Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma (FORT-1)

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

This is a randomized, open-label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFR-positive locally advanced or metastatic urothelial carcinoma who have received prior platinum-containing chemotherapy.

The primary objective is to demonstrate the superiority of rogaratinib over chemotherapy in terms of objective response rate (before: overall survivial) of urothelial carcinoma patients with FGFR positive tumors.

At randomization, patients will have locally advanced or metastatic urothelial carcinoma and have received at least one prior platinum-containing chemotherapy regimen. Only patients with FGFR1 or 3 positive tumors can be randomized into the study. Archival tumor tissue is adequate for testing of FGFR1 and 3 mRNA expressions, which will be determined centrally using an RNA in situ hybridization (RNA-ISH) test. Approximately 42 % of UC patients with locally advanced or metastatic UC are identified as FGFR-positive by the RNA-ISH cut-off applied.

Study Overview

• Status: Completed
• Conditions: Carcinoma, Transitional Cell
• Intervention / Treatment: Drug: Rogaratinib (BAY1163877); Drug: Chemotherapy

• Study Type: Interventional
• Enrollment (Actual): 175
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Coffs Harbour, New South Wales, Australia, 2450
      • Mid North Coast Cancer Institute
    • St Leonards, New South Wales, Australia, 2065
      • Northern Cancer Institute
    • Sydney, New South Wales, Australia, 2109
      • Macquarie University Hospital
    • Wagga Wagga, New South Wales, Australia, 2650
      • Riverina Cancer Care Centre
    • Wahroonga, New South Wales, Australia, 2076
      • Sydney Adventist Hospital
  • Queensland
    • Benowa, Queensland, Australia, 4217
      • Pindara Private Hospital
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Medical Centre
• Austria
  • Krems, Austria, 3500
    • Landesklinikum Krems
  • Wien, Austria, 1020
    • Krankenhaus der Barmherzigen Brüder
  • Wien, Austria, 1090
    • Universitätsklinikum AKH Wien
  • Wien, Austria, 1160
    • Klinik Ottakring - Wilhelminenspital
• Belgium
  • Gent, Belgium, 9000
    • UZ Gent
  • Leuven, Belgium, 3000
    • UZ Leuven Gasthuisberg
  • Ottignies, Belgium, 1340
    • Clinique Saint-Pierre
• Canada
  • Ottawa, Canada, K1H 8L6
    • Ottawa Hospital-General Campus
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Hospital-University Health Network
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Sir Mortimer B. Davis Jewish General Hospital
• China
  • Beijing, China, 100071
    • Fifth Medical Center, General Hospital of the Chinese People
  • Guangzhou, China
    • First Affiliated Hospital of Guangzhou Medical University
  • Shanghai, China, 200032
    • Fudan University Shanghai Cancer Center
  • Shanghai, China, 200040
    • Huadong Hospital, Affiliated to Fudan University
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Fujian Medical University Union Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-Sen University Cancer Center
  • Hubei
    • Wuhan, Hubei, China, 430079
      • Hubei Cancer Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School
    • Nanjing, Jiangsu, China, 210009
      • Jiangsu Cancer Hospital
  • Liaoning
    • Shengyang, Liaoning, China, 110042
      • Liaoning Cancer Hospital and Institute
• Czechia
  • Ostrava, Czechia, 708 52
    • Fakultni nemocnice Ostrava
  • Praha 10, Czechia, 10034
    • Fakultní nemocnice Královské Vinohrady
  • Praha 4 - Krc, Czechia, 140 59
    • Fakultni Thomayerova nemocnice
  • Zlin, Czechia, 762 75
    • Bata Hospital
• Denmark
  • Aarhus N, Denmark, 8200
    • Aarhus Universitetshospital, Skejby
  • Herlev, Denmark, 2730
    • Herlev Hospital - Oncology Research Dept.
  • København, Denmark, 2100
    • Rigshospitalet
• Finland
  • Helsinki, Finland, 00180
    • Docrates Klinikka
• France
  • Besancon, France, 25030
    • Hôpital Jean Minjoz
  • Bordeaux, France, 33000
    • Hôpital Saint André - Bordeaux
  • Caen Cedex 5, France, 14076
    • Centre de Lutte Contre le Cancer François Baclesse
  • Clermont Ferrand Cedex 1, France, 63011
    • Centre Jean Perrin
  • Lille Cedex, France, 59020
    • Centre Oscar Lambret - Lille
  • Lyon Cedex, France, 69008
    • Centre Léon Bérard
  • Marseille, France, 13273
    • Institut Paoli-Calmettes - Marseille
  • Paris, France, 75674
    • Cochin - Paris
  • Saint Mande, France, 94160
    • Hôpital d'Instruction des Armees Begin
  • Strasbourg, France, 67000
    • Clinique Saint Anne
  • Suresnes, France, 92151
