RecruitingPhase 1interventionalRules rewrite

Phase 1: testing modified FOLFIRINOX for Pancreatic Ductal Adenocarcinoma (PDAC)

The purpose of this research is to observe the effects of using a new combination of drugs to inhibit tumor growth.

Official registry: https://clinicaltrials.gov/study/NCT07829185 · University of Oklahoma · enrollment listed as 30

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are modified FOLFIRINOX, or Pentamidine 300 MG Injection. The registry lists allocation as randomized. The purpose of this research is to observe the effects of using a new combination of drugs to inhibit tumor growth.

They plan to enroll about 30 people at Oklahoma City. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Modified FOLFIRINOX and Pentamidine as First-line Treatment in Advanced and Metastatic Pancreatic Ductal Adenocarcinoma

Interventions: modified FOLFIRINOX, Pentamidine 300 MG Injection

Primary outcome (registry wording): Number and proportion of patients with Grade 3 and higher adverse events deemed related to pentamidine during trial treatment, using CTCAE v.6.0.

Who it is for (from inclusion criteria)

Ages 18 Years to any
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

Who the registry excludes

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
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

Public study contact (from the registry)

Marisha Williams

572-244-0111

SCC-IIT-Office@ouhsc.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

University of Oklahoma Health Campus — Oklahoma City, Oklahoma (recruiting)

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FAQ about this NCT record

Is NCT07829185 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07829185?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07829185?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary