Pancreatic Adenocarcinoma Signature Stratification for Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-14

Study Completion Date

2026-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Gemcitabine+Nab-paclitaxel and FOLFIRINOX and Molecular Profiling for Patients With Advanced Pancreatic Cancer

NCT01488552

Stage IV Pancreatic Cancer

COMPLETED PHASE1/PHASE2

A Study of Narmafotinib Given in Combination With Modified FOLFIRINOX in Patients With Metastatic Pancreatic Cancer

NCT07026279

Pancreatic Cancer Metastatic

RECRUITING PHASE1/PHASE2

Efficacy Evaluation of Sequential Treatment With AG and Modified Folfirinox in Metastatic Pancreatic Adenocarcinoma

NCT03633734

Pancreatic Adenocarcinoma Metastatic Chemotherapy Effect

UNKNOWN PHASE1/PHASE2

Trial Comparing Adjuvant Chemotherapy With Gemcitabine Versus mFolfirinox to Treat Resected Pancreatic Adenocarcinoma

NCT01526135

Pancreatic Adenocarcinoma (Ductal Adenocarcinoma)

COMPLETED PHASE3

Trial to Investigate Intensified Neoadjuvant Chemotherapy in Locally Advanced Pancreatic Cancer

NCT02125136

Ductal Adenocarcinoma of the Pancreas

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The two chemotherapy regimens GA and mFFX remain standard treatment options without biomarkers to predict response. PASS-01 will for the first time explore progression free survival differences in the two standard backbone regimens used in the advanced setting. Biomarker driven strategies in pancreatic ductal adenocarcinoma (PDAC) are lacking, perhaps accounting for a large number of failed phase II studies. This study will evaluate two standard of care chemotherapy regimens, but will also explore high content molecular profiling, chemotherapy sensitivity signatures, GATA6 and other putative biomarkers as predictors of response to chemotherapy. In addition, the use of patient derived organoid models for personalized medicine in PDAC will continue to develop within this study.

Approximately 150 patients diagnosed with untreated metastatic pancreatic cancer will be randomized to either arm.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pancreatic Cancer Metastatic Pancreatic Ductal Adenocarcinoma Advanced Pancreatic Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Approximately 150 patients will be randomized in a 1:1 ratio to receive one of the two standard of care regimens in patients with confirmed metastatic PDAC

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Modified Folfirinox

Modified FOLFIRINOX (Folinic acid/Leucovorin, 5-Fluouracil, Irinotecan, Oxaliplatin) administered intravenously.

Given that both regimens are standard of care, study treatment will be administered as per standard of care at each institution including a maintenance therapy approach which is encouraged in both arms. Dose modifications, anti-emetics, supportive medications, and use of growth factors should follow institutional guidelines.

Group Type ACTIVE_COMPARATOR

Folfirinox

Intervention Type DRUG

Chemotherapy

Gemcitabine/nab-Paclitaxel

Gemcitabine/nab-Paclitaxel administered intravenously.

Given that both regimens are standard of care, study treatment will be administered as per standard of care at each institution including a maintenance therapy approach which is encouraged in both arms. Dose modifications, anti-emetics, supportive medications, and use of growth factors should follow institutional guidelines.

Group Type ACTIVE_COMPARATOR

Gemcitabine/nab-paclitaxel

Intervention Type DRUG

Chemotherapy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Folfirinox

Chemotherapy

Intervention Type DRUG

Gemcitabine/nab-paclitaxel

Chemotherapy

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Folinic Acid/Leucovorin, 5-Fluouracil, Irinotecan, Oxaliplatin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patients must have a histological or radiological diagnosis of untreated metastatic PDAC at screening with histology subsequently confirmed prior to randomization.
2. Eligible histologic variants include adenocarcinoma or variants to include mucinous adenocarcinoma or adenosquamous carcinoma.
3. 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.
4. Age ≥18 years.
5. Patient must have a tumor lesion that is amenable to a core needle biopsy.
6. Patients must be suitable for treatment with either mFFX and GA without contraindications to either regimen.
7. Eastern Cooperative Group (ECOG) performance status 0-1. (Karnofsky ≥70%).
8. Life expectancy of greater than 90 days, as judged by the investigator
9. 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.
10. Within 14 days of the proposed randomization date, patients must have normal organ and marrow function

Exclusion Criteria

1. Patients who have received prior systemic treatment for PDAC, including treatment in the neoadjuvant or adjuvant setting. Prior surgery or palliative radiation is permitted.
2. Patients with histology other than pancreatic ductal adenocarcinoma. Those with adenosquamous are allowed. Acinar tumors and colloid are excluded.
3. Patients with one or more contraindications to tumor biopsy according to local institution's standard biopsy procedures.
4. Patients with known brain metastases are excluded from participation in this clinical study.
5. 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.
6. 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.
7. Patients with a known germline mutation in BRCA, PALB2 or other homologous Recombination Repair Deficiency (HRD) genes.
8. Patients who are pregnant or breastfeeding.
9. 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. -

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No