    • Centre Médico-Chirurgical Foch
• Germany
  • Baden-Württemberg
    • Tübingen, Baden-Württemberg, Germany, 72076
      • Eberhard-Karls-Universität Tübingen
  • Nordrhein-Westfalen
    • Düsseldorf, Nordrhein-Westfalen, Germany, 40225
      • Heinrich-Heine-Universität Düsseldorf
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55131
      • Universitätsmedizin der Johannes Gutenberg Universität Mainz
• Hong Kong
  • Shatin, Hong Kong
    • Prince of Wales Hospital Hong Kong
• Hungary
  • Budapest, Hungary, 1122
    • Országos Onkológiai Intézet
  • Budapest, Hungary, 1062
    • MH Egészségügyi Központ
  • Pecs, Hungary, 7624
    • Pecsi Tudomanyegyetem Klinikai Kozpont
• Ireland
  • Cork, Ireland
    • Cork University Hospital
  • Dublin, Ireland, 24
    • AMNCH
• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Corporation
  • Jerusalem, Israel, 9112001
    • Hadassah Hebrew University Hospital Ein Kerem
  • Kfar Saba, Israel, 4428164
    • Meir Medical Center
  • Petah Tikva, Israel, 4941492
    • Clalit Health Services Rabin Medical Center-Beilinson Campus
  • Ramat Gan, Israel, 5266202
    • Chaim Sheba Medical Center
• Italy
  • Emilia-Romagna
    • Forlì Cesena, Emilia-Romagna, Italy, 47014
      • IRST Istituto Scientifico Romagnolo per studio e cura tumori
    • Modena, Emilia-Romagna, Italy, 41124
      • A.O.U. di Modena - Policlinico
    • Modena, Emilia-Romagna, Italy, 41012
      • AUSL Modena
  • Lazio
    • Roma, Lazio, Italy, 00152
      • A.O. San Camillo-Forlanini
    • Roma, Lazio, Italy, 00168
      • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Lombardia
    • Milano, Lombardia, Italy, 20133
      • Fondazione IRCCS Istituto Nazionale dei Tumori
    • Milano, Lombardia, Italy, 20141
      • IRCCS Istituto Europeo di Oncologia s.r.l. (IEO)
    • Milano, Lombardia, Italy, 20162
      • ASST Grande Ospedale Metropolitano Niguarda
  • Piemonte
    • Torino, Piemonte, Italy, 10043
      • A.O.U. San Luigi Gonzaga
  • Toscana
    • Pisa, Toscana, Italy, 56126
      • A.O.U. Pisana
  • Veneto
    • Verona, Veneto, Italy, 37134
      • A.O.U.I. Verona
• Japan
  • Akita, Japan, 010-8543
    • Akita University Hospital
  • Fukuoka, Japan, 812-8582
    • Kyushu University Hospital
  • Hiroshima, Japan, 730-8518
    • Hiroshima City Hiroshima Citizens Hospital
  • Kumamoto, Japan, 860-8556
    • Kumamoto University Hospital
  • Niigata, Japan, 951-8520
    • Niigata University Medical and Dental Hospital
  • Osaka, Japan, 541-8567
    • Osaka International Cancer Institute
  • Toyama, Japan, 930-0194
    • Toyama University Hospital
  • Aichi
    • Nagoya, Aichi, Japan, 466-8560
      • Nagoya University Hospital
  • Aomori
    • Hirosaki, Aomori, Japan, 036-8563
      • Hirosaki University Hospital
  • Gunma
    • Maebashi, Gunma, Japan, 371-8511
      • Gunma University Hospital
    • Ota, Gunma, Japan, 373-8550
      • Gunma Prefectural Cancer Center
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8543
      • Sapporo Medical University Hospital
    • Sapporo, Hokkaido, Japan, 060-8648
      • Hokkaido University Hospital
  • Hyogo
    • Kobe, Hyogo, Japan, 650-0047
      • Kobe City Medical Center General Hospital
  • Ibaraki
    • Tsukuba, Ibaraki, Japan, 305-8576
      • University of Tsukuba Hospital
  • Iwate
    • Morioka, Iwate, Japan, 028-3695
      • Iwate Medical University Hospital
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 236-0004
      • Yokohama City University Hospital
  • Osaka
    • Osakasayama, Osaka, Japan, 589-8511
      • Kindai University Hospital
  • Saitama
    • Hidaka, Saitama, Japan, 350-1298
      • Saitama Medical University International Medical Center
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8603
      • Nippon Medical School Hospital
    • Chuo-ku, Tokyo, Japan, 104-0045
      • National Cancer Center Hospital
    • Koto-ku, Tokyo, Japan, 135-8550
      • The Cancer Institute Hospital of JFCR
    • Shinjuku-ku, Tokyo, Japan, 160-8582
      • Keio University Hospital
• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Gyeonggido
    • Goyang-si, Gyeonggido, Korea, Republic of, 10408
      • National Cancer Center
• Netherlands
  • Amsterdam, Netherlands, 1066 CX
    • Nederlands Kanker Instituut
  • Rotterdam, Netherlands, 3075 EA
    • Erasmus Medisch Centrum
• Poland
  • Bydgoszcz, Poland, 85-796
    • Centrum Onkologii im. Prof. Franciszka Lukaszczyka
  • Kielce, Poland, 25-734
    • Swietokrzyskie Centrum Onkologii
  • Konin, Poland, 62-500
    • Przychodnia Lekarska KOMED
  • Olsztyn, Poland, 10-357
    • Samodzielny Publiczny Zespol Gruzlicy I Chorob Pluc
