Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03410693
Other study ID # 17403
Secondary ID 2016-004340-11
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date May 31, 2018
Est. completion date October 27, 2020

Study information

Verified date September 2022
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 175
Est. completion date October 27, 2020
Est. primary completion date October 27, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Rogaratinib (BAY1163877)
Rogaratinib administered as oral (p.o.) tablets twice daily (b.i.d.) continuously
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.

Locations

Country Name City State
Australia Pindara Private Hospital Benowa Queensland
Australia Monash Medical Centre Clayton Victoria
Australia Mid North Coast Cancer Institute Coffs Harbour New South Wales
Australia Northern Cancer Institute St Leonards New South Wales
Australia Macquarie University Hospital Sydney New South Wales
Australia Riverina Cancer Care Centre Wagga Wagga New South Wales
Australia Sydney Adventist Hospital Wahroonga New South Wales
Austria Landesklinikum Krems Krems
Austria Klinik Ottakring - Wilhelminenspital Wien
Austria Krankenhaus der Barmherzigen Brüder Wien
Austria Universitätsklinikum AKH Wien Wien
Belgium UZ Gent Gent
Belgium UZ Leuven Gasthuisberg Leuven
Belgium Clinique Saint-Pierre Ottignies
Canada Sir Mortimer B. Davis Jewish General Hospital Montreal Quebec
Canada Ottawa Hospital-General Campus Ottawa
Canada Princess Margaret Hospital-University Health Network Toronto Ontario
China Fifth Medical Center, General Hospital of the Chinese People Beijing
China FuJian Medical University Union Hospital Fuzhou Fujian
China First Affiliated Hospital of Guangzhou Medical University Guangzhou
China Sun Yat-sen University Cancer Center Guangzhou Guangdong
China Jiangsu Cancer Hospital Nanjing Jiangsu
China NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School Nanjing Jiangsu
China Fudan University Shanghai Cancer Center Shanghai
China Huadong Hospital, Affiliated to Fudan University Shanghai
China Liaoning Cancer Hospital and Institute Shengyang Liaoning
China Hubei Cancer Hospital Wuhan Hubei
Czechia Fakultni nemocnice Ostrava Ostrava
Czechia Fakultni nemocnice Kralovske Vinohrady Praha 10
Czechia Fakultni Thomayerova Nemocnice Praha 4 - Krc
Czechia Bata Hospital Zlin
Denmark Aarhus Universitetshospital, Skejby Aarhus N
Denmark Herlev Hospital - Oncology Research Dept. Herlev
Denmark Rigshospitalet København
Finland Docrates Klinikka Helsinki
France Hopital Jean Minjoz Besancon
France Hôpital Saint André - Bordeaux Bordeaux
France Centre de Lutte Contre le Cancer François Baclesse Caen Cedex 5
France Centre Jean Perrin Clermont Ferrand Cedex 1
France Centre Oscar Lambret - Lille Lille Cedex
France Centre Léon Bérard Lyon Cedex
France Institut Paoli-Calmettes - Marseille Marseille
France Cochin - Paris Paris
France Hôpital d'Instruction des Armées Begin Saint Mande
France Clinique Saint Anne Strasbourg
France Centre Médico-Chirurgical Foch Suresnes
Germany Heinrich-Heine-Universität Düsseldorf Düsseldorf Nordrhein-Westfalen
Germany Universitätsmedizin der Johannes Gutenberg Universität Mainz Mainz Rheinland-Pfalz
Germany Eberhard-Karls-Universität Tübingen Tübingen Baden-Württemberg
Hong Kong Prince of Wales Hospital Hong Kong Shatin
Hungary MH Egeszsegugyi Kozpont Budapest
Hungary Orszagos Onkologiai Intezet Budapest
Hungary Pecsi Tudomanyegyetem Klinikai Kozpont Pecs
Ireland Cork University Hospital Cork
Ireland AMNCH Dublin
Israel Rambam Health Corporation Haifa
Israel Hadassah Hebrew University Hospital Ein Kerem Jerusalem
Israel Meir Medical Center Kfar Saba
Israel Clalit Health Services Rabin Medical Center-Beilinson Campus Petah Tikva
Israel Chaim Sheba Medical Center Ramat Gan
Italy IRST Istituto Scientifico Romagnolo per studio e cura tumori Forlì Cesena Emilia-Romagna
Italy ASST Grande Ospedale Metropolitano Niguarda Milano Lombardia
Italy Fondazione IRCCS Istituto Nazionale dei Tumori Milano Lombardia
Italy IRCCS Istituto Europeo di Oncologia s.r.l. (IEO) Milano Lombardia
Italy A.O.U. di Modena - Policlinico Modena Emilia-Romagna
Italy AUSL Modena Modena Emilia-Romagna
Italy A.O.U. Pisana Pisa Toscana
Italy A.O. San Camillo-Forlanini Roma Lazio
Italy Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma Lazio
Italy A.O.U. San Luigi Gonzaga Torino Piemonte
Italy A.O.U.I. Verona Verona Veneto
Japan Akita University Hospital Akita
Japan Nippon Medical School Hospital Bunkyo-ku Tokyo
Japan National Cancer Center Hospital Chuo-ku Tokyo
Japan Kyushu University Hospital Fukuoka
