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History of Changes for Study: NCT04045613
Derazantinib and Atezolizumab in Patients With Urothelial Cancer (FIDES-02)
Latest version (submitted August 8, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 2, 2019 None (earliest Version on record)
2 November 29, 2019 Study Status and Contacts/Locations
3 December 5, 2019 Study Status and Contacts/Locations
4 March 4, 2020 Contacts/Locations and Study Status
5 March 11, 2020 Contacts/Locations and Study Status
6 April 6, 2020 Study Status and Contacts/Locations
7 May 7, 2020 Study Status and Contacts/Locations
8 July 9, 2020 Study Status and Contacts/Locations
9 August 5, 2020 Contacts/Locations and Study Status
10 September 24, 2020 Contacts/Locations, Study Status, Eligibility and Study Design
11 October 21, 2020 Contacts/Locations and Study Status
12 January 27, 2021 Contacts/Locations and Study Status
13 March 24, 2021 Study Status and Contacts/Locations
14 April 28, 2021 Contacts/Locations, Arms and Interventions, Outcome Measures, Study Description, Study Status, Eligibility and Study Design
15 June 2, 2021 Study Status and Contacts/Locations
16 June 17, 2021 Contacts/Locations and Study Status
17 July 15, 2021 Arms and Interventions, Study Status and Eligibility
18 February 7, 2022 Contacts/Locations and Study Status
19 June 1, 2022 Study Status and Contacts/Locations
20 July 8, 2022 Study Status and Contacts/Locations
21 August 8, 2022 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT04045613
Submitted Date:  August 2, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: DZB-CS-201
Brief Title: Derazantinib and Atezolizumab in Patients With Urothelial Cancer (FIDES-02)
Official Title: An Open-label Multi-cohort Phase 1b/2 Study of Derazantinib and Atezolizumab in Patients With Urothelial Cancer Expressing Activating Molecular FGFR Aberrations
Secondary IDs: 2019-000359-15 [EudraCT Number]
Open or close this module Study Status
Record Verification: August 2019
Overall Status: Recruiting
Study Start: July 25, 2019
Primary Completion: April 2022 [Anticipated]
Study Completion: May 2022 [Anticipated]
First Submitted: July 26, 2019
First Submitted that
Met QC Criteria:
August 2, 2019
First Posted: August 5, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
August 2, 2019
Last Update Posted: August 5, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Basilea Pharmaceutica
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: Urothelial Carcinoma
Keywords: metastatic urothelial cancer
bladder cancer
Fibroblast Growth Factor Receptor
FGFR genetic aberration
targeted therapy
derazantinib
checkpoint inhibitor
immune checkpoint blockade
atezolizumab
Tecentriq
solid tumor
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 4
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 303 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Derazantinib [Substudy 1]
Patients with urothelial cancer who have progressed on at least one line of standard treatment will be treated with derazantinib.
Drug: Derazantinib

Substudy 1: Derazantinib will be administered orally at a dose of 300mg once per day

Substudy 2: Derazantinib will be administered orally at various dose levels

Substudy 3 and 4: Derazantinib will be administered orally at the dose of 300mg once per day as single agent or at the identified RP2D for derazantinib-atezolizumab

Experimental: Derazantinib + Atezolizumab: Dose finding [Substudy 2]
Dose finding and dose expansion in patients with solid tumor.
Drug: Derazantinib

Substudy 1: Derazantinib will be administered orally at a dose of 300mg once per day

Substudy 2: Derazantinib will be administered orally at various dose levels

Substudy 3 and 4: Derazantinib will be administered orally at the dose of 300mg once per day as single agent or at the identified RP2D for derazantinib-atezolizumab

Drug: Atezolizumab (drug supplied by Hoffmann-La Roche)
Atezolizumab will be intravenously administered every 3 weeks at a dose of 1200mg.
Experimental: Derazantinib +/- Atezolizumab: First line [Substudy 3]
Patients with urothelial cancer will be randomized for first-line treatment with either derazantinib alone or the recommended phase 2 dose (RP2D) for derazantinib-atezolizumab.
Drug: Derazantinib

Substudy 1: Derazantinib will be administered orally at a dose of 300mg once per day

Substudy 2: Derazantinib will be administered orally at various dose levels

Substudy 3 and 4: Derazantinib will be administered orally at the dose of 300mg once per day as single agent or at the identified RP2D for derazantinib-atezolizumab

Drug: Atezolizumab (drug supplied by Hoffmann-La Roche)
Atezolizumab will be intravenously administered every 3 weeks at a dose of 1200mg.
Experimental: Derazantinib +/- Atezolizumab: Second line [Substudy 4]
Patients with urothelial cancer progressing after prior FGFR inhibitor treatment will be randomized to receive either derazantinib alone or the RP2D for derazantinib-atezolizumab.
Drug: Derazantinib

