Pancreatic Ductal Adenocarcinoma (PDAC)Phase 1FALCONNCT07829185
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
A Phase 1 study testing modified FOLFIRINOX and Pentamidine 300 MG Injection in people with Pancreatic Ductal Adenocarcinoma (PDAC), run by University of Oklahoma at 1 site in United States.
Trial summary
The purpose of this research is to observe the effects of using a new combination of drugs to inhibit tumor growth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma (PDAC)
- What is being tested?
- modified FOLFIRINOX and Pentamidine 300 MG Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2026to Dec 2030
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent signed and dated by the patient
- At least 18 years-of-age at the time of signature of the informed consent form (ICF)
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- Patients with a confirmed diagnosis of locally advanced, unresectable and/or metastatic pancreatic cancer
- Patients must have at least one measurable disease per RECIST v1.1,
- Patients must have at least 1 tumor lesion amenable to biopsy and must be willing to undergo a biopsy prior to first treatment and after receiving 8th cycle of therapy.
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- Adequate bone marrow function defined as ANC> 1000/μL and platelets>75,000/μL
- Adequate liver function defined as total bilirubin<1.5g/L
- Adequate renal function defined as creatinine <1.5ULN or creatinine clearance greater than 30 ml/m2.
- AST and ALT <2.5x ULN or AST and ALT<5xULN if liver function abnormalities are due to liver metastases
- Male or female patients. Male patients with female partners of childbearing potential and female patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for 30 days following the last dose. Male patients must also refrain from donating sperm during their participation in the study.
- Life expectancy ≥ 3 months according to the Investigator's judgment.
Who cannot join
- Any systemic anti-cancer chemotherapy, small molecule, biologic, or from a previous treatment regimen or clinical study in a metastatic setting before the first dose of study drug.
- Active bacterial infection
- Women who are pregnant, nursing, or who plan to become pregnant while in the study and for at least 6 months after the last administration of study treatment
- Men who plan to father a child while in the study and for at least 6 months after the last administration of study treatment
- Any of the following cardiac criteria currently or within the last 6 months:
- Mean resting corrected QT interval (QTc) >480 msec
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- Any clinically important abnormalities (as assessed by the Investigator) in rhythm, conduction, or morphology of resting electrocardiograms (ECGs), e.g., complete left bundle branch block, third degree heart block
- Congestive heart failure (New York Heart Association ≥ Grade 2
- Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-of-age, or any concomitant medication known to prolong the QT interval
- Incidences of chronic hypokalemia that cannot be corrected.
- As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, uncontrolled diabetes mellitus, active bleeding diatheses, or active infection requiring treatment including hepatitis B, hepatitis C, and human immunodeficiency virus. Screening for chronic conditions is not required.
- Presence of other active invasive cancers other than the one treated in this study within 2 years prior to screening, except appropriately treated basal cell carcinoma of the skin, or in situ carcinoma of uterine cervix, or other local tumors considered cured by local treatment
- Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.
- Prisoners
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Oklahoma Health Campus
Oklahoma City, Oklahoma, 73104
Susanna Ulahannan, MD, 572-244-0111, Susanna-Ulahannan@ou.edu
About this study
Official title: Modified FOLFIRINOX and Pentamidine as First-line Treatment in Advanced and Metastatic Pancreatic Ductal Adenocarcinoma
The purpose of this research is to observe the effects of using a new combination of drugs to inhibit tumor growth.
Read the detailed description
The patients will undergo testing, exams, and procedures per the Protocol. On study, patients will be randomized into one of the two arms. In Arm A (up to 15 patients) will be treated with modified FOLFIRINOX every two weeks, delivered as follows:
- Oxaliplatin 85mg/m2 IV over 2 hours on Day 1, followed by,
- Irinotecan 150mg/m2 IV over 90 minutes on Day 1, followed by
- Leucovorin 400mg/m2 IV over 2 hours on Day 1, followed by
- 5FU 2400mg/m2 IV over 46-48 hours on Days 1-3
In arm B patients (up to 15), the same modified FOLFIRINOX regimen will be used, as above, plus 300 mg pentamidine will be administered IV over a one-hour infusion on Day 1 of each cycle.
In both arms, patients will be treated over eight two-week cycles, and the entire treatment is expected to last approximately 4 months.
After eight cycles, patients will undergo another EUS core biopsy. At the same time as the biopsy, an additional blood draw (for translational endpoints) will be done.
After the biopsy, patients will continue treatment per physician's discretion for an additional 2 months (or 4 cycles) for a total of 12 cycles (or 6 months of treatment) until disease progression or appearance of unacceptable toxicity.
