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About this trial

This is a randomized, open-label, multicenter Phase 2/3 trial 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 of the entire trial 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.

Patient Profile

Patients who have locally advanced or metastatic urothelial carcinoma who have received at least one prior platinum-containing chemotherapy regimen. Only patients with FGFR1 or 3 positive tumors can be randomized into the trial.

Where’s this trial being run?

Cork University Hospital, St James’s Hospital, and Tallaght University Hospital

Can I join this study / trial?

The first thing you do is to talk to your doctor and/or the cancer trials research team in your hospital. The contact details for the cancer trials research units in Ireland is here.

Why not Print this page and bring it with you. It will help your doctor and research team advise you.

For more detailed information

Questions?

Here’s a list of questions you may have for your doctor or local cancer research team.

Summary Data

Name: 17403/ FORT-1
Number: 17-04
Full 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.

Principal Investigator: Prof Ray McDermott (Tallaght University Hospital)
Type: Industry Sponsored
Sponsor:

Bayer

Recruitment Started: Global: May 2018
Ireland: June 2018
Global Recruitment Target: 400
Ireland Recruitment Target: 13