PurIST Classification-Guided Adaptive Neoadjuvant Chemotherapy by RNA Expression Profiling of EUS Aspiration Samples

NCT04683315 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: PRO00039451
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

Brief Summary

This is an open-label, phase II study in patients with resectable and borderline resectable pancreatic cancer.

Conditions

Pancreatic Cancer

Keywords

molecular profiling; neoadjuvant; pancreatic adenocarcinoma; pancreas cancer; CA19-9; MCW

Outcome Measures

Primary Outcomes (1)

• Subjects who receive PurIST classification-directed therapy.

  The number of subjects who receive PurIST classification-directed therapy and have a treatment response following 12 weeks of therapy.

  12 weeks

Secondary Outcomes (4)

• Treatment response for subjects with basal subtype tumors.

  12 weeks

• Treatment response for subjects with classical subtype tumors.

  12 weeks

• Subjects with basal subtype tumors who complete all intended neoadjuvant therapy and surgical therapy.

  One year

• Subjects with classical subtype tumors who complete all intended neoadjuvant therapy and surgical therapy.

  One year

Study Arms (2)

Subtype diagnosis and classification: Basal

EXPERIMENTAL

Patients will be classified by (molecular) subtype (using the PurIST classifier) into two groups: basal and classical pancreatic cancer. Upon diagnosis, patients categorized as basal will receive two months of the Gemcitabine/Nab-paclitaxel Treatment Regimen.

Drug: Gemcitabine/Nab-paclitaxel Treatment Regimen

Subtype diagnosis and classification: Classical

EXPERIMENTAL

Patients will be classified by (molecular) subtype (using the PurIST classifier) into two groups: basal and classical pancreatic cancer. Patients in the classical group will receive two months of the mFOLFIRINOX Treatment Regimen.

Drug: mFOLFIRINOX Treatment Regimen

Interventions

mFOLFIRINOX Treatment Regimen DRUG

This therapy will be 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX).

Also known as: Fluorouracil, Folinic acid, Camptosar, Eloxatin

Subtype diagnosis and classification: Classical

Gemcitabine/Nab-paclitaxel Treatment Regimen DRUG

This regimen will be nab-paclitaxel and gemcitabine.

Also known as: Gemzar, Abraxane

Subtype diagnosis and classification: Basal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have suspicion of pancreas adenocarcinoma and plan for endoscopic biopsy.
• Plan for endoscopic biopsy or agreeable to an additional EUS/FNA for research purposes, otherwise plan to obtain archival tissue for PurlST testing.
• Be 18 years of age or older.
• Be able to understand and provide written informed consent or have a legally authorized representative (LAR).
• Have documentation of histologically confirmed adenocarcinoma.
• Have an Eastern Cooperative Group (ECOG) performance status \< 2.
• Have clinical stage consistent with resectable, borderline resectable adenocarcinoma of the pancreas, based on CT or MRI findings.
• Have adequate organ and bone marrow function, as defined by
• total leukocytes \>3 x103/μL.
• absolute neutrophil count (ANC) \>1.5x 103/μL.
• hemoglobin \>9 g/dL.
• platelets \>100 x 10e3/μL.
• creatinine clearance \>60 mL/min or creatinine \<1.5 mg/dL.
• bilirubin: may be enrolled with an elevated total bilirubin providing current elevated total bilirubin is shown to be in decline following a stent placement and is judged low enough to safely to begin their assigned chemotherapy regimen by the treating medical oncologist
• aspartate transaminases (AST/SGOT) and alanine transaminases (ALT/SGPT) \<3 x upper limit of normal (ULN). At two weeks from biliary decompression, if the subject's serum AST/ALT remains greater 3x ULN, but has demonstrated a progressive decline, the subject may be enrolled into the trial and appropriate modification and dose adjustments will be made to the assigned regimen. Eligibility of subjects whose AST/ALT remain elevated 3x ULN, without demonstrating a downward trend, will be determined at the discretion of the trial PIs.

You may not qualify if:

• Has received chemotherapy and/or radiation within three years prior to study enrollment.
• Has any previous history of another malignancy (other than cured basal or squamous cell carcinoma of the skin or cured in situ carcinoma of the cervix or localized prostate cancer with normal prostate specific antigen) within three years of study enrollment.
• Uncontrolled comorbidities including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina, unstable cardiac arrhythmias, psychiatric illness, excessive obesity (BMI \>55) or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent.
• Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
• Pregnant or breastfeeding patients or any patient with childbearing potential not using contraception four weeks prior to treatment.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (2)

HonorHealth Medical Group

Scottsdale, Arizona, 85258-4566, United States

RECRUITING

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Related Publications (1)

• Li Y, Merker JD, Kshatriya R, Trembath DG, Morrison AB, Kuhlers PC, Rashid NU, Yeh JJ, Gulley ML. Purity Independent Subtyping of Tumors (PurIST) Pancreatic Cancer Classifier: Analytic Validation of a 16-RNA Expression Signature Distinguishing Basal and Classical Subtypes. J Mol Diagn. 2024 Nov;26(11):962-970. doi: 10.1016/j.jmoldx.2024.07.002. Epub 2024 Aug 22.

  PMID: 39181325 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Fluorouracil; Leucovorin; Irinotecan; Oxaliplatin; Gemcitabine; Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Camptothecin; Alkaloids; Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Kathleen K Christians, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Medical College of Wisconsin Cancer Center Clinical Trials Office

CONTACT

866-680-0505; cccto@mcw.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 19, 2020
• First Posted: December 24, 2020
• Study Start: April 1, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)