Summary

for people ages 18 years and up (full criteria)
at UC Davis
study started
estimated completion:

Description

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 FGFRpositive locally advanced or metastatic urothelial carcinoma who have received Prior platinum-containing chemotherapy. The primary objective of the entire study is to compare rogaratinib (BAY1163877) with chemotherapy (docetaxel, paclitaxel or vinflunine) in terms of prolonging the Overall survival (OS) of patients with FGFR positive urothelial carcinoma. 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.

Official Title

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

Keywords

Carcinoma, Transitional Cell Urothelial carcinoma Carcinoma

Eligibility

You can join if…

Open to people ages 18 years and up

  • Existence of archival or fresh biopsy for FGFR testing
  • FGFR testing of patients will be performed at the investigators' discretion up to a max. of 90 days prior to start of screening.

Investigators should ensure all patients will be eligible in terms of disease status and lines of treatment within this timeframe.

  • Documented urothelial carcinoma (transitional cell carcinoma) including urinary bladder, renal pelvis, ureters, urethra meeting all of the following criteria
  • Histologically or cytologically confirmed (patients with mixed histologies are required to have a dominant transitional cell pattern.)
  • Locally advanced (T4b, 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 (Messenger ribonucleic acid) expression levels (RNAscope score of 3+ or 4+; measurement is part of this protocol) in archival or fresh Tumor biopsy specimen
  • 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

You CAN'T join if...

  • 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 anti-cancer treatment within 4 weeks before randomization.
  • More than two prior lines of systemic anti-cancer therapy for urothelial carcinoma
  • Ongoing or previous treatment with anti-FGFR directed therapies (e.g. receptor tyrosine kinase inhibitors including rogaratinib or FGFRspecific antibodies) or with taxanes or vinflunine
  • 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)
  • Any hemorrhage / bleeding event ≥ CTCAE v.4.03 Grade 3 within 4 weeks before randomization
  • Current diagnosis of any retinal detachment, retinal pigment epithelial detachment(RPED), serous retinopathy or retinal vein occlusion

