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Derazantinib and Atezolizumab in Patients With Urothelial Cancer

NCT04045613 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2023-10-13

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Basilea Pharmaceutica

    lead INDUSTRY

Principal Investigators

  • Manuel Häckl, MD · Basilea Pharmaceutica International Ltd, Allschwil

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-02
Primary Completion
2022-10-04
Completion
2022-10-04
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Poland
  • South Korea
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04045613 on ClinicalTrials.gov