Study Title: PRIMUS 001
Study Description: 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
Study Design: An integrated randomised, unblinded and open-label phase II interventional trial with pre-clinical and translational work including in-depth molecular profiling and biomarker discovery/development. Patients to this trial will be randomised 1:1.
Primary Endpoint: To provide a phase II assessment of efficacy of FOLFOX-A when compared to AG in both the biomarker-positive group and in all (biomarker-unselected) patients, using PFS as the primary endpoint.
Trial Status: Open
Chief Investigator: Dr Janet Graham
Sponsor: NHS Greater Glasgow and Clyde
Date Opened: 28th November 2017
Planned Closure Date: 30th September 2021
Target Recruitment: 500
Open to New Sites: Yes
Contact Details:
Clinical Trials Unit, Glasgow (CTUG)
Project Manager: Sarah Bradley: [email protected]
Senior Clinical Trial Co-ordinator: Laura Divers: [email protected]
CRUK CTU, Glasgow
Pharmacovigilance Documentation
These are the current Summary of Product Characteristics (SmPCs) to be referred to for the clinical management of trial patients:
Clinical Management Reference Documents RSI Front Sheet
For queries concerning Pharmacovigilance or the documents acting as the Reference Safety Information please contact:
The Pharmacovigilance Team email: [email protected]
Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) being used for the study (if applicable): 4.03
Click here to download the CTCAE
