Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 1

Derazantinib and Atezolizumab in Patients With Urothelial Cancer

NCT04045613 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 95 participants
Start Date 2019-08-02
Est. Completion 2022-10-04
Phase Phase 1

Sponsor

Basilea Pharmaceutica

9 total trials

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Basilea Pharmaceutica, which has 9 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04045613 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Other, Texas, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04045613?

This trial is sponsored by Basilea Pharmaceutica, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial