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Pharmaceutical company Roche is to sponsor a multi-country, Phase II, genomic profiling study to evaluate the efficacy of molecularly guided therapy versus platinum chemotherapy in CUP patients. Profiling will be based on the FoundationOne® assay.
It is intended that the trial should open in approximately 100 sites in 25 countries and will enroll 790 patients. Last week it was agreed, within Roche, that there would be UK participation.
The trial design is not yet finalised but is looking like 3 cycles of chemo induction followed by randomization of responders to either molecularly guided therapy or an additional 3 cycles of chemo.
Subject to national Ethics and other approvals, it is hoped to activate the first sites for patient screening/enrolment in the Spring of 2018.