIRINOX on days 1-3 of a 14-day cycle. Surgical resection after up to ninety (90) days of treatment.

Study groups in NCT05209074
Study groupRoleWhat they receive
Ivosidenib+mFOLFIRINOXExperimentalNot described
Receives: Drug: Ivosidenib; Drug: mFOLFIRINOX

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum-tolerated dose (MTD) or Recommended Phase 2 dose (RP2D)

    Evaluate by the Bayesian optimal interval (BOIN) strategy to identify the MTD.

    Measured: Up to 24 months from the start of treatment

Secondary outcomes (3)

  1. RECIST version 1.1 response rates.

    Number of participants with the progression-free occurrence.

    Measured: Up to 24 weeks from the start of treatment

  2. Major pathologic response rates

    Number of participants in whom historical treatment's response rate of 10%

    Measured: Up to 24 weeks from the start of treatment

  3. Biochemical response rates

    Number of participants with normalization of serum tumor markers during treatment and after surgery.

    Measured: Up to 24 weeks from the start of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2022
  2. Study start8 Sep 2022
  3. Primary completion15 Jul 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05209074
Sponsor's protocol ID
CASE7221
Status last verified
Sep 2025
First submitted
12 Jan 2022
Last updated
5 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Zarei M, Hajihassani O, Hue JJ, Graor HJ, Rothermel LD, Winter JM. Targeting wild-type IDH1 enhances chemosensitivity in pancreatic cancer. bioRxiv [Preprint]. 2023 Mar 29:2023.03.29.534596. doi: 10.1101/2023.03.29.534596.

    PubMed 37034685

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ivosidenib and mFOLFIRINOX in people with Pancreatic Ductal Adenocarcinoma and Resectable Pancreatic Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum-tolerated dose (MTD) or Recommended Phase 2 dose (RP2D) (time frame: Up to 24 months from the start of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05209074, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.

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