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
| Locations | Status | |
|---|---|---|
Locations Hospital del Mar Barcelona, Spain, 08003 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ciutat Sanitària i Universitaria de la Vall d'Hebron Barcelona, Spain, 08035 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Ramón y Cajal Madrid, Spain, 28034 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Universitari Son Espases Palma de Mallorca, Spain, 07120 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Virgen de la Victoria Málaga, Spain, 29010 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Instituto Valenciano de Oncología Valencia, Spain, 46009 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Reina Sofía Córdoba, Spain, 14004 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Institut Català d'Oncologia Badalona Badalona, Spain, 08916 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital San Pedro de Alcántara Cáceres, Spain, 10003 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital General Universitario de Valencia Valencia, Spain, 46014 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Narodny onkologicky ustav Bratislava, Slovakia, 833 10 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations POKO Poprad s.r.o. Poprad, Slovakia, 085 01 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations UROEXAM, spol. s r.o. Nitra, Slovakia, 949 01 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Asan Medical Center Seoul, South Korea, 05505 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Severance Hospital, Yonsei University Health System Seoul, South Korea, 03722 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Samsung Medical Center Seoul, South Korea, 06351 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations National Cancer Center Goyang-si, South Korea, 10408 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fondazione IRCCS Istituto Nazionale dei Tumori Milano, Italy, 20133 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations A.O. San Camillo-Forlanini Roma, Italy, 00152 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations IRCCS Istituto Europeo di Oncologia s.r.l. (IEO) Milano, Italy, 20141 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations A.O.U. Pisana Pisa, Italy, 56126 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations IRST Istituto Scientifico Romagnolo per studio e cura tumori Forlì Cesena, Italy, 47014 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations A.O.U. San Luigi Gonzaga Torino, Italy, 10043 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma, Italy, 00168 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations A.O.U.I. Verona Verona, Italy, 37134 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations A.O.U. di Modena - Policlinico Modena, Italy, 41124 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations AUSL Modena Modena, Italy, 41012 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kantonsspital Graubünden Chur, Switzerland, 7000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Universitätsspital Basel Basel, Switzerland, 4031 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Prince of Wales Hospital Hong Kong Shatin, Hong Kong, China | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Universitätsklinikum AKH Wien Wien, Austria, 1090 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Krankenhaus der Barmherzigen Brüder Wien, Austria, 1020 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Klinik Ottakring - Wilhelminenspital Wien, Austria, 1160 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Landesklinikum Krems Krems, Austria, 3500 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Taipei Veterans General Hospital Taipei, Taiwan, China, 11217 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Chang Gung Memorial Hospital at Linkou Taoyuan, Taiwan, China, 33305 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations National Cheng Kung University Hospital Tainan, Taiwan, China, 704 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Taichung Veterans General Hospital Taichung, Taiwan, China, 40705 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations National Taiwan University Hospital Taipei, Taiwan, China, 10002 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations National University Hospital Singapore, Singapore, 119074 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations National Cancer Center Singapore Singapore, Singapore, 169610 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hopital Jean Minjoz BESANCON, France, 25030 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Cochin - Paris PARIS, France, 75674 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Centre Oscar Lambret - Lille LILLE CEDEX, France, 59020 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Centre Léon Bérard LYON CEDEX, France, 69008 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Centre de Lutte Contre le Cancer François Baclesse CAEN CEDEX 5, France, 14076 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Institut Paoli-Calmettes - Marseille MARSEILLE, France, 13273 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Princess Margaret Hospital-University Health Network Toronto, Canada, M5G 2M9 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fakultni Thomayerova Nemocnice Praha 4 - Krc, Czech Republic, 140 59 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fakultni nemocnice Kralovske Vinohrady Praha 10, Czech Republic, 10034 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fakultni nemocnice Ostrava Ostrava, Czech Republic, 708 52 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hadassah Hebrew University Hospital Ein Kerem Jerusalem, Israel, 9112001 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Clalit Health Services Rabin Medical Center-Beilinson Campus Petah Tikva, Israel, 4941492 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Chaim Sheba Medical Center Ramat Gan, Israel, 5266202 