Urothelial CarcinomaPhase 1/2FIDES-02NCT04045613
Derazantinib and Atezolizumab in Patients With Urothelial Cancer
A Phase 1/2 study testing Derazantinib 300 mg once daily monotherapy, Derazantinib 200 mg once daily + atezolizumab 1200 mg and Derazantinib 300 mg once daily+ atezolizumab 1200 mg in people with Urothelial Carcinoma, run by Basilea Pharmaceutica at 66 sites in 14 countries.
Trial summary
The purpose of this study was 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma
- What is being tested?
- Derazantinib 300 mg once daily monotherapy, Derazantinib 200 mg once daily + atezolizumab 1200 mg and Derazantinib 300 mg once daily+ atezolizumab 1200 mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 66 sitesin 14 countries
- Study dates
- 2 Aug 2019to 4 Oct 2022
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
66 sites in 14 countries.
66 sites in 14 countries
South Korea11 sites
Inje University Haeundae Paik Hospital
Busan, 48108
Pusan National University Hospital
Busan, 49241
Chungnam National University Hospital
Daejeon, 35105
National Cancer Center
Goyang-si, 10408
Gachon University Gil Medical Center
Incheon, 21565
Seoul National University Bundang Hospital
Seongnam-si, 13620
Korea University Anam Hospital
Seoul, 02841
Seoul National University Hospital
Seoul, 110-744
Yonsei University Health System
Seoul, 3722
Asan Medical Center
Seoul, 5505
Seoul St. Marys Hospital Catholic University of Korea
Seoul, 6591
Spain8 sites
Vall d Hebron Hospital
Barcelona, 08035
Hospital del Mar
Barcelona, 8003
IOB - Hospital Quiron Salud
Barcelona, 8023
ICO Hospitalet
Barcelona, 8908
Hospital Universitario HM Sanchinarro CIOCC
Madrid, 28050
Marques de Valdecilla University Hospital
Santander, 39011
Hospital Universitario Virgen Macarena
Seville, 14009
Hospital Universitario Virgen del Rocio
Seville, 41013
United States7 sites
University of Texas Southwestern Medical Center (UTSWMC)
Dallas, Texas, 75390-8852
MD Anderson
Houston, Texas, 77030
Englander Institute Weill Cornell Medicine
New York, New York, 10021
CTCA Clinical Research Inc., Atlanta
Newnan, Georgia, 30265
New York Cancer and Blood Specialists
Port Jefferson Station, New York, 11776
NEXT Oncology
San Antonio, Texas, 78229
Medical Oncology Associates PS (dba Summit Cancer Centers)
Spokane, Washington, 99208
France6 sites
Institut Bergonie
Bordeaux, 33076 CEDEX
Centre François Baclesse
Caen, 14000
CHU Timone / CEPCM
Marseille, 13005
Medical Oncology - Pitié-Salpêtrière Hopital
Paris, 75030
IUCT-Oncopole de Toulouse
Toulouse, 31100
Institut Gustave Roussy
Villejuif, 94805
Italy6 sites
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
IRCCS Ospedale San Raffaele
Milan, 20132
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
IRCCS - Istituto Europeo di Oncologia IEO
Milan, 20141
Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
Siena, 53100
ASST Valtellina e Alto Lario - UOC Oncologia Medica Ospedale di Sondrio
Sondrio, 23100
Australia5 sites
Coastal Cancer Care
Birtinya, 4575
Canberra Hospital and Health Services
Canberra, 2065
John Flynn Private Hospital
Tugun, 4224
Ballarat Oncology & Haematology Services
Wendouree, 3355
Westmead Hospital
Westmead, 2145
Germany5 sites
Campus Charite Mitte
Berlin, 10117
Universitaetsklinikum Duesseldorf
Düsseldorf, 40225
University Clinic Erlangen
Erlangen, 91054
Universitaetsklinikum Magdeburg A.oe.R
Magdeburg, 39120
Studienpraxis Urologie
Nürtingen, 72622
Poland4 sites
Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego
Lublin, 20-718
Med-Polonia Sp. z o. o.