Locations

  • UC Davis Comprehensive Cancer Center not yet accepting patients
    Sacramento, California, 95817, United States
  • Univeristy of Arizona Cancer Center not yet accepting patients
    Phoenix, Arizona, 85004, United States
  • University of Arizona Cancer Center not yet accepting patients
    Tucson, Arizona, 85724, United States
  • Virginia Mason Medical Center not yet accepting patients
    Seattle, Washington, 98101, United States
  • Oklahoma University Health Science Center not yet accepting patients
    Oklahoma City, Oklahoma, 73104, United States
  • Houston Methodist Hospital not yet accepting patients
    Houston, Texas, 77030-2707, United States
  • Prairie Lakes Cancer Center not yet accepting patients
    Watertown, South Dakota, 57201, United States
  • Bon Secours St. Francis Hospital not yet accepting patients
    Greenville, South Carolina, 29607, United States
  • Juravinski Cancer Centre not yet accepting patients
    Hamilton, Ontario, L8V 5C2, Canada
  • London Regional Cancer Program withdrawn
    London, Ontario, N6A 4L6, Canada
  • Princess Margaret Hospital-University Health Network not yet accepting patients
    Toronto, Ontario, M5G 2M9, Canada
  • Carolina Urological Research Center withdrawn
    Myrtle Beach, South Carolina, 29572, United States
  • Alaska Clinical Research Center, LLC not yet accepting patients
    Anchorage, Alaska, 99503, United States
  • Ottawa Hospital-General Campus not yet accepting patients
    Ottawa, K1H 8L6, Canada
  • NYU Langone Medical Center not yet accepting patients
    New York, New York, 10016-4576, United States
  • Memorial Sloan Kettering Cancer Center not yet accepting patients
    New York, New York, 10021, United States
  • Sir Mortimer B. Davis Jewish General Hospital not yet accepting patients
    Montreal, Quebec, H3T 1E2, Canada
  • Cork University Hospital not yet accepting patients
    Cork, Ireland
  • AMNCH not yet accepting patients
    Dublin, 24, Ireland
  • Mater Misericordiae University Hospital not yet accepting patients
    Dublin, 7, Ireland
  • Mater Private Hospital not yet accepting patients
    Dublin, 7, Ireland
  • Irmandade Santa Casa de Misericordia de Porto Alegre not yet accepting patients
    Porto Alegre, Rio Grande Do Sul, 90050 170, Brazil
  • Fundação Pio XII - Hospital de Câncer de Barretos not yet accepting patients
    Barretos, Sao Paulo, 14784400, Brazil
  • Hosp Clínicas Facult. Med. de Ribeirão Preto / USP not yet accepting patients
    Ribeirão Preto, Sao Paulo, 14048-900, Brazil
  • Hospital de Base da Fundação F M S J Rio Preto not yet accepting patients
    São José do Rio Preto, Sao Paulo, Brazil
  • Musgrove Park Hospital not yet accepting patients
    Taunton, Somerset, TA1 5DA, United Kingdom
  • The Royal Marsden Hospital not yet accepting patients
    London, SW3 6JJ, United Kingdom
  • Södersjukhuset not yet accepting patients
    Stockholm, 118 83, Sweden
  • Karolinska Institutet not yet accepting patients
    Stockholm, 17167, Sweden
  • Norrlands Universitetssjukhus, Umeå not yet accepting patients
    Umeå, 901 85, Sweden
  • Nagoya University Hospital not yet accepting patients
    Nagoya, Aichi, 466-8560, Japan
  • Hirosaki University Hospital not yet accepting patients
    Hirosaki, Aomori, 036-8563, Japan
  • National Hospital Organization Shikoku Cancer Center not yet accepting patients
    Matsuyama, Ehime, 791-0280, Japan
  • Gunma University Hospital not yet accepting patients
    Maebashi, Gunma, 371-8511, Japan
  • Gunma Prefectural Cancer Center not yet accepting patients
    Ota, Gunma, 373-8550, Japan
  • Sapporo Medical University Hospital not yet accepting patients
    Sapporo, Hokkaido, 060-8543, Japan
  • Hokkaido University Hospital not yet accepting patients
    Sapporo, Hokkaido, 060-8648, Japan
  • Kobe City Medical Center General Hospital not yet accepting patients
    Kobe, Hyogo, 650-0047, Japan
  • University of Tsukuba Hospital not yet accepting patients
    Tsukuba, Ibaraki, 305-8576, Japan
  • Iwate Medical University Hospital not yet accepting patients
    Morioka, Iwate, 020-8505, Japan
  • Yokohama City University Hospital not yet accepting patients
    Yokohama, Kanagawa, 236-0004, Japan
  • Kindai University Hospital not yet accepting patients
    Osakasayama, Osaka, 589-8511, Japan
  • Saitama Medical University International Medical Center not yet accepting patients
    Hidaka, Saitama, 350-1298, Japan
  • Nippon Medical School Hospital not yet accepting patients
    Bunkyo-ku, Tokyo, 113-8603, Japan
  • National Cancer Center Hospital not yet accepting patients
    Chuo-ku, Tokyo, 104-0045, Japan
