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NCT04045613 · ClinicalTrials.gov registry record · Phase 1
Derazantinib and Atezolizumab in Patients With Urothelial Cancer
A Phase 1 study of Urothelial Carcinoma, sponsored by Basilea Pharmaceutica.
- Completed
- Registry status
- Phase 1
- Development phase
- 95
- Enrollment target
- 20
- Study locations
NCT04045613: Completed Phase 1 study of Urothelial Carcinoma, sponsored by Basilea Pharmaceutica.
NCT04045613 is a Phase 1 study of Urothelial Carcinoma that has completed, run by Basilea Pharmaceutica. The registered enrollment target is 95 participants, below the 238-participant average among 85 other Urothelial Carcinoma trials with a reported enrollment target (60% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04045613, a Phase 1 study of Urothelial Carcinoma, has completed, sponsored by Basilea Pharmaceutica.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 95 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
ORR was defined as the proportion of patients who achieved a confirmed clinical response (CR) or partial response (PR) by blinded investigator central review (BICR) using the internationally recognized criteria for the radiological assessment in tumor response of solid tumors (RECIST) Version 1.1
Conditions Studied
Interventions
- DRUG Derazantinib 300 mg once daily monotherapy
- DRUG Derazantinib 200 mg once daily + atezolizumab 1200 mg
- DRUG Derazantinib 300 mg once daily+ atezolizumab 1200 mg
- DRUG Derazantinib 200 mg twice daily + atezolizumab 1200 mg
- DRUG Derazantinib 300 mg once daily monotherapy (QD)
Study Locations (20)
Other
- Coastal Cancer Care - Birtinya
- Canberra Hospital and Health Services - Canberra
- John Flynn Private Hospital - Tugun
- Ballarat Oncology & Haematology Services - Wendouree
- Westmead Hospital - Westmead
- Medizinische Universitaet Wien - Allgemeines Krankenhaus der Stadt Wien (AKH) - Universitaetsklinik fuer Urologie - Vienna
- Juravinski Cancer Center - Hamilton
- Fakultni nemocnice u sv. Anny v Brne - Brno
- Fakultni Nemocnice Olomouc - Olomouc
- Institut Bergonie - Bordeaux
- Centre François Baclesse - Caen
- CHU Timone / CEPCM - Marseille
Texas
- University of Texas Southwestern Medical Center (UTSWMC) - Dallas
- MD Anderson - Houston
- NEXT Oncology - San Antonio
New York
- Englander Institute Weill Cornell Medicine - New York
- New York Cancer and Blood Specialists - Port Jefferson Station
Georgia
- CTCA Clinical Research Inc., Atlanta - Newnan
Washington
- Medical Oncology Associates PS (dba Summit Cancer Centers) - Spokane
Ontario
- Princess Margaret Hospital - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2019-08-02 |
| Est. Completion | 2022-10-04 |
| Phase | Phase 1 |
What the finished NCT04045613 record still lists
NCT04045613 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 238-participant average among 85 other Urothelial Carcinoma trials with a reported enrollment target (60% lower).
The record links to 1 condition, with Urothelial Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Derazantinib 300 mg once daily monotherapy is the first listed.
NCT04045613 names 20 study sites across 6 states, led by Other, Texas, New York.
Frequently Asked Questions
What is clinical trial NCT04045613 about?
NCT04045613 is a clinical study titled "Derazantinib and Atezolizumab in Patients With Urothelial Cancer". 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 pri...
What is the current status of trial NCT04045613?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 95 participants. The study started on 2019-08-02. Estimated completion is 2022-10-04.
What conditions does trial NCT04045613 study?
This clinical trial studies the following conditions: Urothelial Carcinoma.
What interventions are being tested in trial NCT04045613?
The interventions under investigation include: Derazantinib 300 mg once daily monotherapy (DRUG), Derazantinib 200 mg once daily + atezolizumab 1200 mg (DRUG), Derazantinib 300 mg once daily+ atezolizumab 1200 mg (DRUG), Derazantinib 200 mg twice daily + atezolizumab 1200 mg (DRUG), Derazantinib 300 mg once daily monotherapy (QD) (DRUG).
Who is sponsoring clinical trial NCT04045613?
This trial is sponsored by Basilea Pharmaceutica, which has 21 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04045613 being conducted?
This trial has 20 study locations across Georgia, New York, Texas, Washington, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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participants (enrollment target), bucketed by value
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