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Being tested
- modified FOLFIRINOX, Pentamidine 300 MG Injection
- Keywords
- modified FOLFIRINOX, Pentamidine, Advanced, Metastatic
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified FOLFIRINOXDrug
In Arm A (up to 15 patients) will be treated with modified FOLFIRINOX every two weeks, delivered as follows:
- Oxaliplatin 85mg/m2 IV over 2 hours on Day 1, followed by,
- Irinotecan 150mg/m2 IV over 90 minutes on Day 1, followed by
- Leucovorin 400mg/m2 IV over 2 hours on Day 1, followed by
- 5FU 2400mg/m2 IV over 46-48 hours on Days 1-3
Pentamidine 300 MG InjectionDrug
In arm B patients (up to 15), the same modified FOLFIRINOX regimen will be used, as above, plus 300 mg pentamidine will be administered IV over a one-hour infusion on Day 1 of each cycle.
| Study group | Role | What they receive |
|---|---|---|
| modified FOLFIRINOX | Active comparator | In Arm A (up to 15 patients) will be treated with modified FOLFIRINOX every two weeks, delivered as follows:
* Oxaliplatin 85mg/m2 IV over 2 hours on Day 1, followed by,
* Irinotecan 150mg/m2 IV over 90 minutes on Day 1, followed by
* Leucovorin 400mg/m2 IV over 2 hours on Day 1, followed by
* 5FU 2400mg/m2 IV over 46-48 hours on Days 1-3
Patients will be treated over eight two-week cycles, and the entire treatment is expected to last approximately 4 months. Receives: Drug: modified FOLFIRINOX |
| modified FOLFIRINOX + Pentamidine | Experimental | In arm B patients (up to 15), the same modified FOLFIRINOX regimen will be used, as above, plus 300 mg pentamidine will be administered IV over a one-hour infusion on Day 1 of each cycle.
Patients will be treated over eight two-week cycles, and the entire treatment is expected to last approximately 4 months. Receives: Drug: modified FOLFIRINOX; Drug: Pentamidine 300 MG Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and proportion of patients with Grade 3 and higher adverse events deemed related to pentamidine during trial treatment, using CTCAE v.6.0.
To evaluate the safety in patients with metastatic or nonresectable locally advanced pancreatic cancer treated with modified FOLFIRINOX (arm A) versus modified FOLFIRINOX plus Pentamidine (arm B)
Measured: 3 years
Secondary outcomes (5)
Evaluation of the objective response rate in modified FOLFIRINOX (arm A) versus modified FOLFIRINOX plus Pentamidine (arm B)
Proportion of patients with Objective response rate and partial response as measured by RECIST version 1.1 to be evaluated by imaging study and radiology review.
Measured: 3 years
Evaluation of the rate of progression-free survival in both arms
Proportion of patients with a response rate measurement of Progression-free survival determined by the number of days from the start of study treatment to date of imaging-confirmed tumor progression, death or last time of follow up
Measured: 3 years
Evaluation of the duration of response in both arms
Proportion of patients with Duration of response determined as the number of days from the onset of the first response to disease progression or death
Measured: 3 years
Evaluation of genetic mutations that predict patient response to modified FOLFIRINOX plus Pentamidine
Proportion of patients with expression levels of MUC1, SAT1, and other metabolic genes by performing transcriptomic analysis of biopsies.
Measured: 3 years
Evaluation of potential utility of N1-acetylspermidine and nucleotide pools as a biomarker of efficacy of the combination therapy.
Proportion of patients with circulating N'acetylspermidine1levels, other circulating polyamines levels, tumor tissue uptake of pentamidine by quantitating N1-acetylspermidine levels by liquid chromatography-coupled tandem mass spectrometry, and quantitate nucleotide pools in biopsy tissues by liquid chromatography-coupled tandem mass spectrometry
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start6 Oct 2026
- Primary completionDec 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal Adenocarcinoma (PDAC)Studies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susanna Ulahannan, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829185
- Sponsor's protocol ID
- OU-SCC-FALCON
- Acronym
- FALCON
- Status last verified
- Nov 2026
- First submitted
- 14 Sep 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified FOLFIRINOX and Pentamidine as First-line Treatment in Advanced and Metastatic Pancreatic Ductal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT07829185
- Acronym / sponsor ID
- FALCON / OU-SCC-FALCON
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Keywords
- modified FOLFIRINOX, Pentamidine, Advanced, Metastatic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 6 Oct 2026 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 18 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to observe the effects of using a new combination of drugs to inhibit tumor growth.
Detailed description
The patients will undergo testing, exams, and procedures per the Protocol. On study, patients will be randomized into one of the two arms. In Arm A (up to 15 patients) will be treated with modified FOLFIRINOX every two weeks, delivered as follows:
- Oxaliplatin 85mg/m2 IV over 2 hours on Day 1, followed by,
- Irinotecan 150mg/m2 IV over 90 minutes on Day 1, followed by
- Leucovorin 400mg/m2 IV over 2 hours on Day 1, followed by
- 5FU 2400mg/m2 IV over 46-48 hours on Days 1-3
In arm B patients (up to 15), the same modified FOLFIRINOX regimen will be used, as above, plus 300 mg pentamidine will be administered IV over a one-hour infusion on Day 1 of each cycle.