Poznan, 60-693
Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o., 04-073, Warszawa, Poland
Warsaw, 04-073
Mazowiecki Szpital Onkologiczny
Wieliszew, 05-135
United Kingdom4 sites
Barts and The London School of Medicine and Dentistry - Barts Cancer Institute (BCI)
London, EC1M 6BQ
The Sarah Cannon Research Institute
London, W1G 6AD
University College London Hospitals
London, W1T7HA
The Royal Marsden NHS Foundation Trust
Sutton, SM2 5PT
Switzerland3 sites
Kantonsspital Graubünden
Chur, 7000
Lausanne University Hospital
Lausanne, 1011
UniversitaetsSpital Zuerich
Zurich, 8091
Canada2 sites
Juravinski Cancer Center
Hamilton, L8V 5C2
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Czechia2 sites
Fakultni nemocnice u sv. Anny v Brne
Brno, 61700
Fakultni Nemocnice Olomouc
Olomouc, 77900
Hungary2 sites
National Institute of Oncology
Budapest, 1122
Bacs- Kiskun Megyei Korhaz
Kecskemét, 6000
Austria1 site
Medizinische Universitaet Wien - Allgemeines Krankenhaus der Stadt Wien (AKH) - Universitaetsklinik fuer Urologie
Vienna, 1090
About this study
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
The purpose of this study was 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.
Read the detailed description
The study comprised five open-label substudies (1-5) in patients with advanced urothelial cancer harboring FGFR GA (with the exception of substudy 2 which did not require a FGFR GA) who were treated by derazantinib monotherapy or derazantinib in combination with atezolizumab. The study enrolled patients with cisplatin-ineligible status, or patients whose disease progressed after either first-line treatment or prior treatment with FGFR inhibitors.
- Conditions
- Urothelial Carcinoma
- Being tested
- Derazantinib 300 mg once daily monotherapy, Derazantinib 200 mg once daily + atezolizumab 1200 mg, Derazantinib 300 mg once daily+ atezolizumab 1200 mg, Derazantinib 200 mg twice daily + atezolizumab 1200 mg, Derazantinib 300 mg once daily monotherapy (QD)
- 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
- Medical subject headings
- Carcinoma, Transitional Cell, Urinary Bladder Neoplasms, Acrocephalosyndactylia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Derazantinib 300 mg once daily monotherapyDrug
Derazantinib was administered orally at a dose of 300 mg once daily
Derazantinib 200 mg once daily + atezolizumab 1200 mgDrug
Derazantinib was administered orally at a dose of 200 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
Derazantinib 300 mg once daily+ atezolizumab 1200 mgDrug
Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
Derazantinib 200 mg twice daily + atezolizumab 1200 mgDrug
Derazantinib was administered orally at a dose of 200 mg twice daily in combination with atezolizumab 1200 mg every 3 weeks
Derazantinib 300 mg once daily monotherapy (QD)Drug
Derazantinib was administered orally at a dose of 300 mg once daily
Derazantinib 300 mg once daily + atezolizumab 1200 mgDrug
Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
Derazantinib 200 mg twice daily monotherapyDrug
Derazantinib was administered orally at a dose of 200 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| Substudy 1: Derazantinib 300 mg once daily | Experimental | Patients with urothelial cancer were treated with derazantinib 300 mg once daily Receives: Drug: Derazantinib 300 mg once daily monotherapy |
| Substudy 2 (Dose-Level 1): Derazantinib 200 mg once daily + atezolizumab 1200 mg | Experimental | 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 Receives: Drug: Derazantinib 200 mg once daily + atezolizumab 1200 mg |
| Substudy 2 (Dose-Level 2): Derazantinib 300 mg once daily + atezolizumab 1200 mg | Experimental | 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 Receives: Drug: Derazantinib 300 mg once daily+ atezolizumab 1200 mg |
| Substudy 3: Derazantinib 200 mg twice daily + atezolizumab 1200 mg | Experimental | 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 Receives: Drug: Derazantinib 200 mg twice daily + atezolizumab 1200 mg |
| Substudy 4 (Cohort 4a):Derazantinib 300 mg once daily | Experimental | Patients with FGFR inhibitor resistant urothelial cancer were treated with derazantinib 300 mg once daily Receives: Drug: Derazantinib 300 mg once daily monotherapy (QD) |