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Meir Medical Center Kfar Saba, Israel, 4428164 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Rambam Health Corporation Haifa, Israel, 3109601 | Status Completed | 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 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Bashkir State Medical University Ufa, Russia, 450008 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Clinical Oncological Dispensary of Omsk Region Omsk, Russia, 644013 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Krasnoyarsk Regional Clinical Oncology Dispensary Krasnoyarsk, Russia, 660133 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Volga District Med Center FMBA Nizhny Novgorod, Russia, 603109 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Universitario 12 de Octubre Madrid, Spain, 28041 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Centro Hospitalar Universitario do Porto Porto, Portugal, 4099-001 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations IPO Coimbra Coimbra, Portugal, 3000-075 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations CHULN - Hospital Santa Maria Lisboa, Portugal, 1649-035 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Beatriz Angelo Loures, Portugal, 2674-514 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Rigshospitalet København, Denmark, 2100 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Herlev Hospital - Oncology Research Dept. Herlev, Denmark, 2730 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Aarhus Universitetshospital, Skejby Aarhus N, Denmark, 8200 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Institut Català d'Oncologia Hospitalet L'Hospitalet de Llobregat, Spain, 08907 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kantonsspital St. Gallen St. Gallen, Switzerland, 9007 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Docrates Klinikka Helsinki, Finland, 00180 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hôpital Saint André - Bordeaux BORDEAUX, France, 33000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Clinique Saint Anne STRASBOURG, France, 67000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hôpital d'Instruction des Armées Begin SAINT MANDE, France, 94160 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Centre Médico-Chirurgical Foch SURESNES, France, 92151 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations AMNCH Dublin, Ireland, 24 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Cork University Hospital Cork, Ireland | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Alaska Clinical Research Center, LLC Anchorage, United States, 99503 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations University of Arizona Cancer Center Tuscon, United States, 85719 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Northern Cancer Institute St Leonards, Australia, 2065 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Macquarie University Hospital Sydney, Australia, 2109 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Mid North Coast Cancer Institute Coffs Harbour, Australia, 2450 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Monash Medical Centre Clayton, Australia, 3168 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Pindara Private Hospital Benowa, Australia, 4217 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Riverina Cancer Care Centre Wagga Wagga, Australia, 2650 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Eberhard-Karls-Universität Tübingen Tübingen, Germany, 72076 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Heinrich-Heine-Universität Düsseldorf Düsseldorf, Germany, 40225 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Universitätsmedizin der Johannes Gutenberg Universität Mainz Mainz, Germany, 55131 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital CUF Infante Santo Lisboa, Portugal, 1350-070 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Södersjukhuset Stockholm, Sweden, 118 83 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Centrum Onkologii im. Prof. Franciszka Lukaszczyka Bydgoszcz, Poland, 85-796 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Uniwersytecki Szpital Kliniczny UM we Wroclawiu Wroclaw, Poland, 50-556 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Swietokrzyskie Centrum Onkologii Kielce, Poland, 25-734 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc Olsztyn, Poland, 10-357 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Przychodnia Lekarska KOMED Konin, Poland, 62-500 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Szpital Kliniczny Przemienienia Panskiego Poznan, Poland, 60-569 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Orszagos Onkologiai Intezet Budapest, Hungary, 1122 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Pecsi Tudomanyegyetem Klinikai Kozpont Pecs, Hungary, 7624 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations MH Egeszsegugyi Kozpont Budapest, Hungary, 1062 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Virginia Mason Medical Center Seattle, United States, 98101 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations UC Davis Comprehensive Cancer Center Sacramento, United States, 95817 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations UZ Gent GENT, Belgium, 9000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Clinique Saint-Pierre OTTIGNIES, Belgium, 1340 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations UZ Leuven Gasthuisberg LEUVEN, Belgium, 3000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Royal Marsden Hospital (London) London, United Kingdom, SW3 6JJ | Status Terminated | Contact Us: E-mail: [email protected]bayer.com Phone: (+) 1-888-8422937 |