  • Poznan, Poland, 60-569
    • Szpital Kliniczny Przemienienia Pańskiego
  • Wroclaw, Poland, 50-556
    • Uniwersytecki Szpital Kliniczny UM we Wroclawiu
• Portugal
  • Coimbra, Portugal, 3000-075
    • IPO Coimbra
  • Lisboa, Portugal, 1649-035
    • CHULN - Hospital Santa Maria
  • Lisboa, Portugal, 1350-070
    • Hospital CUF Infante Santo
  • Porto, Portugal, 4099-001
    • Centro Hospitalar Universitario do Porto
  • Lisboa
    • Loures, Lisboa, Portugal, 2674-514
      • Hospital Beatriz Angelo
• Russian Federation
  • Krasnoyarsk, Russian Federation, 660133
    • Krasnoyarsk Regional Clinical Oncology Dispensary
  • Moscow, Russian Federation, 125284
    • Moscow Scient. Res. Institute of Oncology n.a P.A. Hertzen
  • Nizhny Novgorod, Russian Federation, 603109
    • Volga District Med Center FMBA
  • Omsk, Russian Federation, 644013
    • Clinical Oncological Dispensary of Omsk Region
  • Ufa, Russian Federation, 450008
    • Bashkir State Medical University
• Singapore
  • Singapore, Singapore, 119074
    • National University Hospital
  • Singapore, Singapore, 169610
    • National Cancer Center Singapore
• Slovakia
  • Bratislava, Slovakia, 833 10
    • Narodny Onkologicky Ustav
  • Nitra, Slovakia, 949 01
    • UROEXAM, spol. s r.o.
  • Poprad, Slovakia, 085 01
    • POKO Poprad s.r.o.
• Spain
  • Barcelona, Spain, 08003
    • Hospital Del Mar
  • Barcelona, Spain, 08035
    • Ciutat Sanitaria i Universitaria de la Vall d'Hebron
  • Cáceres, Spain, 10003
    • Hospital San Pedro de Alcantara
  • Córdoba, Spain, 14004
    • Hospital Reina Sofia
  • Madrid, Spain, 28041
    • Hospital Universitario 12 De Octubre
  • Madrid, Spain, 28034
    • Hospital Ramón y Cajal
  • Málaga, Spain, 29010
    • Hospital Virgen de la Victoria
  • Valencia, Spain, 46009
    • Instituto Valenciano de Oncologia
  • Valencia, Spain, 46014
    • Hospital General Universitario de Valencia
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Institut Català d'Oncologia Badalona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Institut Catala d'Oncologia Hospitalet
  • Illes Baleares
    • Palma de Mallorca, Illes Baleares, Spain, 07120
      • Hospital Universitari Son Espases
• Sweden
  • Stockholm, Sweden, 118 83
    • Södersjukhuset
  • Stockholm, Sweden, 17167
    • Karolinska Institutet
• Switzerland
  • Basel-Stadt
    • Basel, Basel-Stadt, Switzerland, 4031
      • Universitätsspital Basel
  • Graubünden
    • Chur, Graubünden, Switzerland, 7000
      • Kantonsspital Graubünden
  • Sankt Gallen
    • St. Gallen, Sankt Gallen, Switzerland, 9007
      • Kantonsspital St. Gallen
• Taiwan
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taoyuan, Taiwan, 33305
    • Chang Gung Memorial Hospital at Linkou
• United Kingdom
  • London, United Kingdom, SW3 6JJ
    • Royal Marsden Hospital (London)
  • Merseyside
    • Bebington, Merseyside, United Kingdom, CH63 4JY
      • Clatterbridge Centre for Oncology
• United States
  • Alaska
    • Anchorage, Alaska, United States, 99503
      • Alaska Clinical Research Center, LLC
  • Arizona
    • Tucson, Arizona, United States, 85719
      • University of Arizona Cancer Center
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California
    • Sacramento, California, United States, 95817
      • UC Davis Comprehensive Cancer Center
    • Santa Barbara, California, United States, 93105
      • Sansum Clinic
  • Colorado
    • Littleton, Colorado, United States, 80120-4413
      • Rocky Mountain Cancer Centers
  • Florida
    • Orlando, Florida, United States, 32806
      • UF Cancer Center at Orlando Health
  • Kansas
    • Westwood, Kansas, United States, 66205
      • University of Kansas Medical Center
  • Nevada
    • Las Vegas, Nevada, United States, 89169
      • Comprehensive Cancer Centers of Nevada
  • Oregon
    • Tigard, Oregon, United States, 97223
      • Compass Oncology
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Bon Secours St. Francis Hospital
  • Texas
    • Denton, Texas, United States, 76210
      • Texas Oncology-Denton South
    • Houston, Texas, United States, 77030-2707
      • Houston Methodist Hospital
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center
    • Spokane, Washington, United States, 99208
      • Summit Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Existence of archival or fresh biopsy for FGFR testing. Mandatory FGFR testing of patients will be performed prior to start of screening. The timing of the FGFR test is at the discretion of the investigator. Investigators should ensure all patients will be eligible in terms of disease status and lines of treatment.

