Phase 2/3 study of rogaratinib vs chemo in FGFR+ urothelial carcinoma

• Research type

  Research Study

• Full title

  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 FGFR-positive locally advanced or metastatic urothelial carcinoma who have received prior platinum-containing chemotherapy

• IRAS ID

  240503

• Contact name

  Vincent Khoo

• Contact email

  vincent.khoo@rmh.nhs.uk

• Sponsor organisation

  Bayer plc

• Eudract number

  2016-004340-11

• Duration of Study in the UK

  3 years, 10 months, 13 days

• Research 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 FGFR-positive 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 tumours can be randomized into the study. Archival tumour 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.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  18/LO/0651

• Date of REC Opinion

  22 May 2018

• REC opinion

  Further Information Favourable Opinion