Evidence map›Paper›PMID 36240478›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2023

FORT-1: Phase II/III Study of Rogaratinib Versus Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Selected Based on

Cora N Sternberg, Daniel P Petrylak, Joaquim Bellmunt, Hiroyuki Nishiyama, Andrea Necchi, Howard Gurney, Jae-Lyun Lee, Michiel S van der Heijden, Eli Rosenbaum, Nicolas Penel and 13 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03410693 (A Randomized, Open Label, Multicenter Phase 2/3 Study to Evaluate the Efficacy and Safety of Rogaratinib), which is not on this map. Cited by 66 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
66citing papers in PubMed, 2 pooled it
20.7field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03410693 phase2 / phase3completednot on this map

A Randomized, Open Label, Multicenter Phase 2/3 Study to Evaluate the Efficacy and Safety of Rogaratinib (BAY1163877) Compared to Chemotherapy in Patients With FGFR-positive Locally Advanced or Metastatic Urothelial Carcinoma Who Have Received Prior Platinum-containing Chemotherapy

TypeinterventionalSponsorBayerRan2018 to 2020Enrolled175ConditionsCarcinoma, Transitional CellArmsRogaratinib (BAY1163877), Chemotherapy
3 · Its place in the literature

Who cites it

66 citing papers in PubMed, 2 syntheses or guidelines pooled it, 90 citations in OpenAlex.

  1. Pooled it
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  7. Towards biomarker-driven therapies for urothelial carcinoma.Nature reviews. Clinical oncology · 2026
    Review
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6 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

23 authors at 19 institutions in 13 countries.

Cora N SternbergEnglander Institute for Precision Medicine, Weill Cornell Medicine, Sandra and Edward Meyer Cancer Center, New York, NY.ORCID 0000-0003-3938-2627
Daniel P PetrylakYale Cancer Center, New Haven, CT.ORCID 0000-0001-6165-5797
Joaquim BellmuntBeth Israel Deaconess Medical Center and PSMAR-IMIM Lab, Boston, MA.ORCID 0000-0003-2328-3421
Hiroyuki NishiyamaDepartment of Urology, University of Tsukuba, Tsukuba, Japan.
Andrea NecchiVita-Salute San Raffaele University and IRCCS San Raffaele Hospital and Scientific Institute, Milan, Italy.ORCID 0000-0002-3007-2756
Howard GurneyClinical Trials Unit FMHS, Macquarie University, Sydney, New South Wales, Australia.ORCID 0000-0003-0217-5261
Jae-Lyun LeeUniversity of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea.ORCID 0000-0002-9420-7162
Michiel S van der HeijdenMedical Oncology, the Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands.ORCID 0000-0002-4407-7881
Eli RosenbaumDavidoff Cancer Center, Rabin Medical Center, Petah Tikva, Israel.
Nicolas PenelLille University and Department of Medical Oncology, Centre Oscar Lambret, Lille, France.ORCID 0000-0001-5243-1548
See-Tong PangDivision of Urology, Department of Surgery, Linkou Chang Gung Memorial Hospital, Linkou, Taiwan.
Jian-Ri LiDivision of Urology, Department of Surgery, Taichung Veterans General Hospital, Taichung, Taiwan.ORCID 0000-0002-4626-9369
Xavier García Del MuroDepartment of Medical Oncology, University of Barcelona, Idibell Institute of Research, Institut Català d'Oncologia Hospitalet, Barcelona, Spain.ORCID 0000-0001-5571-2847
Florence JolyClinical Research Department, Centre François Baclesse, Caen, France.ORCID 0000-0001-7004-9895
Zsuzsanna PápaiOncology Department, Medical Centre, Hungarian Defence Forces, Budapest, Hungary.
Weichao BaoBayer HealthCare Pharmaceuticals, Inc, Whippany, NJ.
Peter EllinghausBayer AG, Wuppertal, Germany.
Chengxing LuBayer HealthCare Pharmaceuticals, Inc, Whippany, NJ.
Mitchell SiereckiBayer HealthCare Pharmaceuticals, Inc, Whippany, NJ.
Sabine CoppietersBayer AG, Diegem, Belgium.
Keiko NakajimaBayer HealthCare Pharmaceuticals, Inc, Whippany, NJ.
Tatiane Cristine IshidaBayer HealthCare Pharmaceuticals, Inc, Whippany, NJ.ORCID 0000-0002-2976-0295
David I QuinnDivision of Oncology, Department of Medicine, USC Norris Comprehensive Cancer Center, Los Angeles, CA.ORCID 0000-0002-1411-0417
Bayer (United States) · USBayer (Belgium) · BEBayer (Germany) · DEBeth Israel Deaconess Medical Center · USCentre François Baclesse · FRCentre Oscar Lambret · FRCornell University · USInstitut Català d'Oncologia · ESLinkou Chang Gung Memorial Hospital · TWMacquarie University · AURabin Medical Center · ILTaichung Veterans General Hospital · TWThe Netherlands Cancer Institute · NLUlsan College · KRUniversity of Tsukuba · JPUSC Norris Comprehensive Cancer Center · USVita-Salute San Raffaele University · ITYale Cancer Center · USZrínyi Miklós National Defence University · HU

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NCATS NIH HHS UL1 TR001863
6 · The paper itself

Abstract

purposeRogaratinib, an oral pan-fibroblast growth factor receptor (FGFR1-4) inhibitor, showed promising phase I efficacy and safety in patients with advanced urothelial carcinoma (UC) with

methodsFORT-1 (ClinicalTrials.gov identifier: NCT03410693) was a phase II/III, randomized, open-label trial. Patients with

resultsORRs were 20.7% (rogaratinib, 18/87; 95% CI, 12.7 to 30.7) and 19.3% (chemotherapy, 17/88; 95% CI, 11.7 to 29.1). Median overall survival was 8.3 months (95% CI, 6.5 to not estimable) and 9.8 months (95% CI, 6.8 to not estimable; hazard ratio, 1.11; 95% CI, 0.71 to 1.72;

conclusionTo our knowledge, these are the first data to compare FGFR-directed therapy with chemotherapy in patients with

Indexed as

Antineoplastic AgentsCarcinoma, Transitional CellUrinary Bladder NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsDNAHumansPiperazinesPlatinumPyrrolesReceptor, Fibroblast Growth Factor, Type 1RNA, MessengerThiophenesAntineoplastic AgentsDNAFGFR1 protein, humanPiperazinesPlatinumPyrrolesReceptor, Fibroblast Growth Factor, Type 1RNA, MessengerRogaratinibThiophenes

Identifiers

PMID36240478
PMCPMC9870218
OpenAlexW4306249353

What Socratic holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.