Targeting FGFR3 alterations with adjuvant infigratinib in invasive urothelial carcinoma: the phase III PROOF 302 trial
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- dc.contributor.author Pal, Sumanta
- dc.contributor.author Somford, Diederik M.
- dc.contributor.author Grivas, Petros
- dc.contributor.author Sridhar, Srikala S.
- dc.contributor.author Gupta, Shilpa
- dc.contributor.author Bellmunt Molins, Joaquim, 1959-
- dc.contributor.author Sonpavde, Guru
- dc.contributor.author Fleming, Mark T.
- dc.contributor.author Lerner, Seth Paul
- dc.contributor.author Loriot, Yohann
- dc.contributor.author Hoffman-Censits, Jean
- dc.contributor.author Valderrama, Begoña P.
- dc.contributor.author Andresen, Corina
- dc.contributor.author Schnabel, Marco J.
- dc.contributor.author Cole, Suzanne
- dc.contributor.author Daneshmand, Siamak
- dc.date.accessioned 2023-02-15T07:29:12Z
- dc.date.available 2023-02-15T07:29:12Z
- dc.date.issued 2022
- dc.description.abstract 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.
- dc.format.mimetype application/pdf
- dc.identifier.citation Pal SK, Somford DM, Grivas P, Sridhar SS, Gupta S, Bellmunt J, et al. Targeting FGFR3 alterations with adjuvant infigratinib in invasive urothelial carcinoma: the phase III PROOF 302 trial. Future Oncol. 2022 Jul; 18(21): 2599-614. DOI: 10.2217/fon-2021-1629
- dc.identifier.doi http://dx.doi.org/10.2217/fon-2021-1629
- dc.identifier.issn 1479-6694
- dc.identifier.uri http://hdl.handle.net/10230/55778
- dc.language.iso eng
- dc.publisher Future Medicine
- dc.rights This work is licensed under the Attribution-NonCommercial-NoDerivatives 4.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-nd/4.0/
- dc.rights.accessRights info:eu-repo/semantics/openAccess
- dc.rights.uri http://creativecommons.org/licenses/by-nc-nd/4.0/
- dc.subject.keyword FGFR inhibitor
- dc.subject.keyword FGFR3
- dc.subject.keyword PROOF 302
- dc.subject.keyword Adjuvant cisplatin-based chemotherapy
- dc.subject.keyword Adjuvant therapy
- dc.subject.keyword Cisplatin-therapy refusal
- dc.subject.keyword Fusions or rearrangements
- dc.subject.keyword Infigratinib
- dc.subject.keyword Muscle-invasive urothelial carcinoma
- dc.subject.keyword Mutations
- dc.subject.keyword Neoadjuvant cisplatin-based chemotherapy
- dc.subject.keyword Phase III
- dc.subject.keyword Upper tract urothelial carcinoma
- dc.subject.keyword Urothelial bladder carcinoma
- dc.subject.keyword Urothelial carcinoma
- dc.title Targeting FGFR3 alterations with adjuvant infigratinib in invasive urothelial carcinoma: the phase III PROOF 302 trial
- dc.type info:eu-repo/semantics/article
- dc.type.version info:eu-repo/semantics/publishedVersion