Trial Condition(s):
Carcinoma, Transitional Cell
Study of rogaratinib (BAY1163877) vs chemotherapy in patients with FGFR (Fibroblast growth factor receptor)-positive locally advanced or metastatic urothelial carcinoma (FORT-1)
Bayer Identifier:
17403
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
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Locations Hospital del Mar Barcelona, Spain, 08003 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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Locations Hospital Ramón y Cajal Madrid, Spain, 28034 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Universitari Son Espases Palma de Mallorca, Spain, 07120 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Virgen de la Victoria Málaga, Spain, 29010 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Instituto Valenciano de Oncología Valencia, Spain, 46009 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Reina Sofía Córdoba, Spain, 14004 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Institut Català d'Oncologia Badalona Badalona, Spain, 08916 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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Locations Hospital General Universitario de Valencia Valencia, Spain, 46014 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Narodny onkologicky ustav Bratislava, Slovakia, 833 10 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations POKO Poprad s.r.o. Poprad, Slovakia, 085 01 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations UROEXAM, spol. s r.o. Nitra, Slovakia, 949 01 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Asan Medical Center Seoul, South Korea, 05505 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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Locations National Cancer Center Goyang-si, South Korea, 10408 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fondazione IRCCS Istituto Nazionale dei Tumori Milano, Italy, 20133 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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Locations A.O.U. Pisana Pisa, Italy, 56126 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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Locations A.O.U. San Luigi Gonzaga Torino, Italy, 10043 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma, Italy, 00168 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations A.O.U.I. Verona Verona, Italy, 37134 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations A.O.U. di Modena - Policlinico Modena, Italy, 41124 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations AUSL Modena Modena, Italy, 41012 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kantonsspital Graubünden Chur, Switzerland, 7000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Universitätsspital Basel Basel, Switzerland, 4031 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Prince of Wales Hospital Hong Kong Shatin, Hong Kong, China | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Universitätsklinikum AKH Wien Wien, Austria, 1090 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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Locations Klinik Ottakring - Wilhelminenspital Wien, Austria, 1160 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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Locations Taipei Veterans General Hospital Taipei, Taiwan, China, 11217 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Chang Gung Memorial Hospital at Linkou Taoyuan, Taiwan, China, 33305 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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Locations National Taiwan University Hospital Taipei, Taiwan, China, 10002 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations National University Hospital Singapore, Singapore, 119074 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations National Cancer Center Singapore Singapore, Singapore, 169610 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hopital Jean Minjoz BESANCON, France, 25030 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Cochin - Paris PARIS, France, 75674 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Centre Oscar Lambret - Lille LILLE CEDEX, France, 59020 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Centre Léon Bérard LYON CEDEX, France, 69008 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Centre de Lutte Contre le Cancer François Baclesse CAEN CEDEX 5, France, 14076 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Institut Paoli-Calmettes - Marseille MARSEILLE, France, 13273 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Princess Margaret Hospital-University Health Network Toronto, Canada, M5G 2M9 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fakultni Thomayerova Nemocnice Praha 4 - Krc, Czech Republic, 140 59 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fakultni nemocnice Kralovske Vinohrady Praha 10, Czech Republic, 10034 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fakultni nemocnice Ostrava Ostrava, Czech Republic, 708 52 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hadassah Hebrew University Hospital Ein Kerem Jerusalem, Israel, 9112001 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Clalit Health Services Rabin Medical Center-Beilinson Campus Petah Tikva, Israel, 4941492 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Chaim Sheba Medical Center Ramat Gan, Israel, 5266202 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Meir Medical Center Kfar Saba, Israel, 4428164 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Rambam Health Corporation Haifa, Israel, 3109601 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Moscow Scient. Res. Institute of Oncology n.a P.A. Hertzen Moscow, Russia, 125284 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Bashkir State Medical University Ufa, Russia, 450008 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Clinical Oncological Dispensary of Omsk Region Omsk, Russia, 644013 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Krasnoyarsk Regional Clinical Oncology Dispensary