  • The Cancer Institute Hospital of JFCR not yet accepting patients
    Koto-ku, Tokyo, 135-8550, Japan
  • Keio University Hospital not yet accepting patients
    Shinjuku-ku, Tokyo, 160-8582, Japan
  • Akita University Hospital not yet accepting patients
    Akita, 010-8543, Japan
  • Kyushu University Hospital not yet accepting patients
    Fukuoka, 812-8582, Japan
  • Hiroshima City Hiroshima Citizens Hospital not yet accepting patients
    Hiroshima, 730-8518, Japan
  • Kumamoto University Hospital not yet accepting patients
    Kumamoto, 860-8556, Japan
  • Niigata University Medical and Dental Hospital not yet accepting patients
    Niigata, 951-8520, Japan
  • Osaka International Cancer Institute not yet accepting patients
    Osaka, 541-8567, Japan
  • Tokushima University Hospital not yet accepting patients
    Tokushima, 770-8503, Japan
  • Toyama University Hospital not yet accepting patients
    Toyama, 930-0194, Japan
  • Docrates Klinikka not yet accepting patients
    Helsinki, 00180, Finland
  • Tampereen yliopistollinen sairaala, keskussairaala not yet accepting patients
    Tampere, FIN-33520, Finland
  • Krasnoyarsk Regional Clinical Oncology Dispensary not yet accepting patients
    Krasnoyarsk, 660133, Russian Federation
  • Moscow Scient. Res. Institute of Oncology n.a P.A. Hertzen not yet accepting patients
    Moscow, 125284, Russian Federation
  • Urological Center POMC not yet accepting patients
    Nizhny Novgorod, 603109, Russian Federation
  • Medical Center "Avicenna" not yet accepting patients
    Novosibirsk, 630099, Russian Federation
  • Clinical Oncological Dispensary of Omsk Region not yet accepting patients
    Omsk, 644013, Russian Federation
  • Samara Regional Clinical Oncology Dispensary not yet accepting patients
    Samara, 443031, Russian Federation
  • Bashkir State Medical University not yet accepting patients
    Ufa, 450008, Russian Federation
  • Aarhus Universitetshospital, Skejby not yet accepting patients
    Aarhus N, 8200, Denmark
  • Herlev Hospital not yet accepting patients
    Herlev, 2730, Denmark
  • H:S Rigshospitalet not yet accepting patients
    København, 2100, Denmark
  • Nederlands Kanker Instituut not yet accepting patients
    Amsterdam, 1066 CX, Netherlands
  • Universitair Medisch Centrum St. Radboud not yet accepting patients
    Nijmegen, 6525 GA, Netherlands
  • Erasmus Medisch Centrum not yet accepting patients
    Rotterdam, 3075 EA, Netherlands
  • UZ Gent not yet accepting patients
    Gent, 9000, Belgium
  • CH de Jolimont - Lobbes Site de Jolimont not yet accepting patients
    La Louviere, 7100, Belgium
  • UZ Leuven Gasthuisberg not yet accepting patients
    Leuven, 3000, Belgium
  • CHU de Liège not yet accepting patients
    Liege, 4000, Belgium
  • Clinique Saint-Pierre not yet accepting patients
    Ottignies, 1340, Belgium
  • Universitätsklinikum Freiburg not yet accepting patients
    Freiburg, Baden-Württemberg, 79106, Germany
  • Klinikum der Eberhard-Karls-Universität Tübingen not yet accepting patients
    Tübingen, Baden-Württemberg, 72076, Germany
  • Universitätsklinikum Ulm not yet accepting patients
    Ulm, Baden-Württemberg, 89075, Germany
  • Universitätsklinikum Erlangen not yet accepting patients
    Erlangen, Bayern, 91054, Germany
  • Heinrich-Heine-Universität not yet accepting patients
    Düsseldorf, Nordrhein-Westfalen, 40225, Germany
  • Universitätsklinikum Köln not yet accepting patients
    Köln, Nordrhein-Westfalen, 50937, Germany
  • Universitätsmedizin der Johannes Gutenberg Universität Mainz not yet accepting patients
    Mainz, Rheinland-Pfalz, 55131, Germany
  • Medizinische Fakultät Carl Gustav Carus not yet accepting patients
    Dresden, Sachsen, 01307, Germany
  • Vivantes Klinikum Am Urban not yet accepting patients
    Berlin, 10967, Germany
  • Medizinische Fakultät der Otto-von-Guericke Universität not yet accepting patients
    Magdeburg, 39120, Germany
  • Hospital Beatriz Angelo not yet accepting patients
    Loures, Lisboa, 2674-514, Portugal
  • Centro Hospitalar e Universitário de Coimbra not yet accepting patients
    Coimbra, 3000-075, Portugal
  • Instituto Português Oncologia - Coimbra not yet accepting patients
    Coimbra, 3000-075, Portugal
  • Hospital CUF Infante Santo not yet accepting patients
    Lisboa, 1350-070, Portugal
  • Centro Hospitalar de Lisboa Norte - Hospital Santa Maria not yet accepting patients
    Lisboa, 1649-035, Portugal
  • Centro Hospitalar do Porto, EPE not yet accepting patients
    Porto, 4099-001, Portugal
  • National Cancer Center not yet accepting patients
