Spots Global Cancer Trial Database for Phase 1b/2 Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab in Urothelial Carcinoma
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Trial Identification
Brief Title: Phase 1b/2 Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab in Urothelial Carcinoma
Official Title: An International, Multicenter, Phase 1b/2 Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab as First-line Treatment in Cisplatin-ineligible Patients With FGFR-positive Locally Advanced or Metastatic Urothelial Carcinoma
Study ID: NCT03473756
Conditions
Study Description
Brief Summary: FORT-2 is designed to evaluate safety, efficacy, RP2D and PK of rogaratinib in combination with atezolizumab in patients with untreated FGFR-positive urothelial carcinoma. The study originally comprised two separate parts: Phase 1b (Part A) and Phase 2 (Part B). The study parts differ in design, objectives, and treatment. The primary objectives of this Phase 1b study (Part A) are to determine the safety, tolerability, RP2D and pharmacokinetics of rogaratinib in combination with atezolizumab in these patients. The primary objective of the Part B is to compare progression-free survival (PFS) according to RECIST v1.1 of rogaratinib in combination with atezolizumab over placebo in combination with atezolizumab in untreated patients with FGFR-positive locally advanced or metastatic urothelial carcinoma. Of note, patients who participate in Part A are not allowed to participate in Part B. Part B will be initiated once the data from Part A supports continuation of the study, even if this occurs prior to primary completion of Part A. The sponsor may decide not to continue the study as a whole after completion of Part A if the data do not support further development. Part B of the study will no longer be conducted.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Arizona Cancer Center, Tucson, Arizona, United States
Comprehensive Cancer Center, Chicago, Illinois, United States
Barbara Ann Karmanos Cancer Institute - Detroit, Detroit, Michigan, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Ordensklinikum Linz GmbH Elisabethinen, Linz, Oberösterreich, Austria
Uniklinikum Salzburg - Landeskrankenhaus, Salzburg, , Austria
Krankenhaus der Barmherzigen Brüder, Wien, , Austria
Universitätsklinikum AKH Wien, Wien, , Austria
Institut Bergonié - Unicancer Nouvelle Aquitaine, Bordeaux Cedex, , France
Centre Oscar Lambret - Lille, Lille Cedex, , France
Institut de Cancérologie de l'Ouest - Saint Herblain, Nantes, , France
Universitätsklinikum Essen, Essen, Nordrhein-Westfalen, Germany
Universitätsklinikum Köln, Köln, Nordrhein-Westfalen, Germany
Universitätsmedizin der Johannes Gutenberg Universität Mainz, Mainz, Rheinland-Pfalz, Germany
A.O.U. di Modena - Policlinico, Modena, Emilia-Romagna, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Lombardia, Italy
IRCCS Istituto Europeo di Oncologia s.r.l. (IEO), Milano, Lombardia, Italy
Istituto Oncologico Veneto IRCCS (IOV), Padova, Veneto, Italy
A.O.U.I. Verona, Verona, Veneto, Italy
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
National Hospital Organization Shikoku Cancer Center, Matsuyama, Ehime, Japan
University of Tsukuba Hospital, Tsukuba, Ibaraki, Japan
The Cancer Institute Hospital of JFCR, Koto-ku, Tokyo, Japan
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Ciutat Sanitaria i Universitaria de la Vall d'Hebron, Barcelona, , Spain
Hospital Clínic i Provincial de Barcelona, Barcelona, , Spain
Hospital Ramón y Cajal | Oncología, Madrid, , Spain
Hospital General Universitario de Valencia, Valencia, , Spain
Contact Details
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