Krasnoyarsk, Russia, 660133 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Volga District Med Center FMBA Nizhny Novgorod, Russia, 603109 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Universitario 12 de Octubre Madrid, Spain, 28041 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Centro Hospitalar Universitario do Porto Porto, Portugal, 4099-001 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations IPO Coimbra Coimbra, Portugal, 3000-075 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations CHULN - Hospital Santa Maria Lisboa, Portugal, 1649-035 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Beatriz Angelo Loures, Portugal, 2674-514 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Rigshospitalet København, Denmark, 2100 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Herlev Hospital - Oncology Research Dept. Herlev, Denmark, 2730 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Aarhus Universitetshospital, Skejby Aarhus N, Denmark, 8200 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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Locations Kantonsspital St. Gallen St. Gallen, Switzerland, 9007 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Docrates Klinikka Helsinki, Finland, 00180 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hôpital Saint André - Bordeaux BORDEAUX, France, 33000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Clinique Saint Anne STRASBOURG, France, 67000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hôpital d'Instruction des Armées Begin SAINT MANDE, France, 94160 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Centre Médico-Chirurgical Foch SURESNES, France, 92151 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations AMNCH Dublin, Ireland, 24 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Cork University Hospital Cork, Ireland | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Alaska Clinical Research Center, LLC Anchorage, United States, 99503 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations University of Arizona Cancer Center Tuscon, United States, 85719 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Northern Cancer Institute St Leonards, Australia, 2065 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Macquarie University Hospital Sydney, Australia, 2109 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Mid North Coast Cancer Institute Coffs Harbour, Australia, 2450 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Monash Medical Centre Clayton, Australia, 3168 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Pindara Private Hospital Benowa, Australia, 4217 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Riverina Cancer Care Centre Wagga Wagga, Australia, 2650 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Eberhard-Karls-Universität Tübingen Tübingen, Germany, 72076 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Heinrich-Heine-Universität Düsseldorf Düsseldorf, Germany, 40225 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Universitätsmedizin der Johannes Gutenberg Universität Mainz Mainz, Germany, 55131 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital CUF Infante Santo Lisboa, Portugal, 1350-070 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Södersjukhuset Stockholm, Sweden, 118 83 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Centrum Onkologii im. Prof. Franciszka Lukaszczyka Bydgoszcz, Poland, 85-796 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Uniwersytecki Szpital Kliniczny UM we Wroclawiu Wroclaw, Poland, 50-556 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Swietokrzyskie Centrum Onkologii Kielce, Poland, 25-734 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc Olsztyn, Poland, 10-357 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Przychodnia Lekarska KOMED Konin, Poland, 62-500 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Szpital Kliniczny Przemienienia Panskiego Poznan, Poland, 60-569 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Orszagos Onkologiai Intezet Budapest, Hungary, 1122 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Pecsi Tudomanyegyetem Klinikai Kozpont Pecs, Hungary, 7624 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations MH Egeszsegugyi Kozpont Budapest, Hungary, 1062 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Virginia Mason Medical Center Seattle, United States, 98101 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations UC Davis Comprehensive Cancer Center Sacramento, United States, 95817 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations UZ Gent GENT, Belgium, 9000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Clinique Saint-Pierre OTTIGNIES, Belgium, 1340 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations UZ Leuven Gasthuisberg LEUVEN, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Royal Marsden Hospital (London) London, United Kingdom, SW3 6JJ | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations University of Kansas Medical Center Westwood, United States, 66205 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Houston Methodist Hospital Houston, United States, 77030-2707 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations University of Southern California Los Angeles, United States, 90033 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Sapporo Medical University Hospital Sapporo, Japan, 060-8543 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hirosaki University Hospital Hirosaki, Japan, 036-8563 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Iwate Medical University Hospital Morioka, Japan, 028-3695 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Niigata University Medical and Dental Hospital Niigata, Japan, 951-8520 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations University of Tsukuba Hospital Tsukuba, Japan, 305-8576 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations The Cancer Institute Hospital of JFCR Koto-ku, Japan, 135-8550 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Nagoya University Hospital Nagoya, Japan, 466-8560 