    Goyang-si, Gyeonggido, 410-769, Korea, Republic of
  • Yonsei University College of Medicine accepting new patients
    Seoul, 120-752, Korea, Republic of
  • Samsung Medical Center not yet accepting patients
    Seoul, 135-710, Korea, Republic of
  • Asan Medical Center not yet accepting patients
    Seoul, 138-736, Korea, Republic of
  • Hopital J. Minjoz - Besançon not yet accepting patients
    Besancon, 25030, France
  • Hôpital Saint André - Bordeaux not yet accepting patients
    Bordeaux, 33000, France
  • Centre François Baclesse - CLCC not yet accepting patients
    Caen Cedex 5, 14076, France
  • Centre Jean Perrin not yet accepting patients
    Clermont Ferrand Cedex 1, 63011, France
  • Centre Oscar Lambret - Lille not yet accepting patients
    Lille Cedex, 59020, France
  • Centre Léon Bérard not yet accepting patients
    Lyon Cedex, 69008, France
  • Institut Paoli-Calmettes - Marseille not yet accepting patients
    Marseille, 13273, France
  • Hôpital Saint Louis - Paris not yet accepting patients
    Paris, 75010, France
  • Cochin - Paris not yet accepting patients
    Paris, 75674, France
  • Hôpital d'Instruction des Armées Begin not yet accepting patients
    Saint Mande, 94160, France
  • Clinique Saint Anne - Strasbourg not yet accepting patients
    Strasbourg, 67000, France
  • Centre Médico-Chirurgical Foch not yet accepting patients
    Suresnes, 92151, France
  • Hospital Reina Sofía not yet accepting patients
    Córdoba, Andalucía, 14004, Spain
  • Institut Català d'Oncologia Badalona not yet accepting patients
    Badalona, Barcelona, 08916, Spain
  • Institut Català d'Oncologia Hospitalet not yet accepting patients
    L'Hospitalet de Llobregat, Barcelona, 08907, Spain
  • Hospital del Mar not yet accepting patients
    Barcelona, Catalunya, 08003, Spain
  • Hospital Universitari Son Espases not yet accepting patients
    Palma de Mallorca, Illes Baleares, 07120, Spain
  • Ciutat Sanitària i Universitaria de la Vall d'Hebron not yet accepting patients
    Barcelona, 08035, Spain
  • Hospital San Pedro de Alcántara not yet accepting patients
    Cáceres, 10003, Spain
  • MD Anderson International Espanya, S.A. not yet accepting patients
    Madrid, 28033, Spain
  • Hospital Ramón y Cajal not yet accepting patients
    Madrid, 28034, Spain
  • Hospital Universitario 12 de Octubre not yet accepting patients
    Madrid, 28041, Spain
  • Hospital Virgen de la Victoria not yet accepting patients
    Málaga, 29010, Spain
  • Instituto Valenciano de Oncología not yet accepting patients
    Valencia, 46009, Spain
  • Hospital General Universitario de Valencia not yet accepting patients
    Valencia, 46014, Spain
  • Universitätsspital Basel not yet accepting patients
    Basel, Basel-Stadt, 4031, Switzerland
  • Kantonsspital Graubünden not yet accepting patients
    Chur, Graubünden, 7000, Switzerland
  • Kantonsspital St. Gallen not yet accepting patients
    St. Gallen, Sankt Gallen, 9007, Switzerland
  • Inselspital Universitätsspital Bern not yet accepting patients
    Bern, 3010, Switzerland
  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka not yet accepting patients
    Bydgoszcz, 85-796, Poland
  • Swietokrzyskie Centrum Onkologii not yet accepting patients
    Kielce, 25-734, Poland
  • Przychodnia Lekarska KOMED not yet accepting patients
    Konin, 62-500, Poland
  • Salve Medica Sp. z o.o. SP.K. not yet accepting patients
    Lodz, 91-211, Poland
  • Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc not yet accepting patients
    Olsztyn, 10-357, Poland
  • SP Szpital Kliniczny nr 2 not yet accepting patients
    Poznan, 60-569, Poland
  • Uroprojekt s.c. - Gabinet urologiczny withdrawn
    Siedlce, 08-110, Poland
  • Centralny Szpital Kliniczny MSWiA w Warszawie not yet accepting patients
    Warszawa, 02-507, Poland
  • Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego not yet accepting patients
    Wroclaw, 50-556, Poland
  • Fakultni Nemocnice Olomouc not yet accepting patients
    Olomouc, 775 20, Czechia
  • Fakultni nemocnice Ostrava not yet accepting patients
    Ostrava, 708 52, Czechia
  • Fakultni nemocnice Kralovske Vinohrady not yet accepting patients
    Praha 10, 10034, Czechia
  • Fakultni Thomayerova Nemocnice not yet accepting patients
    Praha 4 - Krc, 140 59, Czechia
  • Krankenhaus der Barmherzigen Schwestern Linz not yet accepting patients
    Linz, Oberösterreich, 4010, Austria
  • Medizinische Universität Graz not yet accepting patients
    Graz, Steiermark, 8036, Austria
  • Landesklinikum Krems not yet accepting patients
    Krems, 3500, Austria
  • Krankenhaus der Barmherzigen Brüder not yet accepting patients