Locations University of Kansas Medical Center Westwood, United States, 66205 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Houston Methodist Hospital Houston, United States, 77030-2707 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations University of Southern California Los Angeles, United States, 90033 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Sapporo Medical University Hospital Sapporo, Japan, 060-8543 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hirosaki University Hospital Hirosaki, Japan, 036-8563 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Iwate Medical University Hospital Morioka, Japan, 028-3695 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Niigata University Medical and Dental Hospital Niigata, Japan, 951-8520 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations University of Tsukuba Hospital Tsukuba, Japan, 305-8576 | Status Completed | Contact Us: E-mail: clinical-tri[email protected] Phone: (+) 1-888-8422937 |
Locations The Cancer Institute Hospital of JFCR Koto-ku, Japan, 135-8550 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Nagoya University Hospital Nagoya, Japan, 466-8560 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Osaka International Cancer Institute Osaka, Japan, 541-8567 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kindai University Hospital Osakasayama, Japan, 589-8511 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hiroshima City Hiroshima Citizens Hospital Hiroshima, Japan, 730-8518 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kyushu University Hospital Fukuoka, Japan, 812-8582 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hokkaido University Hospital Sapporo, Japan, 060-8648 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Gunma Prefectural Cancer Center Ota, Japan, 373-8550 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Saitama Medical University International Medical Center Hidaka, Japan, 350-1298 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Keio University Hospital Shinjuku-ku, Japan, 160-8582 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations National Cancer Center Hospital Chuo-ku, Japan, 104-0045 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Nippon Medical School Hospital Bunkyo-ku, Japan, 113-8603 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Yokohama City University Hospital Yokohama, Japan, 236-0004 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Toyama University Hospital Toyama, Japan, 930-0194 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kobe City Medical Center General Hospital Kobe, Japan, 650-0047 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kumamoto University Hospital Kumamoto, Japan, 860-8556 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ottawa Hospital-General Campus Ottawa, Canada, K1H 8L6 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Sydney Adventist Hospital Wahroonga, Australia, 2076 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Erasmus Medisch Centrum ROTTERDAM, Netherlands, 3075 EA | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Nederlands Kanker Instituut AMSTERDAM, Netherlands, 1066 CX | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations ASST Grande Ospedale Metropolitano Niguarda Milano, Italy, 20162 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Sir Mortimer B. Davis Jewish General Hospital Montreal, Canada, H3T 1E2 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Centre Jean Perrin CLERMONT FERRAND CEDEX 1, France, 63011 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Gunma University Hospital Maebashi, Japan, 371-8511 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Karolinska Institutet Stockholm, Sweden, 17167 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Akita University Hospital Akita, Japan, 010-8543 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Bon Secours St. Francis Hospital Greenville, United States, 29607 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Bata Hospital Zlin, Czech Republic, 762 75 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Clatterbridge Centre for Oncology Bebington, United Kingdom, CH63 4JY | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Comprehensive Cancer Centers of Nevada Las Vegas, United States, 89169 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Sansum Clinic Santa Barbara, United States, 93105 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations University of Pittsburgh Pittsburgh, United States, 15232 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fudan University Shanghai Cancer Center Shanghai, China, 200032 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Liaoning Cancer Hospital and Institute Shengyang, China, 110042 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Jiangsu Cancer Hospital Nanjing, China, 210009 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations UF Cancer Center at Orlando Health Orlando, United States, 32806 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations First Affiliated Hospital of Guangzhou Medical University Guangzhou, China | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations FuJian Medical University Union Hospital Fuzhou, China, 350001 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Huadong Hospital, Affiliated to Fudan University Shanghai, China, 200040 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fifth Medical Center, General Hospital of the Chinese People Beijing, China, 100071 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Sun Yat-sen University Cancer Center Guangzhou, China, 510060 | Status Completed | 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 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hubei Cancer Hospital Wuhan, China, 430079 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Summit Cancer Center Spokane, United States, 99208 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Rocky Mountain Cancer Centers Littleton, United States, 80120-4413 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Texas Oncology-Denton South Denton, United States, 76210 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Compass Oncology Tigard, United States, 97223 | Status Completed | 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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