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

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


  • Org Study ID: DZB-CS-201
  • Secondary ID: 2019-000359-15
  • NCT ID: NCT04045613
  • NCT Alias:
  • Sponsor: Basilea Pharmaceutica - Industry
  • Source: Basilea Pharmaceutica

Brief Summary

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.

Detailed Description


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 Outcomes:

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

Condition:

  • Urothelial Carcinoma

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 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

Official Information

Name: Frédérique Cantero, MD

Role: Study Director

Affiliation: Basilea Pharmaceutica International Ltd

Overall Contact

Name: Frédérique Cantero, MD

Phone: +41 76 830 2499

Email: Frederique.Cantero@basilea.com

Locations

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
Ballarat Oncology & Haematology Services
Wendouree, 3355
Australia
Recruiting
Krankenhaus Barmherzige Brder Wien
Vienna, 1020
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
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
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
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano, 20133
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
Hospital del Mar
Barcelona, 08003
Spain
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