    Wien, 1020, Austria
  • Allgemeines Krankenhaus der Stadt Wien not yet accepting patients
    Wien, 1090, Austria
  • Wilhelminenspital der Stadt Wien not yet accepting patients
    Wien, 1160, Austria
  • Narodny onkologicky ustav not yet accepting patients
    Bratislava, 833 10, Slovakia
  • UROEXAM, spol. s r.o. not yet accepting patients
    Nitra, 949 01, Slovakia
  • POKO Poprad s.r.o. not yet accepting patients
    Poprad, 085 01, Slovakia
  • MH Egeszsegugyi Kozpont not yet accepting patients
    Budapest, 1062, Hungary
  • Semmelweis Egyetem not yet accepting patients
    Budapest, 1082, Hungary
  • Bajcsy Zsilinszky Korhaz-Rendelointezet not yet accepting patients
    Budapest, 1106, Hungary
  • Orszagos Onkologiai Intezet not yet accepting patients
    Budapest, 1122, Hungary
  • Debreceni Egyetem Klinikai Kozpont not yet accepting patients
    Debrecen, 4032, Hungary
  • Pecsi Tudomanyegyetem Klinikai Kozpont not yet accepting patients
    Pecs, 7624, Hungary
  • IRST Istituto Scientifico Romagnolo per studio e cura Tumori not yet accepting patients
    Forlì-Cesena, Emilia-Romagna, 47014, Italy
  • AUSL Modena not yet accepting patients
    Modena, Emilia-Romagna, 41012, Italy
  • A.O.U. di Modena - Policlinico not yet accepting patients
    Modena, Emilia-Romagna, 41124, Italy
  • Policlinico Universitario Campus BioMedico not yet accepting patients
    Roma, Lazio, 00128, Italy
  • A.O. San Camillo-Forlanini not yet accepting patients
    Roma, Lazio, 00152, Italy
  • Fond. Policlinico Universitario A. Gemelli not yet accepting patients
    Roma, Lazio, 00168, Italy
  • Fondazione IRCCS Istituto Nazionale dei Tumori not yet accepting patients
    Milano, Lombardia, 20133, Italy
  • IRCCS Istituto Europeo Oncologia (IEO) not yet accepting patients
    Milano, Lombardia, 20141, Italy
  • ASST Grande Ospedale Metropolitano Niguarda not yet accepting patients
    Milano, Lombardia, 20162, Italy
  • A.O.U. San Luigi Gonzaga not yet accepting patients
    Torino, Piemonte, 10043, Italy
  • A.O.U. Pisana not yet accepting patients
    Pisa, Toscana, 56126, Italy
  • A.O.U. Integrata Verona not yet accepting patients
    Verona, Veneto, 37134, Italy
  • China Medical University Hospital not yet accepting patients
    Taichung, 40447, Taiwan
  • Taichung Veterans General Hospital not yet accepting patients
    Taichung, 40705, Taiwan
  • National Cheng Kung University Hospital not yet accepting patients
    Tainan, Taiwan
  • National Taiwan University Hospital not yet accepting patients
    Taipei, 10002, Taiwan
  • Taipei Veterans General Hospital not yet accepting patients
    Taipei, 11217, Taiwan
  • Chang Gung Memorial Hospital at Linkou not yet accepting patients
    Taoyuan, 333, Taiwan
  • Queen Mary Hospital not yet accepting patients
    Hong Kong, Hong Kong
  • Princess Margaret Hospital not yet accepting patients
    Kowloon, Hong Kong
  • Queen Elizabeth Hospital not yet accepting patients
    Kowloon, Hong Kong
  • Prince of Wales Hospital not yet accepting patients
    Shatin, Hong Kong
  • Rambam Health Corporation not yet accepting patients
    Haifa, 3109601, Israel
  • Hadassah Hebrew University Hospital Ein Kerem not yet accepting patients
    Jerusalem, 9112001, Israel
  • Meir Medical Center not yet accepting patients
    Kfar Saba, 4428164, Israel
  • Rabin Medical Center - Beilinson Campus not yet accepting patients
    Petah Tikva, 4941492, Israel
  • Chaim Sheba Medical Center not yet accepting patients
    Ramat Gan, 5266202, Israel
  • Mid North Coast Cancer Institute not yet accepting patients
    Coffs Harbour, New South Wales, 2450, Australia
  • Northern Cancer Institute not yet accepting patients
    St Leonards, New South Wales, 2065, Australia
  • Riverina Cancer Care Centre not yet accepting patients
    Wagga Wagga, New South Wales, 2650, Australia
  • Sydney Adventist Hospital not yet accepting patients
    Wahroonga, New South Wales, 2076, Australia
  • Pindara Private Hospital not yet accepting patients
    Benowa, Queensland, 4217, Australia
  • Monash Cancer Centre not yet accepting patients
    East Bentleigh, Victoria, 3165, Australia
  • National University Hospital not yet accepting patients
    Singapore, 119074, Singapore
  • National Cancer Center not yet accepting patients
    Singapore, 169610, Singapore

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bayer
Links
Click here and search for drug information provided by the FDA.
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.
ID
NCT03410693
Phase
Phase 2/3
Study Type
Interventional
Last Updated
May 11, 2018