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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04045613




Registration number
NCT04045613
Ethics application status
Date submitted
26/07/2019
Date registered
5/08/2019
Date last updated
30/04/2021

Titles & IDs
Public title
Derazantinib and Atezolizumab in Patients With Urothelial Cancer
Scientific 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 ID [1] 0 0
2019-000359-15
Secondary ID [2] 0 0
DZB-CS-201
Universal Trial Number (UTN)
Trial acronym
FIDES-02
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urothelial Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Bladder - transitional cell cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Derazantinib
Treatment: Drugs - Atezolizumab (drug supplied by Hoffmann-La Roche)

Experimental: Derazantinib [Substudy 1] - Patients with urothelial cancer who have progressed on at least one line of standard treatment will be treated with derazantinib dose level 1.

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

Experimental: Derazantinib +/- Atezolizumab: First line [Substudy 3] - Patients with urothelial cancer will be treated with a combination of derazantinib and atezolizumab.

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 a combination of derazantinib and atezolizumab.

Experimental: Derazantinib [Substudy 5] - Patients with urothelial cancer who have progressed on at least one line of standard treatment will be treated with derazantinib dose level 2.


Treatment: Drugs: Derazantinib
Substudy 1: Derazantinib will be administered orally at a dose of 300 mg once per day
Substudy 2: Derazantinib was administered orally at various dose levels and the RP2D of derazantinib in combination with atezolizumab was determined to be 300 mg once per day derazantinib plus 1200 mg atezolizumab every three weeks.
Substudy 3: Derazantinib will be administered orally at a dose of 200 mg twice daily in combination with atezolizumab 1200 mg every three weeks. If derazantinib 200 mg twice daily at the safety interim analysis is not assessed as safe and tolerable, patients are to be treated with 300 mg derazantinib once per day in combination with atezolizumab 1200 mg every three weeks.
Substudy 4: Derazantinib will be administered orally at a dose of 300 mg once per day as monotherapy or at 300 mg once per day in combination with atezolizumab 1200 mg every three weeks.
Substudy 5: Derazantinib will be administered orally at a dose of 200 mg twice daily as monotherapy.

Treatment: Drugs: Atezolizumab (drug supplied by Hoffmann-La Roche)
Atezolizumab will be intravenously administered every 3 weeks at a dose of 1200mg.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Response Rate (ORR) based on RECIST 1.1
Timepoint [1] 0 0
Approximately up to 2 years
Primary outcome [2] 0 0
Safety and tolerability of derazantinib 200 mg twice a day with atezolizumab 1200 mg every three weeks
Timepoint [2] 0 0
After enrollment of the first 10 patients in substudy 3
Primary outcome [3] 0 0
Safety and tolerability of derazantinib 200 mg twice a day as monotherapy
Timepoint [3] 0 0
After enrollment of the first 10 patients in substudy 5
Secondary outcome [1] 0 0
Disease control rate per RECIST 1.1
Timepoint [1] 0 0
Approximately up to 2 years
Secondary outcome [2] 0 0
Duration of Response per RECIST 1.1
Timepoint [2] 0 0
Approximately up to 2 years
Secondary outcome [3] 0 0
Median progression-free survival (PFS) and PFS at 6 months
Timepoint [3] 0 0
Approximately up to 2 years
Secondary outcome [4] 0 0
Median overall survival (OS) and OS at 6 months
Timepoint [4] 0 0
Approximately up to 2 years
Secondary outcome [5] 0 0
Safety and tolerability of study treatment based on incidence of treatment-emergent adverse events
Timepoint [5] 0 0
Approximately up to 2 years

Eligibility
Key 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 (FGFR1, FGFR2, or FGFR3 mutations 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Coastal Cancer Care - Birtinya
Recruitment hospital [2] 0 0
Canberra Hospital and Health Services - Canberra
Recruitment hospital [3] 0 0
John Flynn Private Hospital - Tugun
Recruitment hospital [4] 0 0
Ballarat Oncology & Haematology Services - Wendouree
Recruitment hospital [5] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
4575 - Birtinya
Recruitment postcode(s) [2] 0 0
2065 - Canberra
Recruitment postcode(s) [3] 0 0
4224 - Tugun
Recruitment postcode(s) [4] 0 0
3355 - Wendouree
Recruitment postcode(s) [5] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
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United States of America
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Illinois
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United States of America
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Kentucky
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United States of America
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New York
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United States of America
State/province [5] 0 0
South Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
United States of America
State/province [7] 0 0
Virginia
Country [8] 0 0
United States of America
State/province [8] 0 0
Washington
Country [9] 0 0
Austria
State/province [9] 0 0
Linz
Country [10] 0 0
Austria
State/province [10] 0 0
Vienna
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Belgium
State/province [11] 0 0
Jette
Country [12] 0 0
Belgium
State/province [12] 0 0
Libramont
Country [13] 0 0
Canada
State/province [13] 0 0
Hamilton
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Czechia
State/province [14] 0 0
Brno
Country [15] 0 0
Czechia
State/province [15] 0 0
Olomouc
Country [16] 0 0
Czechia
State/province [16] 0 0
Prague
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France
State/province [17] 0 0
Bordeaux
Country [18] 0 0
France
State/province [18] 0 0
Caen
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France
State/province [19] 0 0
Marseille
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France
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Paris
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France
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Toulouse
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France
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Villejuif
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Germany
State/province [23] 0 0
Berlin
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Germany
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Dresden
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Germany
State/province [25] 0 0
Erlangen
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Germany
State/province [26] 0 0
Nürtingen
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Hungary
State/province [27] 0 0
Budapest
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Hungary
State/province [28] 0 0
Debrecen
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Hungary
State/province [29] 0 0
Kecskemét
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Hungary
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Miskolc
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Italy
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Cremona
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Italy
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Milano
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Italy
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Siena
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Italy
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Sondrio
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Korea, Republic of
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Busan
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Korea, Republic of
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Daejeon
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Korea, Republic of
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Goyang-si
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seongnam-si
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Korea, Republic of
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Seoul
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Poland
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Lublin
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Poznan
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Poland
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Wieliszew
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Santander
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Spain
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Sevilla
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Switzerland
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Chur
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Switzerland
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Lausanne
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Switzerland
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Zürich
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United Kingdom
State/province [51] 0 0
London
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United Kingdom
State/province [52] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Basilea Pharmaceutica
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT04045613
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Manuel Häckl, MD
Address 0 0
Basilea Pharmaceutica International Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Manuel Häckl, MD
Address 0 0
Country 0 0
Phone 0 0
+41 76 302 53 10
Fax 0 0
Email 0 0
Manuel.Haeckl@basilea.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04045613