| Substudy 4 (Cohort 4b):Derazantinib 300 mg once daily + atezolizumab 1200 mg | Experimental | 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 Receives: Drug: Derazantinib 300 mg once daily + atezolizumab 1200 mg |
| Substudy 5: Derazantinib 200 mg twice daily | Experimental | Patients with urothelial cancer were treated with derazantinib 200 mg twice daily Receives: Drug: Derazantinib 200 mg twice daily monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) Based on RECIST 1.1 (Substudies 1,3,4 and 5)
ORR was defined as the proportion of patients who achieved a confirmed clinical response (CR) or partial response (PR) by blinded investigator central review (BICR) using the internationally recognized criteria for the radiological assessment in tumor response of solid tumors (RECIST) Version 1.1
Measured: From first dose up to 2 years
Recommended Phase 2 Dose (RP2D) of Derazantinib-atezolizumab in Combination Based on DLT Criteria, Safety and Efficacy Data (Substudy 2)
The RP2D was determined by a joint decision taken by the Independent Data Monitoring Committee (IDMC), Investigators, and the Sponsor in reviewing the aggregate of DLT and AE data, and considering efficacy data
Measured: From first dose up to 2 years
Number of Patients With Dose-limiting Toxicities (DLTs) in Substudy 2
In Substudy 2, the primary endpoint was the number of patients with DLTs. A DLT was defined as a clinically-significant adverse event (AE) or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications. Any DLT had to be a toxicity considered at least possibly related to derazantinib or the combination of derazantinib and atezolizumab
Measured: From first dose up to 2 years
Secondary outcomes (6)
Disease Control Rate (DCR) Per RECIST 1.1 in All Substudies
DCR was defined as the proportion of patients who achieved a confirmed clinical response (CR), partial response (PR) or stable disease (SD) by BICR using the internationally recognized criteria in accordance with RECIST Version 1.1
Measured: From first dose up to 2 years
Duration of Response (DOR) Per RECIST 1.1
DOR was calculated from the first date of documented tumor response (confirmed CR or PR) to the date of disease progression as assessed by BICR or death per RECIST 1.1
Measured: From first dose up to 2 years
ORR Based on RECIST 1.1 (Substudy 2)
ORR was defined as the proportion of patients who achieved a confirmed clinical response (CR) or partial response (PR) by blinded investigator central review (BICR) using the internationally recognized criteria for the radiological assessment in tumor response of solid tumors (RECIST) Version 1.1
Measured: From first dose up to 2 years
Progression-free Survival (PFS) by RECIST in All Substudies
PFS was calculated as the time from cohort assignment until disease progression as assessed by BICR, or death from any cause, whichever came first
Measured: From first dose up to 2 years
Overall Survival (OS) in All Substudies
OS was calculated from the date of cohort assignment until death from any cause
Measured: From first dose up to 2 years
Number of Patients With at Least Grade 3 Adverse Events (AEs)
Common Terminology Criteria for Adverse Events (CTCAE) displayed by increasing severity grades 3 to 5 (CTCAE grade 3/4/5 )
Measured: From first dose and until 90 days following the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start2 Aug 2019
- Primary completion4 Oct 2022
- Study completion4 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Basilea Pharmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Manuel Häckl, MD, Study director, Basilea Pharmaceutica International Ltd, Allschwil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04045613
- Sponsor's protocol ID
- DZB-CS-201
- Other IDs
- 2019-000359-15, 2019
- Acronym
- FIDES-02
- Status last verified
- Sep 2023
- First submitted
- 26 Jul 2019
- Last updated
- 13 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Necchi A, Ramlau R, Falcon Gonzalez A, Chaudhry A, Todenhofer T, Tahbaz R, Fontana E, Giannatempo P, Deville JL, Pouessel D, Yoon S, Powles T, Bernat M, Hackl M, Marszewska M, McKernan P, Saulay M, Scaleia F, Engelhardt M, Loriot Y, Siefker-Radtke A, De Santis M. Derazantinib alone and with atezolizumab in metastatic urothelial carcinoma with activating FGFR aberrations. JNCI Cancer Spectr. 2024 Apr 30;8(3):pkae030. doi: 10.1093/jncics/pkae030.
