Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04045613
The ClinicalTrials.gov registry entry for NCT04045613 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 238-participant average among 85 other Urothelial Carcinoma trials with a reported enrollment target (60% lower). The listed sponsor is Basilea Pharmaceutica, which has 21 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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.
Learn More About Clinical Trials
Similar trials for Urothelial Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Phase 1 Trial of ZM008 as Single Agent and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
RECRUITING · Phase 1
-
Safety, PK and Efficacy of QXL138AM in Patients With Solid Tumors and Multiple Myeloma
RECRUITING · Phase 1
-
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
RECRUITING · Phase 1
-
A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors
RECRUITING · Phase 1
-
Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors
RECRUITING · Phase 1
-
Study to Evaluate LB-LR1109, Administered Alone for the Treatment of Solid Tumor and in Combination With Atezolizumab for the Treatment of NSCLC
RECRUITING · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.