Derazantinib and Atezolizumab in Patients With Urothelial Cancer
Completed · Phase 1/Phase 2
Conditions studied: Urothelial Carcinoma
In brief
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.
Key facts
- Study ID
- NCT04045613
- Run by
- Basilea Pharmaceutica
- People needed
- 95
- Starts
- 2019-08-02
- Expected to finish
- 2022-10-04
- Last updated by the study team
- 2023-10-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically-confirmed transitional cell carcinoma of the urothelium of the upper or lower urinary tract
- Recurrent or progressing stage IV disease, or surgically unresectable, recurrent or progressing disease
- Documented central FGFR genetic aberration (FGFR1, FGFR2, or FGFR3 mutations / short variants and rearrangements / fusions) (Note; Substudy 2 started with patients requiring an FGFR GA, but this requirement was removed from the protocol later on)
- Measurable disease, as defined by the Investigator using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
- Adequate organ functions as indicated by Screening visit local laboratory values
You may not qualify if…
- Receipt of prior cancer treatment within specific interval periods
- Concurrent evidence of any clinically significant corneal or retinal disorder
- History of clinically significant cardiac disorders
- Known CNS metastases
- Concurrent uncontrolled or active infection with human immunodeficiency virus
- Active hepatitis B or chronic hepatitis B without current antiviral therapy
- Active hepatitis C
- Active tuberculosis
- Severe bacterial, fungal, viral and/or parasitic infections on therapeutic oral or IV medication at the time of first dose of study drug administration
Where it is running
- Englander Institute Weill Cornell Medicine — New York, New York, United States
- New York Cancer and Blood Specialists — Port Jefferson Station, New York, United States
- University of Texas Southwestern Medical Center (UTSWMC) — Dallas, Texas, United States
- MD Anderson — Houston, Texas, United States
- NEXT Oncology — San Antonio, Texas, United States
- Medical Oncology Associates PS (dba Summit Cancer Centers) — Spokane, Washington, United States
- Coastal Cancer Care — Birtinya, Australia
- Canberra Hospital and Health Services — Canberra, Australia
- John Flynn Private Hospital — Tugun, Australia
- Ballarat Oncology & Haematology Services — Wendouree, Australia
- Westmead Hospital — Westmead, Australia
- Medizinische Universitaet Wien - Allgemeines Krankenhaus der Stadt Wien (AKH) - Universitaetsklinik fuer Urologie — Vienna, Austria
- Princess Margaret Hospital — Toronto, Ontario, Canada
- Juravinski Cancer Center — Hamilton, Canada
- Fakultni nemocnice u sv. Anny v Brne — Brno, Czechia
- Fakultni Nemocnice Olomouc — Olomouc, Czechia
- Institut Bergonie — Bordeaux, France
- Centre François Baclesse — Caen, France
- CHU Timone / CEPCM — Marseille, France
- Medical Oncology - Pitié-Salpêtrière Hopital — Paris, France
- IUCT-Oncopole de Toulouse — Toulouse, France
- Institut Gustave Roussy — Villejuif, France
- Campus Charite Mitte — Berlin, Germany
- Universitaetsklinikum Duesseldorf — Düsseldorf, Germany
- CTCA Clinical Research Inc., Atlanta — Newnan, Georgia, United States
Full record on ClinicalTrials.gov
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