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
Click here to download the Initiation Slides Initiation Slides
These are the current Summary of Product Characteristics (SmPCs) to be referred to for the clinical management of trial patients:
- Fluorouracil 24 APR 2019
- Folinic Acid 27 AUG 2018
- Gemcitabine 12 JUL 2019
- Oxaliplatin 04 APR 2019
- Abraxane 03 April 2019
- Capecitabine 25 Jul 2019
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