Targeting FGFR3 alterations with adjuvant infigratinib in invasive urothelial carcinoma: the phase III PROOF 302 trial

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 bl...

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Autores: Pal, Sumanta, Somford, Diederik M., Grivas, Petros, Sridhar, Srikala S., Gupta, Shilpa, Bellmunt Molins, Joaquim, 1959-, Sonpavde, Guru, Fleming, Mark T., Lerner, Seth Paul, Loriot, Yohann, Hoffman-Censits, Jean, Valderrama, Begoña P., Andresen, Corina, Schnabel, Marco J., Cole, Suzanne, Daneshmand, Siamak
Formato: artículo
Estado:Versión publicada
Fecha de publicación:2022
País:España
Recursos:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositorio:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.cat:10230/55778
Acesso em linha:http://hdl.handle.net/10230/55778
http://dx.doi.org/10.2217/fon-2021-1629
Access Level:acceso abierto
Palavra-chave:FGFR inhibitor
FGFR3
PROOF 302
Adjuvant cisplatin-based chemotherapy
Adjuvant therapy
Cisplatin-therapy refusal
Fusions or rearrangements
Infigratinib
Muscle-invasive urothelial carcinoma
Mutations
Neoadjuvant cisplatin-based chemotherapy
Phase III
Upper tract urothelial carcinoma
Urothelial bladder carcinoma
Urothelial carcinoma
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network_name_str España
repository_id_str
spelling Targeting FGFR3 alterations with adjuvant infigratinib in invasive urothelial carcinoma: the phase III PROOF 302 trialPal, SumantaSomford, Diederik M.Grivas, PetrosSridhar, Srikala S.Gupta, ShilpaBellmunt Molins, Joaquim, 1959-Sonpavde, GuruFleming, Mark T.Lerner, Seth PaulLoriot, YohannHoffman-Censits, JeanValderrama, Begoña P.Andresen, CorinaSchnabel, Marco J.Cole, SuzanneDaneshmand, SiamakFGFR inhibitorFGFR3PROOF 302Adjuvant cisplatin-based chemotherapyAdjuvant therapyCisplatin-therapy refusalFusions or rearrangementsInfigratinibMuscle-invasive urothelial carcinomaMutationsNeoadjuvant cisplatin-based chemotherapyPhase IIIUpper tract urothelial carcinomaUrothelial bladder carcinomaUrothelial carcinomaPROOF 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.Future Medicine202320232022info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttp://hdl.handle.net/10230/55778http://dx.doi.org/10.2217/fon-2021-1629reponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésThis 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/http://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:recercat.cat:10230/557782026-05-29T05:05:01Z
dc.title.none.fl_str_mv Targeting FGFR3 alterations with adjuvant infigratinib in invasive urothelial carcinoma: the phase III PROOF 302 trial
title Targeting FGFR3 alterations with adjuvant infigratinib in invasive urothelial carcinoma: the phase III PROOF 302 trial
spellingShingle Targeting FGFR3 alterations with adjuvant infigratinib in invasive urothelial carcinoma: the phase III PROOF 302 trial
Pal, Sumanta
FGFR inhibitor
FGFR3
PROOF 302
Adjuvant cisplatin-based chemotherapy
Adjuvant therapy
Cisplatin-therapy refusal
Fusions or rearrangements
Infigratinib
Muscle-invasive urothelial carcinoma
Mutations
Neoadjuvant cisplatin-based chemotherapy
Phase III
Upper tract urothelial carcinoma
Urothelial bladder carcinoma
Urothelial carcinoma
title_short Targeting FGFR3 alterations with adjuvant infigratinib in invasive urothelial carcinoma: the phase III PROOF 302 trial
title_full Targeting FGFR3 alterations with adjuvant infigratinib in invasive urothelial carcinoma: the phase III PROOF 302 trial
title_fullStr Targeting FGFR3 alterations with adjuvant infigratinib in invasive urothelial carcinoma: the phase III PROOF 302 trial
title_full_unstemmed Targeting FGFR3 alterations with adjuvant infigratinib in invasive urothelial carcinoma: the phase III PROOF 302 trial
title_sort Targeting FGFR3 alterations with adjuvant infigratinib in invasive urothelial carcinoma: the phase III PROOF 302 trial
dc.creator.none.fl_str_mv Pal, Sumanta
Somford, Diederik M.
Grivas, Petros
Sridhar, Srikala S.
Gupta, Shilpa
Bellmunt Molins, Joaquim, 1959-
Sonpavde, Guru
Fleming, Mark T.
Lerner, Seth Paul
Loriot, Yohann
Hoffman-Censits, Jean
Valderrama, Begoña P.
Andresen, Corina
Schnabel, Marco J.
Cole, Suzanne
Daneshmand, Siamak
author Pal, Sumanta
author_facet Pal, Sumanta
Somford, Diederik M.
Grivas, Petros
Sridhar, Srikala S.
Gupta, Shilpa
Bellmunt Molins, Joaquim, 1959-
Sonpavde, Guru
Fleming, Mark T.
Lerner, Seth Paul
Loriot, Yohann
Hoffman-Censits, Jean
Valderrama, Begoña P.
Andresen, Corina
Schnabel, Marco J.
Cole, Suzanne
Daneshmand, Siamak
author_role author
author2 Somford, Diederik M.
Grivas, Petros
Sridhar, Srikala S.
Gupta, Shilpa
Bellmunt Molins, Joaquim, 1959-
Sonpavde, Guru
Fleming, Mark T.
Lerner, Seth Paul
Loriot, Yohann
Hoffman-Censits, Jean
Valderrama, Begoña P.
Andresen, Corina
Schnabel, Marco J.
Cole, Suzanne
Daneshmand, Siamak
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv FGFR inhibitor
FGFR3
PROOF 302
Adjuvant cisplatin-based chemotherapy
Adjuvant therapy
Cisplatin-therapy refusal
Fusions or rearrangements
Infigratinib
Muscle-invasive urothelial carcinoma
Mutations
Neoadjuvant cisplatin-based chemotherapy
Phase III
Upper tract urothelial carcinoma
Urothelial bladder carcinoma
Urothelial carcinoma
topic FGFR inhibitor
FGFR3
PROOF 302
Adjuvant cisplatin-based chemotherapy
Adjuvant therapy
Cisplatin-therapy refusal
Fusions or rearrangements
Infigratinib
Muscle-invasive urothelial carcinoma
Mutations
Neoadjuvant cisplatin-based chemotherapy
Phase III
Upper tract urothelial carcinoma
Urothelial bladder carcinoma
Urothelial carcinoma
description 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.
publishDate 2022
dc.date.none.fl_str_mv 2022
2023
2023
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/10230/55778
http://dx.doi.org/10.2217/fon-2021-1629
url http://hdl.handle.net/10230/55778
http://dx.doi.org/10.2217/fon-2021-1629
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv http://creativecommons.org/licenses/by-nc-nd/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv http://creativecommons.org/licenses/by-nc-nd/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Future Medicine
publisher.none.fl_str_mv Future Medicine
dc.source.none.fl_str_mv reponame:Recercat. Dipósit de la Recerca de Catalunya
instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
instname_str Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
reponame_str Recercat. Dipósit de la Recerca de Catalunya
collection Recercat. Dipósit de la Recerca de Catalunya
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15,812429

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