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Osaka International Cancer Institute Osaka, Japan, 541-8567 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kindai University Hospital Osakasayama, Japan, 589-8511 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hiroshima City Hiroshima Citizens Hospital Hiroshima, Japan, 730-8518 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kyushu University Hospital Fukuoka, Japan, 812-8582 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hokkaido University Hospital Sapporo, Japan, 060-8648 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Gunma Prefectural Cancer Center Ota, Japan, 373-8550 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Saitama Medical University International Medical Center Hidaka, Japan, 350-1298 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Keio University Hospital Shinjuku-ku, Japan, 160-8582 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations National Cancer Center Hospital Chuo-ku, Japan, 104-0045 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Nippon Medical School Hospital Bunkyo-ku, Japan, 113-8603 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Yokohama City University Hospital Yokohama, Japan, 236-0004 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Toyama University Hospital Toyama, Japan, 930-0194 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kobe City Medical Center General Hospital Kobe, Japan, 650-0047 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kumamoto University Hospital Kumamoto, Japan, 860-8556 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ottawa Hospital-General Campus Ottawa, Canada, K1H 8L6 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Sydney Adventist Hospital Wahroonga, Australia, 2076 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Erasmus Medisch Centrum ROTTERDAM, Netherlands, 3075 EA | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Nederlands Kanker Instituut AMSTERDAM, Netherlands, 1066 CX | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations ASST Grande Ospedale Metropolitano Niguarda Milano, Italy, 20162 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Sir Mortimer B. Davis Jewish General Hospital Montreal, Canada, H3T 1E2 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Centre Jean Perrin CLERMONT FERRAND CEDEX 1, France, 63011 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Gunma University Hospital Maebashi, Japan, 371-8511 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Karolinska Institutet Stockholm, Sweden, 17167 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Akita University Hospital Akita, Japan, 010-8543 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Bon Secours St. Francis Hospital Greenville, United States, 29607 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Bata Hospital Zlin, Czech Republic, 762 75 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Clatterbridge Centre for Oncology Bebington, United Kingdom, CH63 4JY | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Comprehensive Cancer Centers of Nevada Las Vegas, United States, 89169 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Sansum Clinic Santa Barbara, United States, 93105 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations University of Pittsburgh Pittsburgh, United States, 15232 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fudan University Shanghai Cancer Center Shanghai, China, 200032 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Liaoning Cancer Hospital and Institute Shengyang, China, 110042 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Jiangsu Cancer Hospital Nanjing, China, 210009 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations UF Cancer Center at Orlando Health Orlando, United States, 32806 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations First Affiliated Hospital of Guangzhou Medical University Guangzhou, China | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations FuJian Medical University Union Hospital Fuzhou, China, 350001 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Huadong Hospital, Affiliated to Fudan University Shanghai, China, 200040 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fifth Medical Center, General Hospital of the Chinese People Beijing, China, 100071 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Sun Yat-sen University Cancer Center Guangzhou, China, 510060 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School Nanjing, China, 210008 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hubei Cancer Hospital Wuhan, China, 430079 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Summit Cancer Center Spokane, United States, 99208 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Rocky Mountain Cancer Centers Littleton, United States, 80120-4413 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Texas Oncology-Denton South Denton, United States, 76210 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Compass Oncology Tigard, United States, 97223 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Objective response rate (ORR) - central assessmentORR 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.Timeframe: From start of treatment up to end of active follow-up
Secondary Outcome
- Progression-free survival (PFS) - central assessmentProgression 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).Timeframe: From start of treatment till end of active follow-up
- Disease-control rate (DCR) - central assessmentDCR 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).Timeframe: From start of treatment till end of active follow-up
- Duration of response (DOR) - central assessmentDOR (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 earlierTimeframe: From start of treatment till end of active follow-up
- Number of participants with treatment emergent adverse eventsA treatment-emergent event is defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.Timeframe: From start of treatment up to 30 days after the last administration of study treatment
Additional Information
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