The purpose of this study is to evaluate efficacy of derazantinib single-agent 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.
The study comprises four open-label substudies in patients with advanced urothelial cancer
harboring FGFR GA who will be treated by single-agent derazantinib 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.
Overal Status | Start Date | Phase | Study Type |
---|---|---|---|
Recruiting | July 25, 2019 | Phase 1/Phase 2 | Interventional |
Primary Outcome 1 - Measure: Overall Response Rate (ORR) based on RECIST 1.1
Primary Outcome 1 - Time Frame: Approximately up to 2 years
Primary Outcome 2 - Measure: Recommended Phase 2 dose (RP2D) of derazantinib in combination with atezolizumab
Primary Outcome 2 - Time Frame: Approximately up to 8 weeks
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 alteration
- 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
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Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Frédérique Cantero, MD
Role: Study Director
Affiliation: Basilea Pharmaceutica International Ltd
Name: Frédérique Cantero, MD
Phone: +41 76 830 2499
Email: Frederique.Cantero@basilea.com
Facility | Status | Contact |
---|---|---|
University Cancer and Blood Center Athens, Georgia 30607 United States |
Recruiting | |
CTCA Clinical Research Inc., Atlanta Newnan, Georgia 30265 United States |
Recruiting | |
Midwestern Regional Medical Center, Inc. DBA CTCA, Chicago Zion, Illinois 60099 United States |
Recruiting | |
Norton Cancer Institute, Norton Healthcare Pavilion Louisville, Kentucky 40202 United States |
Recruiting | |
New York Cancer and Blood Specialists Port Jefferson Station, New York 11776 United States |
Recruiting | |
Greenville Health System - Prisma Health Cancer Institute Greenville, South Carolina 29605 United States |
Recruiting | |
University of Texas Southwestern Medical Center (UTSWMC) Dallas, Texas 75390-8852 United States |
Recruiting | |
MD Anderson Houston, Texas 77030 United States |
Recruiting | |
NEXT Oncology San Antonio, Texas 78229 United States |
Recruiting | |
University of Virginia Health System Charlottesville, Virginia 22908 United States |
Recruiting | |
Medical Oncology Associates PS (dba Summit Cancer Centers) Spokane, Washington 99208 United States |
Recruiting | |
Coastal Cancer Care Birtinya, 4575 Australia |
Recruiting | |
John Flynn Private Hospital Tugun, 4224 Australia |
Recruiting | |
Ballarat Oncology & Haematology Services Wendouree, 3355 Australia |
Recruiting | |
Westmead Hospital Westmead, 2145 Australia |
Recruiting | |
Ordensklinikum Linz GmbH Elisabethinen Linz, 4020 Austria |
Recruiting | |
Krankenhaus Barmherzige Brüder Wien Vienna, 1020 Austria |
Recruiting | |
Universitair Ziekenhuis Brussel Jette, 1090 Belgium |
Recruiting | |
CHA Centre Hospitalier de l'Ardenne Libramont, 6800 Belgium |
Recruiting | |
Juravinski Cancer Center Hamilton, L8V 5C2 Canada |
Recruiting | |
Fakultni nemocnice u sv. Anny v Brne Brno, 61700 Czechia |
Recruiting | |
Fakultni Nemocnice Olomouc Olomouc, 77900 Czechia |
Recruiting | |
Nemocnice na Bulovce Prague, 18081 Czechia |
Recruiting | |
Institut Bergonie Bordeaux, 33076 CEDEX France |
Recruiting | |
Centre François Baclesse Caen, 14000 France |
Recruiting | |
CHU Timone / CEPCM Marseille, 13005 France |
Recruiting | |
Medical Oncology - Pitié-Salpêtrière Hopital Paris, 75030 France |
Recruiting | |
IUCT-Oncopole de Toulouse Toulouse, 31100 France |
Recruiting | |
Institut Gustave Roussy Villejuif, 94805 France |
Recruiting | |
Campus Charite Mitte Berlin, 10117 Germany |
Recruiting | |
Universitaetsklinikum Carl Gustav Carus Dresden, 01307 Germany |
Recruiting | |
Studienpraxis Urologie Nürtingen, 72622 Germany |
Recruiting | |
National Institute of Oncology Budapest, 1122 Hungary |
Recruiting | |
Onkolgiai Klinika Debrecen, 4032 Hungary |
Recruiting | |
Bacs- Kiskun Megyei Korhaz Kecskemét, 6000 Hungary |
Recruiting | |
B.A.Z.Megyei Központi Kórház és Egyetemi Oktató Kórház Miskolc, 3526 Hungary |
Recruiting | |
ASST Istituti Ospitalieri Cremona, 26100 Italy |
Recruiting | |
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano, 20122 Italy |
Recruiting | |
Fondazione IRCCS Istituto Nazionale dei Tumori Milano, 20133 Italy |
Recruiting | |
IRCCS - Istituto Europeo di Oncologia IEO Milano, 20141 Italy |
Recruiting | |
Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte Siena, 53100 Italy |
Recruiting | |
Inje University Haeundae Paik Hospital Busan, 48108 Korea, Republic of |
Recruiting | |
Pusan National University Hospital Busan, 49241 Korea, Republic of |
Recruiting | |
Chungnam National University Hospital Daejeon, 35105 Korea, Republic of |
Recruiting | |
National Cancer Center Goyang-si, 10408 Korea, Republic of |
Recruiting | |
Gachon University Gil Medical Center Incheon, 21565 Korea, Republic of |
Recruiting | |
Seoul National University Bundang Hospital Seongnam-si, 13620 Korea, Republic of |
Recruiting | |
Korea University Anam Hospital Seoul, 02841 Korea, Republic of |
Recruiting | |
Seoul National University Hospital Seoul, 110-744 Korea, Republic of |
Recruiting | |
Yonsei University Health System Seoul, 3722 Korea, Republic of |
Recruiting | |
Asan Medical Center Seoul, 5505 Korea, Republic of |
Recruiting | |
Seoul St. Marys Hospital Catholic University of Korea Seoul, 6591 Korea, Republic of |
Recruiting | |
Med-Polonia Sp. z o. o. Poznań, 60-693 Poland |
Recruiting | |
Mazowiecki Szpital Onkologiczny Wieliszew, 05-135 Poland |
Recruiting | |
Vall d Hebron Hospital Barcelona, 08035 Spain |
Recruiting | |
Hospital del Mar Barcelona, 8003 Spain |
Recruiting | |
IOB - Hospital Quiron Salud Barcelona, 8023 Spain |
Recruiting | |
ICO Hospitalet Barcelona, 8908 Spain |
Recruiting | |
Hospital Universitario HM Sanchinarro CIOCC Madrid, 28050 Spain |
Recruiting | |
Marques de Valdecilla University Hospital Santander, 39011 Spain |
Recruiting | |
Hospital Universitario Virgen Macarena Sevilla, 14009 Spain |
Recruiting | |
Hospital Universitario Virgen del Rocio Sevilla, 41013 Spain |
Recruiting | |
Barts and The London School of Medicine and Dentistry - Barts Cancer Institute (BCI) London, EC1M 6BQ United Kingdom |
Recruiting | |
The Sarah Cannon Research Institute London, W1G 6AD United Kingdom |
Recruiting | |
The Royal Marsden NHS Foundation Trust Sutton, SM2 5PT United Kingdom |
Recruiting |