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An Open-label Multi-cohort Phase 1b/2 Study of Derazantinib and Atezolizumab in Patients With Urothelial Cancer Expressing Activating Molecular FGFR Aberrations
Condition: Urothelial Carcinoma
Intervention:
- Drug: Derazantinib
- Drug: Atezolizumab (drug supplied by Hoffmann-La Roche)
Purpose: 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.
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT04045613
Sponsor: Basilea Pharmaceutica
Primary Outcome Measures:
- Measure: Overall Response Rate (ORR) based on RECIST 1.1
- Time Frame: Approximately up to 2 years
- Safety Issue:
- Measure: Recommended Phase 2 dose (RP2D) of derazantinib in combination with atezolizumab
- Time Frame: Approximately up to 8 weeks
- Safety Issue:
Secondary Outcome Measures:
- Measure: Disease control rate per RECIST 1.1
- Time Frame: Approximately up to 2 years
- Safety Issue:
- Measure: Duration of Response per RECIST 1.1
- Time Frame: Approximately up to 2 years
- Safety Issue:
- Measure: Median progression-free survival (PFS) and PFS at 6 months
- Time Frame: Approximately up to 2 years
- Safety Issue:
- Measure: Median overall survival (OS) and OS at 6 months
- Time Frame: Approximately up to 2 years
- Safety Issue:
- Measure: Safety and tolerability of study treatment based on incidence of treatment-emergent adverse events
- Time Frame: Approximately up to 2 years
- Safety Issue:
Estimated Enrollment: 303
Study Start Date: July 25, 2019
Phase: Phase 1/Phase 2
Eligibility:
- Age: minimum 18 Years maximum N/A
- Gender: All
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 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 corneal or retinal disorder
- Phosphatemia greater than institutional upper limit of normal (ULN) at screening
- Uncontrolled tumor-related hypercalcemia
Contact:
- Frédérique Cantero, MD
- frederique.cantero@basilea.com
- +41 76 830 2499
Locations:
- Yale University
- New Haven Connecticut 06520 United States
- NEXT Oncology
- San Antonio Texas 78229 United States
- Medical Oncology Associates PS (dba Summit Cancer Centers)
- Spokane Washington 99208 United States
- Medical Oncology Associates PS
- Spokane Washington 99208 United States
- Allgemeines Krankenhaus der Stadt Wien (AKH)
- Wien 1090 Austria
- Maria Middelares ZH Gent
- Gent 9000 Belgium
- CHA Centre Hospitalier de l Ardenne
- Libramont 6800 Belgium
- Institute Bergonie
- Bordeaux 33076 France
- CHU Timone / CEPCM
- Marseille 13005 France
- Hopitaux Universitaires Pitie-Salpetriere Charles-Foix
- Paris 75013 France
- Institut de Cancerologie de lOuest ICO – Rene Gauducheau
- Saint-Herblain 44805 France
- Institut Gustave Roussy
- Villejuif 94800 France
- Campus Charite Mitte
- Berlin 10117 Germany
- Studienpraxis Urologie
- Nürtingen 72622 Germany
- Bacs- Kiskun Megyei Korhaz
- Kecskemét 6000 Hungary
- ASST Istituti Ospitalieri
- Cremona 26100 Italy
- Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico
- Milan 20122 Italy
- IRCCS – Istituto Europeo di Oncologia IEO
- Milan 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
- Seoul National University Bundang Hospital
- Seongnam-si 463-707 Korea, Republic of
- Seoul National University Hospital
- Seoul 110-744 Korea, Republic of
- Korea University Anam Hospital
- Seoul 2841 Korea, Republic of
- Asan Medical Center
- Seoul 5505 Korea, Republic of
- Vall d Hebron Hospital
- Barcelona 8035 Spain
- ICO Hospitalet
- Barcelona 8908 Spain
- Hospital Universitario HM Sanchinarro CIOCC
- Madrid 28050 Spain
- Marqus de Valdecilla University Hospital
- Santander 39011 Spain
- The Sarah Cannon Research Institute
- London W1G6AD United Kingdom
View trial on ClinicalTrials.gov
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