Substudy 1: Derazantinib will be administered orally at a dose of 300mg once per day

Substudy 2: Derazantinib will be administered orally at various dose levels

Substudy 3 and 4: Derazantinib will be administered orally at the dose of 300mg once per day as single agent or at the identified RP2D for derazantinib-atezolizumab

Drug: Atezolizumab (drug supplied by Hoffmann-La Roche)
Atezolizumab will be intravenously administered every 3 weeks at a dose of 1200mg.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Overall Response Rate (ORR) based on RECIST 1.1
[ Time Frame: Approximately up to 2 years ]

2. Recommended Phase 2 dose (RP2D) of derazantinib in combination with atezolizumab
[ Time Frame: Approximately up to 8 weeks ]

Secondary Outcome Measures:
1. Disease control rate per RECIST 1.1
[ Time Frame: Approximately up to 2 years ]

2. Duration of Response per RECIST 1.1
[ Time Frame: Approximately up to 2 years ]

3. Median progression-free survival (PFS) and PFS at 6 months
[ Time Frame: Approximately up to 2 years ]

4. Median overall survival (OS) and OS at 6 months
[ Time Frame: Approximately up to 2 years ]

5. Safety and tolerability of study treatment based on incidence of treatment-emergent adverse events
[ Time Frame: Approximately up to 2 years ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Frédérique Cantero, MD
Telephone: +41 76 830 2499
Email: frederique.cantero@basilea.com
Central Contact Backup: Stephan Braun, MD
Telephone: +41 79 121 1561
Email: stephan.braun@basilea.com
Study Officials: Frédérique Cantero, MD
Study Director
Basilea Pharmaceutica International Ltd
Locations: United States, Connecticut
Yale University
[Not yet recruiting]
New Haven, Connecticut, United States, 06520
United States, Washington
Medical Oncology Associates PS
[Recruiting]
Spokane, Washington, United States, 99208
Austria
Allgemeines Krankenhaus der Stadt Wien (AKH)
[Not yet recruiting]
Wien, Austria, 1090
Belgium
Maria Middelares ZH Gent
[Not yet recruiting]
Gent, Belgium, 9000
CHA Centre Hospitalier de l Ardenne
[Not yet recruiting]
Libramont, Belgium, 6800
France
Institute Bergonie
[Not yet recruiting]
Bordeaux, France, 33076
CHU Timone / CEPCM
[Not yet recruiting]
Marseille, France, 13005
Hopitaux Universitaires Pitie-Salpetriere Charles-Foix
[Not yet recruiting]
Paris, France, 75013
Institut de Cancerologie de lOuest ICO - Rene Gauducheau
[Not yet recruiting]
Saint-Herblain, France, 44805
Institut Gustave Roussy
[Not yet recruiting]
Villejuif, France, 94800
Germany
Campus Charite Mitte
[Not yet recruiting]
Berlin, Germany, 10117
Studienpraxis Urologie
[Not yet recruiting]
Nürtingen, Germany, 72622
Hungary
Bacs- Kiskun Megyei Korhaz
[Not yet recruiting]
Kecskemét, Hungary, 6000
Italy
ASST Istituti Ospitalieri
[Not yet recruiting]
Cremona, Italy, 26100
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
[Not yet recruiting]
Milan, Italy, 20122
IRCCS - Istituto Europeo di Oncologia IEO
[Not yet recruiting]
Milan, Italy, 20141
Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
[Not yet recruiting]
Siena, Italy, 53100
ASST Valtellina e Alto Lario - UOC Oncologia Medica Ospedale di Sondrio
[Not yet recruiting]
Sondrio, Italy, 23100
Korea, Republic of
Inje University Haeundae Paik Hospital
[Not yet recruiting]
Busan, Korea, Republic of, 48108
Seoul National University Bundang Hospital
[Not yet recruiting]
Seongnam-si, Korea, Republic of, 463-707
Seoul National University Hospital
[Not yet recruiting]
Seoul, Korea, Republic of, 110-744
Korea University Anam Hospital
[Not yet recruiting]
Seoul, Korea, Republic of, 2841
Asan Medical Center
[Not yet recruiting]
Seoul, Korea, Republic of, 5505
Spain
Vall d Hebron Hospital
[Not yet recruiting]
Barcelona, Spain, 8035
ICO Hospitalet
[Not yet recruiting]
Barcelona, Spain, 8908
Hospital Universitario HM Sanchinarro CIOCC
[Not yet recruiting]
Madrid, Spain, 28050
Marqus de Valdecilla University Hospital
[Not yet recruiting]
Santander, Spain, 39011
United Kingdom
The Sarah Cannon Research Institute
[Not yet recruiting]
London, United Kingdom, W1G6AD
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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