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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04045613
Ethics application status
Date submitted
26/07/2019
Date registered
5/08/2019

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 300 mg once daily monotherapy
Treatment: Drugs - Derazantinib 200 mg once daily + atezolizumab 1200 mg
Treatment: Drugs - Derazantinib 300 mg once daily+ atezolizumab 1200 mg
Treatment: Drugs - Derazantinib 200 mg twice daily + atezolizumab 1200 mg
Treatment: Drugs - Derazantinib 300 mg once daily monotherapy (QD)
Treatment: Drugs - Derazantinib 300 mg once daily + atezolizumab 1200 mg
Treatment: Drugs - Derazantinib 200 mg twice daily monotherapy

Experimental: Substudy 1: Derazantinib 300 mg once daily - Patients with urothelial cancer were treated with derazantinib 300 mg once daily

Experimental: Substudy 2 (Dose-Level 1): Derazantinib 200 mg once daily + atezolizumab 1200 mg - Patients with any solid tumors were treated with derazantinib 200 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as intravenous (IV) infusion

Experimental: Substudy 2 (Dose-Level 2): Derazantinib 300 mg once daily + atezolizumab 1200 mg - Patients with any solid tumors were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion

Experimental: Substudy 3: Derazantinib 200 mg twice daily + atezolizumab 1200 mg - Patients with urothelial cancer were treated with derazantinib 200 mg twice daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion

Experimental: Substudy 4 (Cohort 4a):Derazantinib 300 mg once daily - Patients with FGFR inhibitor resistant urothelial cancer were treated with derazantinib 300 mg once daily

Experimental: Substudy 4 (Cohort 4b):Derazantinib 300 mg once daily + atezolizumab 1200 mg - Patients with urothelial cancer were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion

Experimental: Substudy 5: Derazantinib 200 mg twice daily - Patients with urothelial cancer were treated with derazantinib 200 mg twice daily


Treatment: Drugs: Derazantinib 300 mg once daily monotherapy
Derazantinib was administered orally at a dose of 300 mg once daily

Treatment: Drugs: Derazantinib 200 mg once daily + atezolizumab 1200 mg
Derazantinib was administered orally at a dose of 200 mg once daily in combination with atezolizumab 1200 mg every 3 weeks

Treatment: Drugs: Derazantinib 300 mg once daily+ atezolizumab 1200 mg
Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks

Treatment: Drugs: Derazantinib 200 mg twice daily + atezolizumab 1200 mg
Derazantinib was administered orally at a dose of 200 mg twice daily in combination with atezolizumab 1200 mg every 3 weeks

Treatment: Drugs: Derazantinib 300 mg once daily monotherapy (QD)
Derazantinib was administered orally at a dose of 300 mg once daily

Treatment: Drugs: Derazantinib 300 mg once daily + atezolizumab 1200 mg
Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks

Treatment: Drugs: Derazantinib 200 mg twice daily monotherapy
Derazantinib was administered orally at a dose of 200 mg twice daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR) Based on RECIST 1.1 (Substudies 1,3,4 and 5)
Timepoint [1] 0 0
From first dose up to 2 years
Primary outcome [2] 0 0
Recommended Phase 2 Dose (RP2D) of Derazantinib-atezolizumab in Combination Based on DLT Criteria, Safety and Efficacy Data (Substudy 2)
Timepoint [2] 0 0
From first dose up to 2 years
Primary outcome [3] 0 0
Number of Patients With Dose-limiting Toxicities (DLTs) in Substudy 2
Timepoint [3] 0 0
From first dose up to 2 years
Secondary outcome [1] 0 0
Disease Control Rate (DCR) Per RECIST 1.1 in All Substudies
Timepoint [1] 0 0
From first dose up to 2 years
Secondary outcome [2] 0 0
Duration of Response (DOR) Per RECIST 1.1
Timepoint [2] 0 0
From first dose up to 2 years
Secondary outcome [3] 0 0
ORR Based on RECIST 1.1 (Substudy 2)
Timepoint [3] 0 0
From first dose up to 2 years
Secondary outcome [4] 0 0
Progression-free Survival (PFS) by RECIST in All Substudies
Timepoint [4] 0 0
From first dose up to 2 years
Secondary outcome [5] 0 0
Overall Survival (OS) in All Substudies
Timepoint [5] 0 0
From first dose up to 2 years
Secondary outcome [6] 0 0
Number of Patients With at Least Grade 3 Adverse Events (AEs)
Timepoint [6] 0 0
From first dose and until 90 days following the last dose

