NCT04045613

Derazantinib and Atezolizumab in Patients With Urothelial Cancer

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Basilea Pharmaceutica · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate efficacy of derazantinib monotherapy or derazantinib-atezolizumab in combination in patients with advanced urothelial cancer harboring fibroblast growth factor receptor (FGFR) genetic aberrations (GA) of various clinical stages of disease progression and prior treatments.

Detailed description

The study comprised five open-label substudies (1-5) in patients with advanced urothelial cancer harboring FGFR GA (with the exception of substudy 2 which did not require a FGFR GA) who were treated by derazantinib monotherapy or derazantinib in combination with atezolizumab. The study enrolled patients with cisplatin-ineligible status, or patients whose disease progressed after either first-line treatment or prior treatment with FGFR inhibitors.

Conditions

• Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	Derazantinib 300 mg once daily monotherapy	Derazantinib was administered orally at a dose of 300 mg once daily
DRUG	Derazantinib 200 mg once daily + atezolizumab 1200 mg	Derazantinib was administered orally at a dose of 200 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
DRUG	Derazantinib 300 mg once daily+ atezolizumab 1200 mg	Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
DRUG	Derazantinib 200 mg twice daily + atezolizumab 1200 mg	Derazantinib was administered orally at a dose of 200 mg twice daily in combination with atezolizumab 1200 mg every 3 weeks
DRUG	Derazantinib 300 mg once daily monotherapy (QD)	Derazantinib was administered orally at a dose of 300 mg once daily
DRUG	Derazantinib 300 mg once daily + atezolizumab 1200 mg	Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
DRUG	Derazantinib 200 mg twice daily monotherapy	Derazantinib was administered orally at a dose of 200 mg twice daily

Timeline

• Start date: 2019-08-02
• Primary completion: 2022-10-04
• Completion: 2022-10-04
• First posted: 2019-08-05
• Last updated: 2023-10-13
• Results posted: 2023-10-13

Locations

66 sites across 14 countries: United States, Australia, Austria, Canada, Czechia, France, Germany, Hungary, Italy, Poland, South Korea, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study