• Documented urothelial carcinoma (transitional cell carcinoma) including urinary bladder, renal pelvis, ureters, urethra meeting all of the following criteria

  • Histologically confirmed (Patients with mixed histologies are required to have a dominant transitional cell pattern.)
  • Locally advanced (T4, any N; or any T, N 2-3) or metastatic disease (any T, any N and M1). Locally advanced bladder cancer must be unresectable i.e. invading the pelvic or abdominal wall (stage T4b) or presenting with bulky nodal disease (N2-3).
• ECOG (Eastern Cooperative Oncology Group) Performance Status of 0 or 1
• Disease progression during or following treatment with at least one platinum-containing regimen (patients should have been treated for at least 2 cycles). In patients who received prior adjuvant/ neoadjuvant platinum-containing chemotherapy, progression had to occur within 12 months of treatment.
• High FGFR1 or 3 mRNA expression levels in archival or fresh tumor biopsy specimen quantified as outlined in the lab manual
• At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST v.1.1) in contrast enhanced (unless contraindicated) CT or MRI

Exclusion Criteria:

• Previous or concurrent cancer except

  • cervical carcinoma in situ
  • treated basal-cell or squamous cell skin carcinoma
  • any cancer curatively treated > 3 years before randomization
  • curatively treated incidental prostate cancer (T1/T2a)
• Ongoing or previous treatment with anti-FGFR directed therapies (e.g. receptor tyrosine kinase inhibitors including rogaratinib or FGFR-specific antibodies) or with taxanes or vinflunine
• More than two prior lines of systemic anti-cancer therapy for urothelial carcinoma given for advanced unresectable/ metastatic disease
• Ongoing or previous anti-cancer treatment within 4 weeks before randomization.
• Unresolved toxicity higher than National Cancer Institute's Common Terminology Criteria for Adverse Events, version 4.03 (CTCAE v.4.03) Grade 1 attributed to any prior therapy/ procedure excluding alopecia, anemia and/ or hypothyroidism

• History or current condition of an uncontrolled cardiovascular disease including any of the following conditions:

  • Congestive heart failure (CHF) NYHA (New York Heart Association) > Class 2
  • Unstable angina (symptoms of angina at rest) or new-onset angina (within last 3 months before randomization)
  • Myocardial infarction (MI) within past 6 months before randomization
  • Unstable cardiac arrhythmias requiring anti-arrhythmic therapy. Patients with arrhythmia under control with anti-arrhythmic therapy such as beta-blockers or digoxin are eligible.
• Arterial or venous thrombotic events or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before randomization
• Current evidence of endocrine alteration of calcium phosphate homeostasis (e.g. parathyroid disorder, history of parathyroidectomy, tumor lysis, tumoral calcinosis, paraneoplastic hypercalcemia)
• Current diagnosis of any retinal detachment, retinal pigment epithelial detachment (RPED), serous retinopathy or retinal vein occlusion
• Any hemorrhage / bleeding event ≥ CTCAE v.4.03 Grade 3 within 4 weeks before randomization

