Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

FIDES-02 : An Open-label Multi-cohort Phase 1b/2 Study of Derazantinib and Atezolizumab in Patients With Urothelial Cancer Expressing Activating Molecular FGFR Aberrations

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

One/TwoPhase One/Two

18+Age Over 18

Urinary System<br/>CancersCancer LocationUrinary System
Cancers

Systemic therapy | Urinary systemUrothelial

Trial Overview Read MoreRead more

This Phase I/II trial is evaluating the efficacy of targeted therapy (derazantinib) alone, or in combination with immunotherapy (atezolizumab) in people with advanced bladder (urothelial) cancer.
 

This trial is treating patients with urothelial cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

An Open-label Multi-cohort Phase 1b/2 Study of Derazantinib and Atezolizumab in Patients With Urothelial Cancer Expressing Activating Molecular FGFR Aberrations

Commercial Sponsor

Basilea Pharmaceutica

Summary

This randomised, open-label trial consists of five sub-studies in patients with advanced urotheial cancer harbouring FGFR genetic aberrations of various clinical stages of disease progression and prior treatments. The trial has five experimental arms, also called substudies. In Substudy 1, participants with urothelial cancer who have progressed on at least one line of standard treatment will be treated with derazantinib monotherapy, at dose level one (orally, 300mg once per day). In Substudy 2, participants with solid tumours will receive derazantinib + atezolizumab. Derazantinib will be administered orally at various dose levels, atezolizumab will be administered at 1200mg every three weeks. In Substudy 3, participants with urothelial cancer will be treated with derazantinib and atezolizumab. Derazantinib will be administered orally at a dose of 200 mg twice daily in combination with atezolizumab 1200 mg every three weeks. In Substudy 4, participants with urothelial cancer progressing after prior FGFR inhibitor treatment will be randomised to receive either derazantinib alone or a combination of derazantinib and atezolizumab. Derazantinib will be administered orally (300mg, once per day), and atezolizumab will be administered as 1200mg every three weeks. In Substudy 5, participants with urothelial cancer who have progressed on at least one line of standard treatment will be treated with derazantinib monotherapy at a dose of 200mg twice daily, taken orally.

Recruiting Hospitals Read MoreRead more

Ballarat Oncology & Haematology
Ballarat
Ms Rosemary Cotton
rosemaryc@ballaratoncology.com.au
03 5339 8000

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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