PubMed 38627238
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04045613
- Acronym / sponsor ID
- FIDES-02 / DZB-CS-201
- Conditions
- Urothelial Carcinoma
- Keywords
- metastatic urothelial cancer, bladder cancer, Fibroblast Growth Factor Receptor, FGFR genetic aberration, targeted therapy, derazantinib, checkpoint inhibitor, immune checkpoint blockade
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Basilea PharmaceuticaIndustry (pharma, biotech, devices)
- Study start
- 2 Aug 2019 (actual)
- Primary completion
- 4 Oct 2022 (actual)
- Study completion
- 4 Oct 2022 (actual)
- First posted
- 5 Aug 2019 (actual)
- Results
- Posted 13 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was 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.
Detailed description
The study comprised five open-label substudies (1-5) in patients with advanced urothelial cancer harboring FGFR GA (with the exception of substudy 2 which did not require a FGFR GA) who were treated by derazantinib monotherapy or derazantinib in combination with atezolizumab. The study enrolled patients with cisplatin-ineligible status, or patients whose disease progressed after either first-line treatment or prior treatment with FGFR inhibitors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Substudy 1: Derazantinib 300 mg once daily | Experimental | Drug: Derazantinib 300 mg once daily monotherapyPatients with urothelial cancer were treated with derazantinib 300 mg once daily |
| Substudy 2 (Dose-Level 1): Derazantinib 200 mg once daily + atezolizumab 1200 mg | Experimental | Drug: Derazantinib 200 mg once daily + atezolizumab 1200 mgPatients 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 |
| Substudy 2 (Dose-Level 2): Derazantinib 300 mg once daily + atezolizumab 1200 mg | Experimental | Drug: Derazantinib 300 mg once daily+ atezolizumab 1200 mgPatients 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 |
| Substudy 3: Derazantinib 200 mg twice daily + atezolizumab 1200 mg | Experimental | Drug: Derazantinib 200 mg twice daily + atezolizumab 1200 mgPatients with urothelial cancer were treated with derazantinib 200 mg twice daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion |
| Substudy 4 (Cohort 4a):Derazantinib 300 mg once daily | Experimental | Drug: Derazantinib 300 mg once daily monotherapy (QD)Patients with FGFR inhibitor resistant urothelial cancer were treated with derazantinib 300 mg once daily |
| Substudy 4 (Cohort 4b):Derazantinib 300 mg once daily + atezolizumab 1200 mg | Experimental | Drug: Derazantinib 300 mg once daily + atezolizumab 1200 mgPatients with urothelial cancer were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion |
| Substudy 5: Derazantinib 200 mg twice daily | Experimental | Drug: Derazantinib 200 mg twice daily monotherapyPatients with urothelial cancer were treated with derazantinib 200 mg twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Derazantinib 300 mg once daily monotherapyDerazantinib was administered orally at a dose of 300 mg once daily | Drug | Substudy 1: Derazantinib 300 mg once daily |
| Derazantinib 200 mg once daily + atezolizumab 1200 mgDerazantinib was administered orally at a dose of 200 mg once daily in combination with atezolizumab 1200 mg every 3 weeks | Drug | Substudy 2 (Dose-Level 1): Derazantinib 200 mg once daily + atezolizumab 1200 mg |
| Derazantinib 300 mg once daily+ atezolizumab 1200 mgDerazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks | Drug | Substudy 2 (Dose-Level 2): Derazantinib 300 mg once daily + atezolizumab 1200 mg |
| Derazantinib 200 mg twice daily + atezolizumab 1200 mgDerazantinib was administered orally at a dose of 200 mg twice daily in combination with atezolizumab 1200 mg every 3 weeks | Drug | Substudy 3: Derazantinib 200 mg twice daily + atezolizumab 1200 mg |
