Utility of ctDNA in Early Switch of First-line mFOLFIRINOX in Metastatic Pancreatic Ductal Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami
About this trial
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 criteria
Qualifiers
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.
Treatment-naïve patients diagnosed with metastatic pancreatic adenocarcinoma.
Must have a detectable circulating tumor deoxyribonucleic acid (DNA) at cycle 1 day 1.
Patients must have a detectable circulating tumor deoxyribonucleic acid (ctDNA) quantity on Northstar Response assay at baseline.
Disqualifiers
Patients with pure neuroendocrine neoplasms of the pancreas.
Brain metastases.
Uncontrolled ascites.
Increase of ECOG to > 1 between screening and enrollment.
Trial design
Treatments tested in this trial
- 5-Fluorouracil
- Oxaliplatin
- Leucovorin
- Irinotecan
- Gemcitabine
- Nab Paclitaxel
- Circulating Tumor Deoxyribonucleic acid (ctDNA) Assay
Treatment groups
50 Participants
are divided into 3 treatment groupsSponsors and collaborators
University of Miami
Lead sponsor
National Cancer Institute (NCI)
Collaborator
BillionToOne Inc.
Collaborator
Source ClinicalTrials.gov