Pancreatic Adenocarcinoma Signature Stratification for Treatment

Completed · Phase 2

Conditions studied: Pancreatic Cancer Metastatic, Pancreatic Ductal Adenocarcinoma, Advanced Pancreatic Cancer

In brief

This is a randomized multicentre phase II trial with a large translational component. The trial will evaluate the two standard chemotherapy regimens: modified folfirinox (mFFX) and gemcitabine/nab-paclitaxel (GA), in patients with untreated metastatic pancreatic ductal adenocarcinoma. Integrated into this phase II trial are a number of laboratory components including molecular profiling, patient derived organoid establishment, and drug testing sensitivity and other biomarkers.

Key facts

Study ID

NCT04469556

Run by

University Health Network, Toronto

People needed

150

Starts

2020-10-14

Expected to finish

2025-03-05

Last updated by the study team

2026-02-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have a histological or radiological diagnosis of untreated metastatic PDAC at screening with histology subsequently confirmed prior to randomization.
• Eligible histologic variants include adenocarcinoma or variants to include mucinous adenocarcinoma or adenosquamous carcinoma.
• Patients with a history of prior or concurrent second primary malignancy whose natural history or treatment does not have the potential to interfere with the safety or primary endpoint efficacy assessment of the pancreas cancer should generally be eligible for enrollment in clinical trials.
• Age ≥18 years.
• Patient must have a tumor lesion that is amenable to a core needle biopsy.
• Patients must be suitable for treatment with either mFFX and GA without contraindications to either regimen.
• Eastern Cooperative Group (ECOG) performance status 0-1. (Karnofsky ≥70%).
• Life expectancy of greater than 90 days, as judged by the investigator
• Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test and must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
• Within 14 days of the proposed randomization date, patients must have normal organ and marrow function

You may not qualify if…

• Patients who have received prior systemic treatment for PDAC, including treatment in the neoadjuvant or adjuvant setting. Prior surgery or palliative radiation is permitted.
• Patients with histology other than pancreatic ductal adenocarcinoma. Those with adenosquamous are allowed. Acinar tumors and colloid are excluded.
• Patients with one or more contraindications to tumor biopsy according to local institution's standard biopsy procedures.
• Patients with known brain metastases are excluded from participation in this clinical study.
• Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, inability to stop anticoagulation medication for a biopsy, or psychiatric illness/social situations that would limit compliance with study requirements.
• Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
• Patients with a known germline mutation in BRCA, PALB2 or other homologous Recombination Repair Deficiency (HRD) genes.
• Patients who are pregnant or breastfeeding.
• Use (including 'recreational use') of any illicit drugs or other substance abuse (including alcohol) that could potentially interfere with adherence to study procedures or requirements. *Use of any illicit drugs or other substance abuse (including alcohol) are not screened in Canada using Toxicity testing. -

Where it is running

• Johns Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Northwell Health — New Hyde Park, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• BC Cancer Agency Vancouver — Vancouver, British Columbia, Canada
• Princess Margaret Cancer Centre — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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