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Utility of ctDNA in Early Switch of First-line mFOLFIRINOX in Metastatic Pancreatic Ductal Adenocarcinoma | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Utility of ctDNA in Early Switch of First-line mFOLFIRINOX in Metastatic Pancreatic Ductal Adenocarcinoma

A Phase 2 Study Assessing Utility of ctDNA in Early Switch of First-line mFOLFIRINOX in Metastatic Pancreatic Ductal Adenocarcinoma

NCT07096362•University of Miami

View on ClinicalTrials.gov

Summary

The purpose of this study is to understand whether a blood-based test called circulating tumor DNA (ctDNA) can detect whether participants are having a desired tumor shrinkage or an undesired lack of tumor shrinkage, and to study whether these levels of ctDNA can be used to make treatment decisions faster than the current standard approach, which is to wait 8 weeks after starting chemotherapy to obtain participant first imaging scans since starting chemotherapy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histologically confirmed, metastatic pancreatic adenocarcinoma. Patients with adenosquamous carcinoma and mixed adenocarcinoma/neuroendocrine carcinoma (MANEC) of the pancreas are eligible, but pure neuroendocrine neoplasms are excluded.
•2. Treatment-naïve patients diagnosed with metastatic pancreatic adenocarcinoma.
•3. Must have a detectable circulating tumor deoxyribonucleic acid (DNA) at cycle 1 day 1.
•4. Patients must have a detectable circulating tumor deoxyribonucleic acid (ctDNA) quantity on Northstar Response assay at baseline.
•5. At least one tumor measurable by Computed Tomography (CT) scan or Positron Emission Tomography-Computed Tomography (PET/CT) scan. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \>20 mm with conventional techniques or \>10 mm with spiral CT scan.
•6. Adult male and female participants (≥ 18 years of age).
•7. Male or non-pregnant and non-lactating female. Men and women with intact reproductive potential must agree to use contraception.
•8. Adequate biological parameters as demonstrated by the following blood counts at Screening (obtained ≤ 21 days prior to enrollment) and at Baseline-Day 0:
•* Absolute neutrophil count (ANC) ≥ 1.0 × 109 cells/L.
•* Platelet count ≥ 100,000 cells/mm3 (100 × 109 cells/L). Supportive platelet transfusions are acceptable.
+9 more criteria

Exclusion Criteria

•1. Patients with pure neuroendocrine neoplasms of the pancreas.
•2. Brain metastases.
•3. Uncontrolled ascites.
•4. Increase of ECOG to \> 1 between screening and enrollment.
•5. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
•6. History of untreated or uncontrolled HIV and/or Hepatitis B or C infection.
•7. Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality, including any of the following:
•* History of myocardial infarction, angina pectoris, symptomatic pericarditis, or coronary artery bypass graft within six months prior to study entry
•* Documented cardiomyopathy
•8. Grade 2 or greater sensory peripheral neuropathy.
+7 more criteria

Locations (1)

University of Miami

Miami, Florida, United States

Key Dates

Start Date

September 9, 2025

Primary Completion Date

September 30, 2030

Completion Date

September 30, 2030

Last Updated

September 23, 2025

Enrollment

ESTIMATED participants

Conditions

Metastatic Pancreatic Ductal AdenocarcinomaPancreatic Ductal Adenocarcinoma

Interventions

5-Fluorouracil

DRUG

Oxaliplatin

DRUG

Leucovorin

DRUG

Irinotecan

DRUG

Gemcitabine

DRUG

Nab Paclitaxel

DRUG

Circulating Tumor Deoxyribonucleic acid (ctDNA) Assay

DIAGNOSTIC_TEST

Contacts

Siudy Vasquez

CONTACT

(305) 243-2647 sxv507@med.miami.edu

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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 23, 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.

View ClinicalTrials.gov Terms and Conditions

Utility of ctDNA in Early Switch of First-line mFOLFIRINOX in Metastatic Pancreatic Ductal Adenocarcinoma

Inclusion Criteria

Exclusion Criteria

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