Study Title: PRIMUS 002

Study Description: An umbrella phase II study examining two neo-adjuvant regimens (FOLFOX-A and AG) in resectable and borderline resectable Pancreatic Ductal AdenoCarcinoma (PDAC), focusing on biomarker and liquid biopsy development.

Study Design: An integrated, interventional, open label, phase II trial of 2 neo-adjuvant regimens (FOLFOX-A and AG) assessing their efficacy and toxicity with pre-clinical and translational work. The study is powered on testing a proposed biomarker for responsiveness in patients treated with FOLFOX-A; patients being treated with AG are recruited concurrently.

Primary Endpoint: The primary study end-point is progression post FOLFOX-A induction treatment as defined by RECIST 1.1 The association of this with a proposed biomarker of treatment responsiveness will be examined.

The primary translational objective of PRIMUS 002 is to assess efficacy of proposed biomarker(s) in predicting disease progression (treatment failure) rates in FOLFOX-A.

Trial Status: open

Chief Investigator: Dr Derek Grose

Sponsor: NHS Greater Glasgow and Clyde

Date Opened: 5th March 2019

Planned Closure Date: 31st August 2021

Target Recruitment: 242

Open to New Sites: No

Contact Details:

Clinical Trials Unit, Glasgow (CTUG)
Project Manager: Sarah Bradley: [email protected]
Clinical Trial Co-ordinator: Avril Trevethan: [email protected]
CRUK CTU, Glasgow

Click here to download the Initiation Slides Initiation Slides

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 (06 JUL 2020)

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