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Old antiparasitic drug joins chemo in pancreatic cancer fight

NCT ID NCT07829185

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Researchers at the University of Oklahoma are testing whether adding pentamidine, an antiparasitic drug, to standard modified FOLFIRINOX chemotherapy is safe and helps shrink tumors in people with advanced or metastatic pancreatic cancer. Up to 30 adults with confirmed locally advanced or metastatic pancreatic ductal adenocarcinoma will receive either the chemotherapy alone or the chemotherapy plus intravenous pentamidine every two weeks. The trial's main goal is to measure serious side effects tied to pentamidine, with tumor response tracked as a secondary measure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pentamidine added to modified FOLFIRINOX chemotherapy
What this could lead to
If it works, adding pentamidine could give doctors another way to slow tumor growth in advanced pancreatic cancer, a disease with few good options.
What could go wrong
This is a small phase 1 trial focused first on safety, so it may show the combination is too toxic or does not shrink tumors. Results in 30 people may not hold up in larger studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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: 1. Mean resting corrected QT interval (QTc) \>480 msec 2. 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 3. Congestive heart failure (New York Heart Association ≥ Grade 2 4. 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

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  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • University of Oklahoma Health Campus

    Oklahoma City, Oklahoma, 73104, United States

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