An Open-label Multi-cohort Phase 1b/2 Study of Derazantinib and Atezolizumab in Patients With Urothelial Cancer Expressing Activating Molecular FGFR Aberrations

INTRODUCTION

  • Org Study ID: DZB-CS-201
  • Secondary ID: 2019-000359-15
  • NTC ID: NCT04045613
  • Sponsor: Basilea Pharmaceutica

BRIEF 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.

DETAILED 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.

  • Overall Status
    Recruiting
  • Start Date
    July 25, 2019
  • Phase
    Phase 1, Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Overall Response Rate (ORR) based on RECIST 1.1

Primary Outcome 1 - Timeframe: Approximately up to 2 years

Primary Outcome 2 - Measure: Safety and tolerability of derazantinib 200 mg twice a day with atezolizumab 1200 mg every three weeks

Primary Outcome 2 - Timeframe: After enrollment of the first 10 patients in substudy 3

Primary Outcome 3 - Measure: Safety and tolerability of derazantinib 200 mg twice a day as monotherapy

Primary Outcome 3 - Timeframe: After enrollment of the first 10 patients in substudy 5

CONDITION

  • Urothelial Carcinoma

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Manuel Häckl, MD

Role: Study Director

Affiliation: Basilea Pharmaceutica International Ltd

Overall Contact

Name: Manuel Häckl, MD

Phone: +41 76 302 53 10, +41 79 121 15 61

Email: manuel.haeckl@basilea.com, stephan.braun@basilea.com

LOCATION

Facility Status Contact
Facility: University Cancer and Blood Center
Athens, Georgia 30607
United States
Status: Recruiting Contact: N/A
Facility: CTCA Clinical Research Inc., Atlanta
Newnan, Georgia 30265
United States
Status: Recruiting Contact: N/A
Facility: Midwestern Regional Medical Center, Inc. DBA CTCA, Chicago
Zion, Illinois 60099
United States
Status: Recruiting Contact: N/A
Facility: The University of Kansas Cancer Center
Kansas City, Kansas 66160
United States
Status: Recruiting Contact: N/A
Facility: Norton Cancer Institute, Norton Healthcare Pavilion
Louisville, Kentucky 40202
United States
Status: Recruiting Contact: N/A
Facility: Englander Institute Weill Cornell Medicine
New York, New York 10021
United States
Status: Recruiting Contact: N/A
Facility: New York Cancer and Blood Specialists
Port Jefferson Station, New York 11776
United States
Status: Recruiting Contact: N/A
Facility: Greenville Health System - Prisma Health Cancer Institute
Greenville, South Carolina 29605
United States
Status: Recruiting Contact: N/A
Facility: University of Texas Southwestern Medical Center (UTSWMC)
Dallas, Texas 75390-8852
United States
Status: Recruiting Contact: N/A
Facility: MD Anderson
Houston, Texas 77030
United States
Status: Recruiting Contact: N/A
Facility: NEXT Oncology
San Antonio, Texas 78229
United States
Status: Recruiting Contact: N/A
Facility: University of Virginia Health System
Charlottesville, Virginia 22908
United States
Status: Recruiting Contact: N/A
Facility: Medical Oncology Associates PS (dba Summit Cancer Centers)
Spokane, Washington 99208
United States
Status: Recruiting Contact: N/A
Facility: Coastal Cancer Care
Birtinya, 4575
Australia
Status: Recruiting Contact: N/A
Facility: Canberra Hospital and Health Services
Canberra, 2065
Australia
Status: Recruiting Contact: N/A
Facility: John Flynn Private Hospital
Tugun, 4224
Australia
Status: Recruiting Contact: N/A
Facility: Ballarat Oncology & Haematology Services
Wendouree, 3355
Australia
Status: Recruiting Contact: N/A
Facility: Westmead Hospital
Westmead, 2145
Australia
Status: Recruiting Contact: N/A
Facility: Ordensklinikum Linz GmbH Elisabethinen
Linz, 4020
Austria
Status: Recruiting Contact: N/A
Facility: Krankenhaus Barmherzige Brüder Wien
Vienna, 1020
Austria
Status: Recruiting Contact: N/A
Facility: Universitair Ziekenhuis Brussel
Jette, 1090
Belgium
Status: Recruiting Contact: N/A
Facility: CHA Centre Hospitalier de l'Ardenne
Libramont, 6800
Belgium
Status: Recruiting Contact: N/A
Facility: Cross Cancer Institute Alberta Health Services
Edmonton, T6G 1Z2
Canada
Status: Recruiting Contact: N/A
Facility: Juravinski Cancer Center
Hamilton, L8V 5C2
Canada
Status: Recruiting Contact: N/A
Facility: Fakultni nemocnice u sv. Anny v Brne
Brno, 61700
Czechia
Status: Recruiting Contact: N/A
Facility: Fakultni Nemocnice Olomouc
Olomouc, 77900
Czechia
Status: Recruiting Contact: N/A
Facility: Nemocnice na Bulovce
Prague, 18081
Czechia
Status: Recruiting Contact: N/A
Facility: Institut Bergonie
Bordeaux, 33076 CEDEX
France
Status: Recruiting Contact: N/A
Facility: Centre François Baclesse
Caen, 14000
France
Status: Recruiting Contact: N/A
Facility: CHU Timone / CEPCM
Marseille, 13005
France
Status: Recruiting Contact: N/A