In both arms, patients will be treated over eight two-week cycles, and the entire treatment is expected to last approximately 4 months.
After eight cycles, patients will undergo another EUS core biopsy. At the same time as the biopsy, an additional blood draw (for translational endpoints) will be done.
After the biopsy, patients will continue treatment per physician's discretion for an additional 2 months (or 4 cycles) for a total of 12 cycles (or 6 months of treatment) until disease progression or appearance of unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| modified FOLFIRINOX | Active comparator | Drug: modified FOLFIRINOXIn Arm A (up to 15 patients) will be treated with modified FOLFIRINOX every two weeks, delivered as follows: * Oxaliplatin 85mg/m2 IV over 2 hours on Day 1, followed by, * Irinotecan 150mg/m2 IV over 90 minutes on Day 1, followed by * Leucovorin 400mg/m2 IV over 2 hours on Day 1, followed by * 5FU 2400mg/m2 IV over 46-48 hours on Days 1-3 Patients will be treated over eight two-week cycles, and the entire treatment is expected to last approximately 4 months. |
| modified FOLFIRINOX + Pentamidine | Experimental | Drug: modified FOLFIRINOX, Drug: Pentamidine 300 MG InjectionIn arm B patients (up to 15), the same modified FOLFIRINOX regimen will be used, as above, plus 300 mg pentamidine will be administered IV over a one-hour infusion on Day 1 of each cycle. Patients will be treated over eight two-week cycles, and the entire treatment is expected to last approximately 4 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Written informed consent signed and dated by the patient
- At least 18 years-of-age at the time of signature of the informed consent form (ICF)
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- Patients with a confirmed diagnosis of locally advanced, unresectable and/or metastatic pancreatic cancer
- Patients must have at least one measurable disease per RECIST v1.1,
Key exclusion criteria (14 listed)
- Any systemic anti-cancer chemotherapy, small molecule, biologic, or from a previous treatment regimen or clinical study in a metastatic setting before the first dose of study drug.
- Active bacterial infection
- Women who are pregnant, nursing, or who plan to become pregnant while in the study and for at least 6 months after the last administration of study treatment
- Men who plan to father a child while in the study and for at least 6 months after the last administration of study treatment
- Any of the following cardiac criteria currently or within the last 6 months:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| modified FOLFIRINOXIn Arm A (up to 15 patients) will be treated with modified FOLFIRINOX every two weeks, delivered as follows: * Oxaliplatin 85mg/m2 IV over 2 hours on Day 1, followed by, * Irinotecan 150mg/m2 IV over 90 minutes on Day 1, followed by * Leucovorin 400mg/m2 IV over 2 hours on Day 1, followed by * 5FU 2400mg/m2 IV over 46-48 hours on Days 1-3 | Drug | modified FOLFIRINOX, modified FOLFIRINOX + Pentamidine |
| Pentamidine 300 MG InjectionIn arm B patients (up to 15), the same modified FOLFIRINOX regimen will be used, as above, plus 300 mg pentamidine will be administered IV over a one-hour infusion on Day 1 of each cycle. | Drug | modified FOLFIRINOX + Pentamidine |
Primary outcome
Number and proportion of patients with Grade 3 and higher adverse events deemed related to pentamidine during trial treatment, using CTCAE v.6.0.
Time frame: 3 years
To evaluate the safety in patients with metastatic or nonresectable locally advanced pancreatic cancer treated with modified FOLFIRINOX (arm A) versus modified FOLFIRINOX plus Pentamidine (arm B)
5 secondary outcomes
Evaluation of the objective response rate in modified FOLFIRINOX (arm A) versus modified FOLFIRINOX plus Pentamidine (arm B)
Time frame: 3 years
Evaluation of the rate of progression-free survival in both arms
Time frame: 3 years
Evaluation of the duration of response in both arms
Time frame: 3 years
Evaluation of genetic mutations that predict patient response to modified FOLFIRINOX plus Pentamidine
Time frame: 3 years
Evaluation of potential utility of N1-acetylspermidine and nucleotide pools as a biomarker of efficacy of the combination therapy.
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susanna Ulahannan, MD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing modified FOLFIRINOX and Pentamidine 300 MG Injection in people with Pancreatic Ductal Adenocarcinoma (PDAC), run by University of Oklahoma 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 12 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 6 Nov 2026. 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?
Contact Marisha Williams (572-244-0111, SCC-IIT-Office@ouhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and proportion of patients with Grade 3 and higher adverse events deemed related to pentamidine during trial treatment, using CTCAE v.6.0. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2026.