Japan Saitama Medical University International Medical Center Hidaka Saitama
Japan Hirosaki University Hospital Hirosaki Aomori
Japan Hiroshima City Hiroshima Citizens Hospital Hiroshima
Japan Kobe City Medical Center General Hospital Kobe Hyogo
Japan The Cancer Institute Hospital of JFCR Koto-ku Tokyo
Japan Kumamoto University Hospital Kumamoto
Japan Gunma University Hospital Maebashi Gunma
Japan Iwate Medical University Hospital Morioka Iwate
Japan Nagoya University Hospital Nagoya Aichi
Japan Niigata University Medical and Dental Hospital Niigata
Japan Osaka International Cancer Institute Osaka
Japan Kindai University Hospital Osakasayama Osaka
Japan Gunma Prefectural Cancer Center Ota Gunma
Japan Hokkaido University Hospital Sapporo Hokkaido
Japan Sapporo Medical University Hospital Sapporo Hokkaido
Japan Keio University Hospital Shinjuku-ku Tokyo
Japan Toyama University Hospital Toyama
Japan University of Tsukuba Hospital Tsukuba Ibaraki
Japan Yokohama City University Hospital Yokohama Kanagawa
Korea, Republic of National Cancer Center Goyang-si Gyeonggido
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul
Netherlands Nederlands Kanker Instituut Amsterdam
Netherlands Erasmus Medisch Centrum Rotterdam
Poland Centrum Onkologii im. Prof. Franciszka Lukaszczyka Bydgoszcz
Poland Swietokrzyskie Centrum Onkologii Kielce
Poland Przychodnia Lekarska KOMED Konin
Poland Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc Olsztyn
Poland Szpital Kliniczny Przemienienia Panskiego Poznan
Poland Uniwersytecki Szpital Kliniczny UM we Wroclawiu Wroclaw
Portugal IPO Coimbra Coimbra
Portugal CHULN - Hospital Santa Maria Lisboa
Portugal Hospital CUF Infante Santo Lisboa
Portugal Hospital Beatriz Angelo Loures Lisboa
Portugal Centro Hospitalar Universitario do Porto Porto
Russian Federation Krasnoyarsk Regional Clinical Oncology Dispensary Krasnoyarsk
Russian Federation Moscow Scient. Res. Institute of Oncology n.a P.A. Hertzen Moscow
Russian Federation Volga District Med Center FMBA Nizhny Novgorod
Russian Federation Clinical Oncological Dispensary of Omsk Region Omsk
Russian Federation Bashkir State Medical University Ufa
Singapore National Cancer Center Singapore Singapore
Singapore National University Hospital Singapore
Slovakia Narodny onkologicky ustav Bratislava
Slovakia UROEXAM, spol. s r.o. Nitra
Slovakia POKO Poprad s.r.o. Poprad
Spain Institut Català d'Oncologia Badalona Badalona Barcelona
Spain Ciutat Sanitària i Universitaria de la Vall d'Hebron Barcelona
Spain Hospital del Mar Barcelona
Spain Hospital San Pedro de Alcántara Cáceres
Spain Hospital Reina Sofía Córdoba
Spain Institut Català d'Oncologia Hospitalet L'Hospitalet de Llobregat Barcelona
Spain Hospital Ramón y Cajal Madrid
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Virgen de la Victoria Málaga
Spain Hospital Universitari Son Espases Palma de Mallorca Illes Baleares
Spain Hospital General Universitario de Valencia Valencia
Spain Instituto Valenciano de Oncología Valencia
Sweden Karolinska Institutet Stockholm
Sweden Södersjukhuset Stockholm
Switzerland Universitätsspital Basel Basel Basel-Stadt
Switzerland Kantonsspital Graubünden Chur Graubünden
Switzerland Kantonsspital St. Gallen St. Gallen Sankt Gallen
Taiwan Taichung Veterans General Hospital Taichung
Taiwan National Cheng Kung University Hospital Tainan
Taiwan National Taiwan University Hospital Taipei
Taiwan Taipei Veterans General Hospital Taipei
Taiwan Chang Gung Memorial Hospital at Linkou Taoyuan
United Kingdom Clatterbridge Centre for Oncology Bebington Merseyside
United Kingdom Royal Marsden Hospital (London) London
United States Alaska Clinical Research Center, LLC Anchorage Alaska
United States Texas Oncology-Denton South Denton Texas
United States Bon Secours St. Francis Hospital Greenville South Carolina
United States Houston Methodist Hospital Houston Texas
United States Comprehensive Cancer Centers of Nevada Las Vegas Nevada
United States Rocky Mountain Cancer Centers Littleton Colorado
United States University of Southern California Los Angeles California
United States UF Cancer Center at Orlando Health Orlando Florida
United States University of Pittsburgh Pittsburgh Pennsylvania
United States UC Davis Comprehensive Cancer Center Sacramento California
United States Sansum Clinic Santa Barbara California
United States Virginia Mason Medical Center Seattle Washington
United States Summit Cancer Center Spokane Washington
United States Compass Oncology Tigard Oregon
United States University of Arizona Cancer Center Tucson Arizona
United States University of Kansas Medical Center Westwood Kansas

