PRIMUS 004
Research type
Research Study
Full title
PRIMUS 004: A multi-arm non-comparative signal seeking phase II platform trial of biomarker-directed novel second-line treatments in metastatic pancreatic cancer
IRAS ID
255251
Contact name
David Chang
Contact email
Sponsor organisation
NHS Greater Glasgow and Clyde Health Board
Eudract number
2018-003971-37
ISRCTN Number
ISRCTN16004234
Duration of Study in the UK
3 years, 11 months, 30 days
Research summary
The aim of PRIMUS-004 is to offer a range of second-line treatment arms with extensive molecular profiling and evaluation of candidate selection biomarkers, as outlined in the Precision-Panc Master Protocol. Suitable patients would be those with advanced pancreatic cancer, previously treated with chemotherapy. The platform structure, under which will sit multiple individual signal seeking trial components, will provide a framework for second-line treatments to be investigated with a flexible, yet statistically-structured design. Initially, treatment appendices will include all biomarker subgroups, but an adaptive and flexible design will allow subsequent focused recruitment or stoppage in particular subgroups based on the observed results. The outcomes of the signal seeking arms will provide assistance on the design of larger, later phase randomised trial. This design also provides patients and clinicians with attractive treatment options in a situation where current best treatment options are limited and studies are hampered by the aggressiveness of pancreatic cancer, where a majority of patients deteriorate rapidly upon progression on first-line therapy.
At present we have one appendix, AZD6738 + Olaparib, this will be Appendix I.REC name
West of Scotland REC 1
REC reference
20/WS/0091
Date of REC Opinion
16 Jul 2020
REC opinion
Further Information Favourable Opinion