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Checkpoint Inhibitor

Substudy 1: Derazantinib 300 mg once daily for Bladder Cancer (FIDES-02 Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by Basilea Pharmaceutica
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose up to 2 years
Awards & highlights

FIDES-02 Trial Summary

This trial is testing derazantinib, either alone or with atezolizumab, in patients with advanced urothelial cancer that has progressed despite prior treatment and who have genetic alterations in the FGFR gene.

Eligible Conditions
  • Bladder Cancer

FIDES-02 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Patients With Dose-limiting Toxicities (DLTs) in Substudy 2
Objective Response Rate (ORR) Based on RECIST 1.1 (Substudies 1,3,4 and 5)
Recommended Phase 2 Dose (RP2D) of Derazantinib-atezolizumab in Combination Based on DLT Criteria, Safety and Efficacy Data (Substudy 2)
Secondary outcome measures
Disease Control Rate (DCR) Per RECIST 1.1 in All Substudies
Duration of Response (DOR) Per RECIST 1.1
Number of Patients With at Least Grade 3 Adverse Events (AEs)
+3 more

FIDES-02 Trial Design

7Treatment groups
Experimental Treatment
Group I: Substudy 5: Derazantinib 200 mg twice dailyExperimental Treatment1 Intervention
Patients with urothelial cancer were treated with derazantinib 200 mg twice daily
Group II: Substudy 4 (Cohort 4b):Derazantinib 300 mg once daily + atezolizumab 1200 mgExperimental Treatment1 Intervention
Patients with urothelial cancer were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Group III: Substudy 4 (Cohort 4a):Derazantinib 300 mg once dailyExperimental Treatment1 Intervention
Patients with FGFR inhibitor resistant urothelial cancer were treated with derazantinib 300 mg once daily
Group IV: Substudy 3: Derazantinib 200 mg twice daily + atezolizumab 1200 mgExperimental Treatment1 Intervention
Patients with urothelial cancer were treated with derazantinib 200 mg twice daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Group V: Substudy 2 (Dose-Level 2): Derazantinib 300 mg once daily + atezolizumab 1200 mgExperimental Treatment1 Intervention
Patients with any solid tumors were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Group VI: Substudy 2 (Dose-Level 1): Derazantinib 200 mg once daily + atezolizumab 1200 mgExperimental Treatment1 Intervention
Patients with any solid tumors were treated with derazantinib 200 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as intravenous (IV) infusion
Group VII: Substudy 1: Derazantinib 300 mg once dailyExperimental Treatment1 Intervention
Patients with urothelial cancer were treated with derazantinib 300 mg once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Derazantinib 300 mg once daily + atezolizumab 1200 mg
2019
Completed Phase 2
~100
Derazantinib 300 mg once daily monotherapy
2019
Completed Phase 2
~100
Derazantinib 300 mg once daily monotherapy (QD)
2019
Completed Phase 2
~100
Derazantinib 200 mg twice daily monotherapy
2019
Completed Phase 2
~100
Derazantinib 200 mg once daily + atezolizumab 1200 mg
2019
Completed Phase 2
~100
Derazantinib 300 mg once daily+ atezolizumab 1200 mg
2019
Completed Phase 2
~100
Derazantinib 200 mg twice daily + atezolizumab 1200 mg
2019
Completed Phase 2
~100

Find a Location

Who is running the clinical trial?

Basilea PharmaceuticaLead Sponsor
40 Previous Clinical Trials
8,980 Total Patients Enrolled
Manuel Häckl, MDStudy DirectorBasilea Pharmaceutica International Ltd, Allschwil
3 Previous Clinical Trials
195 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Derazantinib and Atezolizumab in Patients With Urothelial Cancer
2019. "Derazantinib and Atezolizumab in Patients With Urothelial Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04045613.
~17 spots leftby Apr 2025
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