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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 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
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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
Yale University
New Haven, Connecticut 06520
United States
Not yet recruiting
Medical Oncology Associates PS
Spokane, Washington 99208
United States
Recruiting
Allgemeines Krankenhaus der Stadt Wien (AKH)
Wien, 1090
Austria
Not yet recruiting
Maria Middelares ZH Gent
Gent, 9000
Belgium
Not yet recruiting
CHA Centre Hospitalier de l Ardenne
Libramont, 6800
Belgium
Not yet recruiting
Institute Bergonie
Bordeaux, 33076
France
Not yet recruiting
CHU Timone / CEPCM
Marseille, 13005
France
Not yet recruiting
Hopitaux Universitaires Pitie-Salpetriere Charles-Foix
Paris, 75013
France
Not yet recruiting
Institut de Cancerologie de lOuest ICO - Rene Gauducheau
Saint-Herblain, 44805
France
Not yet recruiting
Institut Gustave Roussy
Villejuif, 94800
France
Not yet recruiting
Campus Charite Mitte
Berlin, 10117
Germany
Not yet recruiting
Studienpraxis Urologie
Nürtingen, 72622
Germany
Not yet recruiting
Bacs- Kiskun Megyei Korhaz
Kecskemét, 6000
Hungary
Not yet recruiting
ASST Istituti Ospitalieri
Cremona, 26100
Italy
Not yet recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
Italy
Not yet recruiting
IRCCS - Istituto Europeo di Oncologia IEO
Milan, 20141
Italy
Not yet recruiting
Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
Siena, 53100
Italy
Not yet recruiting
ASST Valtellina e Alto Lario - UOC Oncologia Medica Ospedale di Sondrio
Sondrio, 23100
Italy
Not yet recruiting
Inje University Haeundae Paik Hospital
Busan, 48108
Korea, Republic of
Not yet recruiting
Seoul National University Bundang Hospital
Seongnam-si, 463-707
Korea, Republic of
Not yet recruiting
Seoul National University Hospital
Seoul, 110-744
Korea, Republic of
Not yet recruiting
Korea University Anam Hospital
Seoul, 2841
Korea, Republic of
Not yet recruiting
Asan Medical Center
Seoul, 5505
Korea, Republic of
Not yet recruiting
Vall d Hebron Hospital
Barcelona, 8035
Spain
Not yet recruiting
ICO Hospitalet
Barcelona, 8908
Spain
Not yet recruiting
Hospital Universitario HM Sanchinarro CIOCC
Madrid, 28050
Spain
Not yet recruiting
Marqus de Valdecilla University Hospital
Santander, 39011
Spain
Not yet recruiting
The Sarah Cannon Research Institute
London, W1G6AD
United Kingdom
Not yet recruiting