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Comparing two chemotherapy regimens for metastatic pancreatic cancer

PRIMUS 001: An Adaptive Phase II Study of FOLFOX-A (FOLFOX and Nab-paclitaxel) Versus AG (Nab-paclitaxel and Gemcitabine) in Patients With Metastatic Pancreatic Cancer, With Integrated Biomarker Evaluation

Phase 2 Interventional University of Glasgow · NCT04151277

This study is testing two different chemotherapy combinations to see which one helps people with metastatic pancreatic cancer live longer without their disease getting worse.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment500 (estimated)
Ages16 Years and up
SexAll
SponsorUniversity of Glasgow Academic / other
Drugs / interventionschemotherapy
Locations30 sites (Aberdeen and 29 other locations)
Trial IDNCT04151277 on ClinicalTrials.gov

What this trial studies

PRIMUS 001 is a multicentre, randomised, open label, phase II trial that compares the efficacy of two chemotherapy combinations, FOLFOX-A and AG, in patients with metastatic pancreatic cancer. Participants will be randomly assigned to receive one of the two treatments, and the study will focus on progression-free survival as the primary outcome measure. The trial also includes pre-clinical and translational work, such as molecular profiling and biomarker discovery, to enhance understanding of treatment responses. Treatment will continue until disease progression, intolerable toxicity, or patient/clinician decision.

Who should consider this trial

Good fit: Ideal candidates are patients aged 16 years or older with histologically-confirmed metastatic pancreatic ductal adenocarcinoma who have not received prior chemotherapy for metastatic disease.

Not a fit: Patients with ongoing toxicities from previous treatments or those with a life expectancy of less than 12 weeks may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective chemotherapy regimen for patients with metastatic pancreatic cancer.

How similar studies have performed: Other studies have explored chemotherapy regimens for pancreatic cancer, but the specific comparison of FOLFOX-A and AG in this context is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Patient has been enrolled in the Precision-Panc Master Protocol
2. Patient has provided signed information consent for the PRIMUS 001 study
3. Age ≥ 16 years
4. Histologically-confirmed pancreatic ductal adenocarcinoma and its varients
5. Measurable metastatic disease according to RECIST V1.1
6. Eastern Cooperative Oncology Group (ECOG) 0-1 with life expectation of no less than 12 weeks
7. Patients must have received no previous chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatment with a fluoropyrimidine and/or gemcitabine administered in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no ongoing toxicities are present
8. Adequate liver/bone marrow function as defined by:

   1. Neutrophils (ANC) ≥ 1.5 x 109/l
   2. Platelets ≥ 100 x 109/l
   3. Haemoglobin ≥ 9.0 g/dL
   4. White Blood Cells (WBC) ≥ 3 x 109/l
   5. Total bilirubin ≤ 1.5 x institutional ULN unless bilirubin rise is due to Gilbert's syndrome
   6. Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN ( \<5 ULN in the presence of liver metastases)
   7. Estimated creatinine clearance ≥ 60 mL/min (as calculated by Cockcroft and Gault or Wright formula or measured by EDTA clearance) 9. Negative serum or urine Human Chorionic Gonadotropin (HCG) test for females with child bearing potential. Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential 10. Woman of child bearing potential, and men with female partners of child bearing potential, must agree to use adequate contraceptive measures (see s section 8.1.8.1) for the duration of the study and for up to 6 months after the completion of study treatment. 11. Compliant, and can be followed up regularly

The following additional inclusion criteria is ONLY required if recommended by the independent Data Monitoring Committee after interim review of study data (sites will have been informed by the Cancer Research UK (CRUK) Clinical Trials Unit (CTU) if this is the case) 12. Patient must be biomarker positive as fed back after central Precision-Panc diagnostic testing

Exclusion Criteria:

1. Prior treatment with nab-paclitaxel or oxaliplatin
2. Prior chemotherapy for metastatic pancreatic cancer
3. Known hypersensitivity for any component of any study drug
4. Active infection including Herpes Zoster and chickenpox
5. Current neuropathy ≥ grade 2
6. Uncontrolled brain metastasis
7. Uncontrolled congestive heart failure (CHF), or history of myocardial ischemia (MI), unstable angina, stroke, or transient ischemia within previous 6 months
8. Uncontrolled serious contraindicated medical condition or illness
9. Known or suspected dihydropyrimidine dehydrogenase (DPD) deficiency
10. Pregnant or breastfeeding
11. History of physical or psychiatric disorder that would prevent informed consent and compliance with protocol
12. Administration of any investigational drug within 28 days or 5 half-lives, whichever is longer, of receiving the first dose of trial treatment
13. Any systemic anti-cancer therapy or major surgery within 28 days of randomisation
14. Any minor surgery or radiotherapy within 7 days of randomisation
15. Any psychological, familial, sociological or geographical consideration potentially hampering compliance with the trial protocol and follow up schedule
16. Any patients receiving treatment with brivudin, sorivudin and analogues
17. History of another malignancy in the last 5 years (other than treated squamous/basal cell skin cancer, treated early-stage cervical cancer or treated/biochemically-stable organ-confined prostate cancer)
18. Any patient with severe diarrhoea (defined as ≥grade 3 diarrhoea despite maximum supportive measures and exclusion of underlying infection)

Where this trial is running

Aberdeen and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Neoplasms Pancreatic
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.