check_circleStudy Completed
Urothelial Carcinoma
Bayer Identifier:
19131
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Phase 1b/2 study of rogaratinib (BAY1163877) in combination with atezolizumab in urothelial carcinoma
Trial purpose
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.
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.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
37Trial Dates
May 2018 - July 2024Phase
Phase 1Could I Receive a placebo
NoProducts
Rogaratinib (BAY1163877)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Centre Oscar Lambret - Lille | LILLE CEDEX, 59020, France |
Completed | Institut Bergonie - Unicancer Nouvelle Aquitaine | BORDEAUX CEDEX, 33076, France |
Completed | Institut de Cancérologie de l'Ouest - Saint Herblain | Saint-Herblain, 44800, France |
Completed | Ciutat Sanitaria i Universitaria de la Vall d'Hebron | Barcelona, 08035, Spain |
Withdrawn | Hospital de la Santa Creu i de Sant Pau | Oncología | Barcelona, 8041, Spain |
Completed | Hospital General Universitario de Valencia | Valencia, 46014, Spain |
Completed | Hospital Ramón y Cajal | Oncología | Madrid, 28034, Spain |
Completed | Severance Hospital, Yonsei University Health System | Seoul, 03722, Korea,_republic_of |
Completed | Asan Medical Center | Seoul, 05505, Korea,_republic_of |
Completed | Universitätsklinikum AKH Wien | Wien, 1090, Austria |
Completed | Krankenhaus der Barmherzigen Brüder | Vienna, 1020, Austria |
Completed | Ordensklinikum Linz GmbH Elisabethinen | Linz, 4020, Austria |
Completed | Uniklinikum Salzburg - Landeskrankenhaus | Salzburg, 5020, Austria |
Completed | Fondazione IRCCS Istituto Nazionale dei Tumori | Milano, 20133, Italy |
Completed | Azienda Ospedaliero Universitaria di Modena | Modena, 41100, Italy |
Completed | Istituto Europeo di Oncologia s.r.l - Sviluppo di nuovi farmaci per Terapie Innovative | Milano, 20141, Italy |
Completed | A.O.U.I. Verona | Verona, 37134, Italy |
Completed | Istituto Oncologico Veneto | Padova, 35128, Italy |
Completed | Universitätsklinikum Essen | Essen, 45147, Germany |
Completed | Universitätsklinikum Köln | Köln, 50937, Germany |
Withdrawn | Eberhard-Karls-Universität Tübingen | Tübingen, 72076, Germany |
Completed | Universitätsmedizin der Johannes Gutenberg Universität Mainz | Mainz, 55101, Germany |
Completed | University of Arizona Cancer Center | Tucson, 85724, United States |
Withdrawn | University of California - Davis | Sacramento, 95817, United States |
Completed | Barbara Ann Karmanos Cancer Institute - Detroit Headquarters | Detroit, 48201, United States |
Completed | Memorial Sloan-Kettering Cancer Center | New York, 10065, United States |
Completed | UChicago Medicine Comprehensive Cancer Center - Hyde Park | Chicago, 60637, United States |
Completed | Samsung Medical Center | Seoul, 06351, Korea,_republic_of |
Completed | University of Tsukuba Hospital | Tsukuba, 305-8576, Japan |
Completed | The Cancer Institute Hospital of JFCR | Koto-ku, 135-8550, Japan |
Completed | National Cancer Center Hospital East | Kashiwa, 277-8577, Japan |
Completed | National Hospital Organization Shikoku Cancer Center | Matsuyama, 791-0280, Japan |
Completed | Hospital Clínic i Provincial de Barcelona | Barcelona, 8036, Spain |
Primary Outcome
- Number of participants with Dose-limiting toxicities(DLTs)date_rangeTime Frame:Up to 21 days
- Number of participants with treatment-emergent adverse events (TEAEs)date_rangeTime Frame:Up to 30 days after the last dose of rogaratinib or 90 days after the last atezolizumab administration, whichever comes later
- Number of participants with drug-related TEAEsdate_rangeTime Frame:Up to 30 days after the last dose of rogaratinib or 90 days after the last atezolizumab administration, whichever comes later
- Number of participants with treatment-emergent serious adverse events(TESAEs)date_rangeTime Frame:Up to 30 days after the last dose of rogaratinib or 90 days after the last atezolizumab administration, whichever comes later
Secondary Outcome
- Objective Response Rate(ORR)Objective response rate (ORR) was defined as the percentage of patients with complete response (CR) or partial response (PR). Patients for whom best overall tumor response was not CR or PR, as well as patients without any post-baseline tumor assessment were considered non-responders. For all patients, the best overall tumor response was determined locally by investigators using the RECIST (Response Evaluation Criteria In Solid Tumors) criteria.date_rangeTime Frame:Up to 5 months
- Maximal plasma concentration (Cmax) of rogaratinibdate_rangeTime Frame:At cycle 1 Day 1
- Area under the rogaratinib concentration versus time curve (AUC)date_rangeTime Frame:At cycle 1 Day 1, 0-t(last)
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
N/AAssignment
Single Group AssignmentTrial Arms
1