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rogaratinib; Rogaratinib treatment study arm, comprising; Pre-treatment period, including FGFR testing and screening,; Treatment period, and; Follow-up period, including active follow-up and long-term follow-up. Patients will be considered "on study" during the pre-treatment, treatment and active followup periods. During the long-term follow-up period the patients will be considered "off study".	Drug: Rogaratinib (BAY1163877); Rogaratinib administered as oral (p.o.) tablets twice daily (b.i.d.) continuously
Active Comparator: Chemotherapy; Chemotherapy treatment study arm, comprising; Pre-treatment period, including FGFR testing and screening,; Treatment period, and; Follow-up period, including active follow-up and long-term follow-up. Patients will be considered "on study" during the pre-treatment, treatment and active followup periods. During the long-term follow-up period the patients will be considered "off study".	Drug: Chemotherapy; Chemotherapy as taxane (docetaxel or paclitaxel) or vinflunine administered through intravenous (i.v.) infusion every 3 weeks (on day 1 of a 21-day cycle) The choice of the chemotherapy is at the discretion of the investigator, taking into consideration the status of the authorization or treatment guidelines in the given country.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) - Central Assessment	ORR is defined as the percentage of participants with complete response (CR) or partial response (PR). participants for whom overall best response is not CR or PR, as well as participants without any post-baseline tumor assessment will be considered non-responders.	From start of treatment up to end of active follow-up, approximately 29 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-control Rate (DCR) - Central Assessment	DCR was defined as the percentage of participants whose overall best response was not a progressive disease (i.e., CR, PR, stable disease [SD] or Non CR/Non PD).	From start of treatment till end of active follow-up, approximately 29 months
Progression-free Survival (PFS) - Central Assessment	Progression free survival (PFS) was defined as the time (days) from randomization to date of first observed disease progression (radiological or clinical assessment or both) or death due to any cause (if death occurred before progression was documented).	From start of treatment till end of active follow-up, approximately 29 months
Duration of Response (DOR) - Central Assessment	DOR (for patients with PR and CR only) was defined as the time from the first documented objective response of PR or CR, whichever was noted earlier, to disease progression (including symptomatic deterioration) or death, whichever was earlier	From start of treatment till end of active follow-up, approximately 29 months
Number of Participants With Treatment Emergent Adverse Events	A treatment-emergent event was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment	From start of treatment up to 30 days after the last administration of study treatment, approximately 29 months

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

General Publications

• Sternberg CN, Petrylak DP, Bellmunt J, Nishiyama H, Necchi A, Gurney H, Lee JL, van der Heijden MS, Rosenbaum E, Penel N, Pang ST, Li JR, Garcia Del Muro X, Joly F, Papai Z, Bao W, Ellinghaus P, Lu C, Sierecki M, Coppieters S, Nakajima K, Ishida TC, Quinn DI. FORT-1: Phase II/III Study of Rogaratinib Versus Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Selected Based on FGFR1/3 mRNA Expression. J Clin Oncol. 2022 Oct 14:JCO2102303. doi: 10.1200/JCO.21.02303. Online ahead of print.
• Grunewald S, Politz O, Bender S, Heroult M, Lustig K, Thuss U, Kneip C, Kopitz C, Zopf D, Collin MP, Boemer U, Ince S, Ellinghaus P, Mumberg D, Hess-Stumpp H, Ziegelbauer K. Rogaratinib: A potent and selective pan-FGFR inhibitor with broad antitumor activity in FGFR-overexpressing preclinical cancer models. Int J Cancer. 2019 Sep 1;145(5):1346-1357. doi: 10.1002/ijc.32224. Epub 2019 Mar 13.

Helpful Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.
• Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2018
• Primary Completion (Actual): October 27, 2020
• Study Completion (Actual): October 27, 2020

Study Registration Dates

• First Submitted: January 19, 2018
• First Submitted That Met QC Criteria: January 19, 2018
• First Posted (Actual): January 25, 2018

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 25, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Urothelial carcinoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Carcinoma, Transitional Cell
• Other Study ID Numbers: 17403 (Other Identifier: City of Hope Medical Center); 2016-004340-11 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No