Spots Global Cancer Trial Database for PRIMUS 001: A Study Looking at Two Different Chemotherapy Regimens in Patients With Metastatic Pancreatic Cancer
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Trial Identification
Brief Title: PRIMUS 001: A Study Looking at Two Different Chemotherapy Regimens in Patients With Metastatic Pancreatic Cancer
Official Title: 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
Study ID: NCT04151277
Conditions
Study Description
Brief Summary: This study is comparing two combinations of chemotherapy treatments in patients with metastatic pancreatic cancer. Half the participants will receive FOLFOX-A and the other half will receive AG. Treatment will continue until progression or patient/clinican decision or intolerable toxicity.
Detailed Description: PRIMUS 001 is a multicentre, randomised, open label, two arm, phase II interventional trial with pre-clinical and translational work including in-depth molecular profiling and biomarker discovery/development. The primary objective is to look at the efficacy of FOLFOX-A compared to AG in all comers and in a biomarker positive group using progression free survival.
Keywords
Eligibility
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Aberdeen Royal Infirmary, Aberdeen, , United Kingdom
Northern Ireland Cancer Centre, Belfast, , United Kingdom
Queen Elizabeth Hospital, Birmingham, , United Kingdom
Royal Bournemouth Hospital, Bournemouth, , United Kingdom
Bristol Oncology Centre, Bristol, , United Kingdom
Addenbrooke's Hospital, Cambridge, , United Kingdom
Castle Hill Hospital, Cottingham, , United Kingdom
Ninewells Hospital, Dundee, , United Kingdom
Western General, Edinburgh, , United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Huddersfield Royal Infirmary, Huddersfield, , United Kingdom
Raigmore Hospital, Inverness, , United Kingdom
St James's University Hospital, Leeds, , United Kingdom
The Clatterbridge Cancer Centre, Liverpool, , United Kingdom
Guy's Hospital, London, , United Kingdom
Imperial College Healthcare Trust, London, , United Kingdom
Royal Free London Hospital, London, , United Kingdom
Royal Marsden Hospital, London, , United Kingdom
St Bart's Hospital, London, , United Kingdom
St George's Hospital, London, , United Kingdom
University College London Hospital, London, , United Kingdom
The Christie, Manchester, Manchester, , United Kingdom
Milton Keynes General Hospital, Milton Keynes, , United Kingdom
Freeman Hospital, Newcastle, , United Kingdom
Nottingham University Hospital, Nottingham, , United Kingdom
Churchill Hospital, Oxford, , United Kingdom
Poole Hospital, Poole, , United Kingdom
Weston Park, Sheffield, , United Kingdom
University of Southampton Hospital, Southampton, , United Kingdom
Singleton Hospital, Swansea, , United Kingdom
Contact Details
Name: Janet Graham
Affiliation: NHS Greater Glasgow and Clyde
Role: PRINCIPAL_INVESTIGATOR
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