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Pancreatic Cancer MetastaticPhase 2PASS-01NCT04469556

Pancreatic Adenocarcinoma Signature Stratification for Treatment

A Phase 2 study testing Folfirinox and Gemcitabine/nab-paclitaxel in people with Pancreatic Cancer Metastatic and Pancreatic Ductal Adenocarcinoma, run by University Health Network, Toronto at 6 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Folfirinox and Gemcitabine/nab-paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
6 sitesin 2 countries
Study dates
14 Oct 2020to 5 Mar 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.
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  • 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. -

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

United States4 sites

  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21231

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Northwell Health

    New Hyde Park, New York, 11042

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

Canada2 sites

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2N9

  • BC Cancer Agency Vancouver

    Vancouver, British Columbia, V5Z 1L8

Other trials in Canada

About this study

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.

Read the detailed description

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.

Being tested
Folfirinox, Gemcitabine/nab-paclitaxel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FolfirinoxDrug

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

    Chemotherapy

  • Gemcitabine/nab-paclitaxelDrug

    Chemotherapy

Study groups in NCT04469556
Study groupRoleWhat they receive
Modified FolfirinoxActive comparatorModified 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.
Receives: Drug: Folfirinox
Gemcitabine/nab-PaclitaxelActive comparatorGemcitabine/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.
Receives: Drug: Gemcitabine/nab-paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival(PFS) in mFFX and GA arms pancreatic ductal adenocarcinoma (PDAC) in a randomized phase II trial.

    Time from the date of randomization to progression based on the radiology assessment of response using RECIST v1.1, or death, whichever is earlier

    Measured: 2-4 years

Secondary outcomes (8)

  1. ORR by RECIST 1.1 and duration of response in patients receiving mFFX or GA

    percentage of patient's measurable disease who have achieved either complete response (CR) or partial response (PR)

    Measured: 2-4 years

  2. Overall survival (OS) associated with mFFX or GA profiles, signatures and pharmacotyping

    Measured: 2-4 years

  3. GATA6 as a biomarker of response to mFFX or GA

    Measured: 2-4 years

  4. • Concordance between organoid transcriptomic profiles (RNAseq) and patient transcriptomic profiles (descriptive statistics)

    Measured: 2-4 years

  5. • Concordance between chemotherapy sensitivity signature predictions and response to first line treatment (descriptive statistics).

    Measured: 2-4 years

  6. • Correlation of individual tumour cytokeratins (eg. CK5 and CK17 expression) with chemotherapy response and resistance

    Measured: 2-4 years

  7. Cell free circulating tumor (ct) DNA analysis (including KRAS mutational status)

    Measured: 2-4 years

  8. Cluster Tendency analysis using artificial neural networks and radiomic methods combined

    Measured: 2-4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2020
  2. Study start14 Oct 2020
  3. Primary completion5 Mar 2025
  4. Study completion5 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04469556
Sponsor's protocol ID
PASS-01
Other IDs
CAPCR ID: 20-5105
Acronym
PASS-01
Status last verified
Feb 2026
First submitted
26 Jun 2020
Last updated
20 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Folfirinox and Gemcitabine/nab-paclitaxel in people with Pancreatic Cancer Metastatic and Pancreatic Ductal Adenocarcinoma, run by University Health Network, Toronto at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival(PFS) in mFFX and GA arms pancreatic ductal adenocarcinoma (PDAC) in a randomized phase II trial. (time frame: 2-4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04469556.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.

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