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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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