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NCT03473756 · ClinicalTrials.gov registry record · Phase 1
Phase 1b/2 Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab in Urothelial Carcinoma
A Phase 1 study of Urothelial Carcinoma, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
- 20
- Study locations
NCT03473756 is a Phase 1 study of Urothelial Carcinoma that has completed, run by Bayer. The registered enrollment target is 37 participants, below the 239-participant average among 85 other Urothelial Carcinoma trials with a reported enrollment target (85% lower). The trial reports 20 study locations across 13 states.
The verdict
NCT03473756, a Phase 1 study of Urothelial Carcinoma, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Atezolizumab
- DRUG Rogaratinib (BAY1163877)
Study Locations (20)
Other
- Uniklinikum Salzburg - Landeskrankenhaus - Salzburg
- Universitätsklinikum AKH Wien - Vienna
- Institut Bergonie - Unicancer Nouvelle Aquitaine - Bordeaux
- Centre Oscar Lambret - Lille - Lille
- Institut de Cancérologie de l'Ouest - Saint Herblain - Saint-Herblain
North Rhine-Westphalia
- Universitätsklinikum Köln - Cologne
- Universitätsklinikum Essen - Essen
Lombardy
- Fondazione IRCCS Istituto Nazionale dei Tumori - Milan
- Istituto Europeo di Oncologia s.r.l - Sviluppo di nuovi farmaci per Terapie Innovative - Milan
Veneto
- Istituto Oncologico Veneto - Padua
- A.O.U.I. Verona - Verona
Arizona
- University of Arizona Cancer Center - Tucson
Illinois
- UChicago Medicine Comprehensive Cancer Center - Hyde Park - Chicago
Michigan
- Barbara Ann Karmanos Cancer Institute - Detroit Headquarters - Detroit
New York
- Memorial Sloan-Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2018-05-15 |
| Est. Completion | 2024-07-10 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03473756
The ClinicalTrials.gov registry entry for NCT03473756 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 239-participant average among 85 other Urothelial Carcinoma trials with a reported enrollment target (85% lower). The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Urothelial Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Atezolizumab is the first listed.
NCT03473756 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Other, North Rhine-Westphalia, Lombardy.
Frequently Asked Questions
What is clinical trial NCT03473756 about?
NCT03473756 is a clinical study titled "Phase 1b/2 Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab in Urothelial Carcinoma". 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, obj...
What is the current status of trial NCT03473756?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2018-05-15. Estimated completion is 2024-07-10.
What conditions does trial NCT03473756 study?
This clinical trial studies the following conditions: Urothelial Carcinoma.
What interventions are being tested in trial NCT03473756?
The interventions under investigation include: Atezolizumab (DRUG), Rogaratinib (BAY1163877) (DRUG).
Who is sponsoring clinical trial NCT03473756?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03473756 being conducted?
This trial has 20 study locations across Arizona, Illinois, Michigan, New York, Upper Austria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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