%0 Journal Article
%A Pal, Sumanta K
%A Somford, Diederik M
%A Grivas, Petros
%A Sridhar, Srikala S
%A Gupta, Shilpa
%A Bellmunt, Joaquim
%A Sonpavde, Guru
%A Fleming, Mark T
%A Lerner, Seth P
%A Loriot, Yohann
%A Hoffman-Censits, Jean
%A Valderrama, Begoña P
%A Andresen, Corina
%A Schnabel, Marco J
%A Cole, Suzanne
%A Daneshmand, Siamak
%T Targeting FGFR3 alterations with adjuvant infigratinib in invasive urothelial carcinoma: the phase III PROOF 302 trial.
%D 2022
%U http://hdl.handle.net/10668/20492
%X PROOF 302 is an ongoing randomized, double-blind, placebo-controlled, adjuvant phase III trial (NCT04197986) in approximately 218 patients from 120 centers worldwide. Eligibility criteria include post-surgical high-risk muscle-invasive upper tract urothelial cancer (85% of patients) or urothelial bladder cancer (15%), susceptible FGFR3 alterations (activating mutations, gene fusions or rearrangements), ≤120 days following radical surgery and ineligible for/or refusing cisplatin-based (neo)adjuvant chemotherapy. Patients receive either oral infigratinib 125 mg or placebo daily on days 1-21 of a 28-day cycle for up to 52 weeks or until recurrence, unacceptable toxicity or death. Primary end point: centrally determined disease-free survival (DFS); secondary end points: investigator-assessed DFS, metastasis-free survival, overall survival and safety/tolerability; exploratory end points: correlative biomarker analysis, quality-of-life and infigratinib pharmacokinetics.
%K FGFR inhibitor
%K FGFR3
%K PROOF 302
%K adjuvant cisplatin-based chemotherapy
%K adjuvant therapy
%K cisplatin-therapy refusal
%K fusions or rearrangements
%K infigratinib
%K muscle-invasive urothelial carcinoma
%K mutations
%K neoadjuvant cisplatin-based chemotherapy
%K phase III
%K upper tract urothelial carcinoma
%K urothelial bladder carcinoma
%K urothelial carcinoma
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