Bladder Cancer Clinical Trial

Derazantinib and Atezolizumab in Patients With Urothelial Cancer

Summary

The purpose of this study is 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.

View Full Description

Full Description

The study comprises five open-label substudies in patients with advanced urothelial cancer harboring FGFR GA who will be treated by derazantinib monotherapy or derazantinib in combination with atezolizumab. The study enrolls patients with cisplatin-ineligible status, or patients whose disease progressed after either first-line treatment or prior treatment with FGFR inhibitors.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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)
Measurable disease per RECIST 1.1
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
Adequate bone marrow, liver and renal function

Exclusion Criteria:

Receipt of chemotherapy, targeted therapies, immunotherapy, or treatment with an investigational anticancer agent within 2 weeks or at least 5 half-lives of the drug whichever is longer before the first dose of study drug.
Concurrent evidence of any clinically significant corneal or retinal disorder
Phosphatemia greater than institutional upper limit of normal (ULN) at screening
Uncontrolled tumor-related hypercalcemia

Study is for people with:

Bladder Cancer

Phase:

Phase 1

Estimated Enrollment:

95

Study ID:

NCT04045613

Recruitment Status:

Completed

Sponsor:

Basilea Pharmaceutica

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 66 Locations for this study

See Locations Near You

CTCA Clinical Research Inc., Atlanta
Newnan Georgia, 30265, United States
Englander Institute Weill Cornell Medicine
New York New York, 10021, United States
New York Cancer and Blood Specialists
Port Jefferson Station New York, 11776, United States
University of Texas Southwestern Medical Center (UTSWMC)
Dallas Texas, 75390, United States
MD Anderson
Houston Texas, 77030, United States
NEXT Oncology
San Antonio Texas, 78229, United States
Medical Oncology Associates PS (dba Summit Cancer Centers)
Spokane Washington, 99208, United States
Coastal Cancer Care
Birtinya , 4575, Australia
Canberra Hospital and Health Services
Canberra , 2065, Australia
John Flynn Private Hospital
Tugun , 4224, Australia
Ballarat Oncology & Haematology Services
Wendouree , 3355, Australia
Westmead Hospital
Westmead , 2145, Australia
Medizinische Universitaet Wien - Allgemeines Krankenhaus der Stadt Wien (AKH) - Universitaetsklinik fuer Urologie
Vienna , 1090, Austria
Princess Margaret Hospital
Toronto Ontario, M5G 2, Canada
Juravinski Cancer Center
Hamilton , L8V 5, Canada
Fakultni nemocnice u sv. Anny v Brne
Brno , 61700, Czechia
Fakultni Nemocnice Olomouc
Olomouc , 77900, Czechia
Institut Bergonie
Bordeaux , 33076, France
Centre François Baclesse
Caen , 14000, France
CHU Timone / CEPCM
Marseille , 13005, France
Medical Oncology - Pitié-Salpêtrière Hopital
Paris , 75030, France
IUCT-Oncopole de Toulouse
Toulouse , 31100, France
Institut Gustave Roussy
Villejuif , 94805, France
Campus Charite Mitte
Berlin , 10117, Germany
Universitaetsklinikum Duesseldorf
Duesseldorf , 40225, Germany
University Clinic Erlangen
Erlangen , 91054, Germany
Universitaetsklinikum Magdeburg A.oe.R
Magdeburg , 39120, Germany
Studienpraxis Urologie
Nürtingen , 72622, Germany
National Institute of Oncology
Budapest , 1122, Hungary
Bacs- Kiskun Megyei Korhaz
Kecskemét , 6000, Hungary
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milano , 20122, Italy
IRCCS Ospedale San Raffaele
Milano , 20132, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano , 20133, Italy
IRCCS - Istituto Europeo di Oncologia IEO
Milano , 20141, Italy
Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
Siena , 53100, Italy
ASST Valtellina e Alto Lario - UOC Oncologia Medica Ospedale di Sondrio
Sondrio , 23100, Italy
Inje University Haeundae Paik Hospital
Busan , 48108, Korea, Republic of
Pusan National University Hospital
Busan , 49241, Korea, Republic of
Chungnam National University Hospital
Daejeon , 35105, Korea, Republic of
National Cancer Center
Goyang-si , 10408, Korea, Republic of
Gachon University Gil Medical Center
Incheon , 21565, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si , 13620, Korea, Republic of
Korea University Anam Hospital
Seoul , 02841, Korea, Republic of
Seoul National University Hospital
Seoul , 110-7, Korea, Republic of
Yonsei University Health System
Seoul , 3722, Korea, Republic of
Asan Medical Center
Seoul , 5505, Korea, Republic of
Seoul St. Marys Hospital Catholic University of Korea
Seoul , 6591, Korea, Republic of
Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego
Lublin , 20-71, Poland
Med-Polonia Sp. z o. o.
Poznań , 60-69, Poland
Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o., 04-073, Warszawa, Poland
Warszawa , 04-07, Poland
Mazowiecki Szpital Onkologiczny
Wieliszew , 05-13, Poland
Vall d Hebron Hospital
Barcelona , 08035, Spain
Hospital del Mar
Barcelona , 8003, Spain
IOB - Hospital Quiron Salud
Barcelona , 8023, Spain
ICO Hospitalet
Barcelona , 8908, Spain
Hospital Universitario HM Sanchinarro CIOCC
Madrid , 28050, Spain
Marques de Valdecilla University Hospital
Santander , 39011, Spain
Hospital Universitario Virgen Macarena
Sevilla , 14009, Spain
Hospital Universitario Virgen del Rocio
Sevilla , 41013, Spain
Kantonsspital Graubünden
Chur , 7000, Switzerland
Lausanne University Hospital
Lausanne , 1011, Switzerland
UniversitaetsSpital Zuerich
Zürich , 8091, Switzerland
Barts and The London School of Medicine and Dentistry - Barts Cancer Institute (BCI)
London , EC1M , United Kingdom
The Sarah Cannon Research Institute
London , W1G 6, United Kingdom
University College London Hospitals
London , W1T7H, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 1

Estimated Enrollment:

95

Study ID:

NCT04045613

Recruitment Status:

Completed

Sponsor:


Basilea Pharmaceutica

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.