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  China,  Czechia,  Denmark,  Finland,  France,  Germany,  Hong Kong,  Hungary,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Poland,  Portugal,  Russian Federation,  Singapore,  Slovakia,  Spain,  Sweden,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
See also
  Status Clinical Trial Phase
Recruiting NCT01215877 - Tesetaxel for Previously Treated Patients With Bladder Cancer Phase 2
Completed NCT03219333 - A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer Phase 2
Terminated NCT02450331 - A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection Phase 3
Active, not recruiting NCT03288545 - A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer Phase 1/Phase 2
Completed NCT01478685 - A Phase 1 Study of CC-486 as a Single Agent and in Combination With Carboplatin or ABI-007 in Subjects With Relapsed or Refractory Solid Tumors Phase 1
Completed NCT00077688 - TOCOSOL(TM) Paclitaxel in Metastatic or Locally Advanced Unresectable Transitional Cell Carcinoma of the Urothelium Phase 2
Recruiting NCT05874921 - uTRACT Jelmyto Registry: A Registry of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto
Completed NCT02451423 - Neoadjuvant Atezolizumab in Localized Bladder Cancer Phase 2
Completed NCT00001381 - A Phase I Trial Using Suramin to Treat Superficial Transitional Cell Carcinoma of the Bladder Phase 1
Recruiting NCT05318339 - A Study of Trastuzumab and Pyrotinib in HER2 Positive Locally Advanced or Metastatic Urothelial Carcinoma Phase 2
Completed NCT02443324 - A Study of Ramucirumab Plus Pembrolizumab in Participants With Gastric or GEJ Adenocarcinoma, NSCLC, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer Phase 1
Completed NCT00722553 - Study of Pralatrexate to Treat Advanced or Metastatic Relapsed Transitional Cell Carcinoma of the Urinary Bladder Phase 2
Recruiting NCT00146276 - Adjuvant Versus Progression-Triggered Gemcitabine Monotherapy for Locally Advanced Bladder Cancer Phase 3
Completed NCT02014337 - Mifepristone and Eribulin in Patients With Metastatic Triple Negative Breast Cancer or Other Specified Solid Tumors Phase 1
Recruiting NCT01189838 - The Expression and Effect of Cyr61 in Urinary Tract Transitional Cell Carcinoma N/A
Withdrawn NCT00172367 - Chemoprevention Trial for Uremia-Associated Urothelial Carcinoma Phase 2
Completed NCT00191971 - 2nd Line Gemcitabine Monotherapy for Transitional Cell Carcinoma of Urothelium (TCC) After CDDP Regimen Phase 2
Terminated NCT00127595 - Oxaliplatin With Gemcitabine in Patients With Carcinoma of the Urothelial Tract Phase 2
Terminated NCT04039867 - Evaluation of Oxaliplatin and Gemcitabine in Patients With Metastatic Bladder Cancer Phase 2
Completed NCT01529411 - Clinical Trial With Vinflunine as Maintenance Therapy in Metastatic Urothelial Cancer Phase 2