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 aberration (FGFR1, FGFR2, or FGFR3 mutations / short variants and rearrangements / fusions) (Note; Substudy 2 started with patients requiring an FGFR GA, but this requirement was removed from the protocol later on)
* Measurable disease, as defined by the Investigator using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
* Adequate organ functions as indicated by Screening visit local laboratory values
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Receipt of prior cancer treatment within specific interval periods
* Concurrent evidence of any clinically significant corneal or retinal disorder
* History of clinically significant cardiac disorders
* Known CNS metastases
* Concurrent uncontrolled or active infection with human immunodeficiency virus
* Active hepatitis B or chronic hepatitis B without current antiviral therapy
* Active hepatitis C
* Active tuberculosis
* Severe bacterial, fungal, viral and/or parasitic infections on therapeutic oral or IV medication at the time of first dose of study drug administration

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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/08/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/10/2022
Sample size
Target
Accrual to date
Final
95
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
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
United States of America
State/province [4] 0 0
Washington
Country [5] 0 0
Austria
State/province [5] 0 0
Vienna
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Canada
State/province [7] 0 0
Hamilton
Country [8] 0 0
Czechia
State/province [8] 0 0
Brno
Country [9] 0 0
Czechia
State/province [9] 0 0
Olomouc
Country [10] 0 0
France
State/province [10] 0 0
Bordeaux
Country [11] 0 0
France
State/province [11] 0 0
Caen
Country [12] 0 0
France
State/province [12] 0 0
Marseille
Country [13] 0 0
France
State/province [13] 0 0
Paris
Country [14] 0 0
France
State/province [14] 0 0
Toulouse
Country [15] 0 0
France
State/province [15] 0 0
Villejuif
Country [16] 0 0
Germany
State/province [16] 0 0
Berlin
Country [17] 0 0
Germany
State/province [17] 0 0
Duesseldorf
Country [18] 0 0
Germany
State/province [18] 0 0
Erlangen
Country [19] 0 0
Germany
State/province [19] 0 0
Magdeburg
Country [20] 0 0
Germany
State/province [20] 0 0
Nürtingen
Country [21] 0 0
Hungary
State/province [21] 0 0
Budapest
Country [22] 0 0
Hungary
State/province [22] 0 0
Kecskemét
Country [23] 0 0
Italy
State/province [23] 0 0
Milano
Country [24] 0 0
Italy
State/province [24] 0 0
Siena
Country [25] 0 0
Italy
State/province [25] 0 0
Sondrio
Country [26] 0 0
Korea, Republic of
State/province [26] 0 0
Busan
Country [27] 0 0
Korea, Republic of
State/province [27] 0 0
Daejeon
Country [28] 0 0
Korea, Republic of
State/province [28] 0 0
Goyang-si
Country [29] 0 0
Korea, Republic of
State/province [29] 0 0
Incheon
Country [30] 0 0
Korea, Republic of
State/province [30] 0 0
Seongnam-si
Country [31] 0 0
Korea, Republic of
State/province [31] 0 0
Seoul
Country [32] 0 0
Poland
State/province [32] 0 0
Lublin
Country [33] 0 0
Poland
State/province [33] 0 0
Poznan
Country [34] 0 0
Poland
State/province [34] 0 0
Warszawa
Country [35] 0 0
Poland
State/province [35] 0 0
Wieliszew
Country [36] 0 0
Spain
State/province [36] 0 0
Barcelona
Country [37] 0 0
Spain
State/province [37] 0 0
Madrid
Country [38] 0 0
Spain
State/province [38] 0 0
Santander
Country [39] 0 0
Spain
State/province [39] 0 0
Sevilla
Country [40] 0 0
Switzerland
State/province [40] 0 0
Chur
Country [41] 0 0
Switzerland
State/province [41] 0 0
Lausanne
Country [42] 0 0
Switzerland
State/province [42] 0 0
Zürich
Country [43] 0 0
United Kingdom
State/province [43] 0 0
London
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Sutton

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Manuel Häckl, MD
Address 0 0
Basilea Pharmaceutica International Ltd, Allschwil
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04045613