Facility: Medical Oncology - Pitié-Salpêtrière Hopital
Paris, 75030
France
Status: Recruiting Contact: N/A
Facility: IUCT-Oncopole de Toulouse
Toulouse, 31100
France
Status: Recruiting Contact: N/A
Facility: Institut Gustave Roussy
Villejuif, 94805
France
Status: Recruiting Contact: N/A
Facility: Campus Charite Mitte
Berlin, 10117
Germany
Status: Recruiting Contact: N/A
Facility: Universitaetsklinikum Carl Gustav Carus
Dresden, 01307
Germany
Status: Recruiting Contact: N/A
Facility: University Clinic Erlangen
Erlangen, 91054
Germany
Status: Recruiting Contact: N/A
Facility: Studienpraxis Urologie
Nürtingen, 72622
Germany
Status: Recruiting Contact: N/A
Facility: National Institute of Oncology
Budapest, 1122
Hungary
Status: Recruiting Contact: N/A
Facility: Onkolgiai Klinika
Debrecen, 4032
Hungary
Status: Recruiting Contact: N/A
Facility: Bacs- Kiskun Megyei Korhaz
Kecskemét, 6000
Hungary
Status: Recruiting Contact: N/A
Facility: B.A.Z.Megyei Központi Kórház és Egyetemi Oktató Kórház
Miskolc, 3526
Hungary
Status: Recruiting Contact: N/A
Facility: ASST Istituti Ospitalieri
Cremona, 26100
Italy
Status: Recruiting Contact: N/A
Facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milano, 20122
Italy
Status: Recruiting Contact: N/A
Facility: Fondazione IRCCS Istituto Nazionale dei Tumori
Milano, 20133
Italy
Status: Recruiting Contact: N/A
Facility: IRCCS - Istituto Europeo di Oncologia IEO
Milano, 20141
Italy
Status: Recruiting Contact: N/A
Facility: Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
Siena, 53100
Italy
Status: Recruiting Contact: N/A
Facility: ASST Valtellina e Alto Lario - UOC Oncologia Medica Ospedale di Sondrio
Sondrio, 23100
Italy
Status: Recruiting Contact: N/A
Facility: Inje University Haeundae Paik Hospital
Busan, 48108
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Pusan National University Hospital
Busan, 49241
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Chungnam National University Hospital
Daejeon, 35105
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: National Cancer Center
Goyang-si, 10408
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Gachon University Gil Medical Center
Incheon, 21565
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Seoul National University Bundang Hospital
Seongnam-si, 13620
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Korea University Anam Hospital
Seoul, 02841
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Seoul National University Hospital
Seoul, 110-744
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Yonsei University Health System
Seoul, 3722
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Asan Medical Center
Seoul, 5505
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Seoul St. Marys Hospital Catholic University of Korea
Seoul, 6591
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego
Lublin, 20-718
Poland
Status: Recruiting Contact: N/A
Facility: Med-Polonia Sp. z o. o.
Poznań, 60-693
Poland
Status: Recruiting Contact: N/A
Facility: Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o., 04-073, Warszawa, Poland
Warszawa, 04-073
Poland
Status: Recruiting Contact: N/A
Facility: Mazowiecki Szpital Onkologiczny
Wieliszew, 05-135
Poland
Status: Recruiting Contact: N/A
Facility: Vall d Hebron Hospital
Barcelona, 08035
Spain
Status: Recruiting Contact: N/A
Facility: Hospital del Mar
Barcelona, 8003
Spain
Status: Recruiting Contact: N/A
Facility: IOB - Hospital Quiron Salud
Barcelona, 8023
Spain
Status: Recruiting Contact: N/A
Facility: ICO Hospitalet
Barcelona, 8908
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario HM Sanchinarro CIOCC
Madrid, 28050
Spain
Status: Recruiting Contact: N/A
Facility: Marques de Valdecilla University Hospital
Santander, 39011
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario Virgen Macarena
Sevilla, 14009
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario Virgen del Rocio
Sevilla, 41013
Spain
Status: Recruiting Contact: N/A
Facility: Kantonsspital Graubünden
Chur, 7000
Switzerland
Status: Recruiting Contact: N/A
Facility: Lausanne University Hospital
Lausanne, 1011
Switzerland
Status: Recruiting Contact: N/A
Facility: UniversitaetsSpital Zuerich
Zürich, 8091
Switzerland
Status: Recruiting Contact: N/A
Facility: Barts and The London School of Medicine and Dentistry - Barts Cancer Institute (BCI)
London, EC1M 6BQ
United Kingdom
Status: Recruiting Contact: N/A
Facility: The Sarah Cannon Research Institute
London, W1G 6AD
United Kingdom
Status: Recruiting Contact: N/A
Facility: University College London Hospitals
London, W1T7HA
United Kingdom
Status: Recruiting Contact: N/A
Facility: The Royal Marsden NHS Foundation Trust
Sutton, SM2 5PT
United Kingdom
Status: Recruiting Contact: N/A