CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 95 enrolled
Drug / intervention
Derazantinib 300 mg once daily monotherapy +6 moredrug
Likely dose
Derazantinib 300 mg once daily monotherapyfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04045613
NCT04045613Phase 2Completed

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

Basilea Pharmaceutica·interventional·Posted Aug 5, 2019·Updated Oct 13, 2023

In Brief

A Phase 2 clinical trial evaluating Derazantinib 300 mg once daily monotherapy, Derazantinib 200 mg once daily + atezolizumab 1200 mg, and 5 other interventions for Urothelial Carcinoma. Completed, enrolled 95 participants across 66 sites in 14 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Austria, Canada, Czechia, France, Germany, Hungary, Italy, Poland, South Korea, Spain, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedAug 5, 2019
Enrollment StartAug 2, 2019
Primary CompletionOct 4, 2022
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 6.9 years ago

Interventions

Derazantinib 300 mg once daily monotherapydrug

Derazantinib was administered orally at a dose of 300 mg once daily

Derazantinib 200 mg once daily + atezolizumab 1200 mgdrug

Derazantinib was administered orally at a dose of 200 mg once daily in combination with atezolizumab 1200 mg every 3 weeks

Derazantinib 300 mg once daily+ atezolizumab 1200 mgdrug

Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks

Derazantinib 200 mg twice daily + atezolizumab 1200 mgdrug

Derazantinib was administered orally at a dose of 200 mg twice daily in combination with atezolizumab 1200 mg every 3 weeks

Derazantinib 300 mg once daily monotherapy (QD)drug

Derazantinib was administered orally at a dose of 300 mg once daily

Derazantinib 300 mg once daily + atezolizumab 1200 mgdrug

Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks

Derazantinib 200 mg twice daily monotherapydrug

Derazantinib was administered orally at a dose of 200 mg twice daily