| Derazantinib 300 mg once daily monotherapy (QD)Derazantinib was administered orally at a dose of 300 mg once daily | Drug | Substudy 4 (Cohort 4a):Derazantinib 300 mg once daily |
| Derazantinib 300 mg once daily + atezolizumab 1200 mgDerazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks | Drug | Substudy 4 (Cohort 4b):Derazantinib 300 mg once daily + atezolizumab 1200 mg |
| Derazantinib 200 mg twice daily monotherapyDerazantinib was administered orally at a dose of 200 mg twice daily | Drug | Substudy 5: Derazantinib 200 mg twice daily |
Primary outcome
Objective Response Rate (ORR) Based on RECIST 1.1 (Substudies 1,3,4 and 5)
Time frame: From first dose up to 2 years
ORR was defined as the proportion of patients who achieved a confirmed clinical response (CR) or partial response (PR) by blinded investigator central review (BICR) using the internationally recognized criteria for the radiological assessment in tumor response of solid tumors (RECIST) Version 1.1
Recommended Phase 2 Dose (RP2D) of Derazantinib-atezolizumab in Combination Based on DLT Criteria, Safety and Efficacy Data (Substudy 2)
Time frame: From first dose up to 2 years
The RP2D was determined by a joint decision taken by the Independent Data Monitoring Committee (IDMC), Investigators, and the Sponsor in reviewing the aggregate of DLT and AE data, and considering efficacy data
Number of Patients With Dose-limiting Toxicities (DLTs) in Substudy 2
Time frame: From first dose up to 2 years
In Substudy 2, the primary endpoint was the number of patients with DLTs. A DLT was defined as a clinically-significant adverse event (AE) or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications. Any DLT had to be a toxicity considered at least possibly related to derazantinib or the combination of derazantinib and atezolizumab
6 secondary outcomes
Disease Control Rate (DCR) Per RECIST 1.1 in All Substudies
Time frame: From first dose up to 2 years
Duration of Response (DOR) Per RECIST 1.1
Time frame: From first dose up to 2 years
ORR Based on RECIST 1.1 (Substudy 2)
Time frame: From first dose up to 2 years
Progression-free Survival (PFS) by RECIST in All Substudies
Time frame: From first dose up to 2 years
Overall Survival (OS) in All Substudies
Time frame: From first dose up to 2 years
Number of Patients With at Least Grade 3 Adverse Events (AEs)
Time frame: From first dose and until 90 days following the last dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38627238Necchi A, Ramlau R, Falcon Gonzalez A, Chaudhry A, Todenhofer T, Tahbaz R, Fontana E, Giannatempo P, Deville JL, Pouessel D, Yoon S, Powles T, Bernat M, Hackl M, Marszewska M, McKernan P, Saulay M, Scaleia F, Engelhardt M, Loriot Y, Siefker-Radtke A, De Santis M. Derazantinib alone and with atezolizumab in metastatic urothelial carcinoma with activating FGFR aberrations. JNCI Cancer Spectr. 2024 Apr 30;8(3):pkae030. doi: 10.1093/jncics/pkae030.
- Individual participant dataSharing planned: No
Related trials for Urothelial Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
Registry Platform Urologic Cancer
Renal Cell Carcinoma, Urothelial Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel Häckl, MD study director
Basilea Pharmaceutica International Ltd, Allschwil
66 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Derazantinib 300 mg once daily monotherapy, Derazantinib 200 mg once daily + atezolizumab 1200 mg and Derazantinib 300 mg once daily+ atezolizumab 1200 mg in people with Urothelial Carcinoma, run by Basilea Pharmaceutica at 66 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in South Korea, Spain, United States, France, Italy and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) Based on RECIST 1.1 (Substudies 1,3,4 and 5) (time frame: From first dose up to 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04045613, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2023.