Sonntag, 18. April 2021
Navigation öffnen
Anzeige:
Lonsurf
 
JOURNAL ONKOLOGIE – STUDIE
FIDES-02

Derazantinib and Atezolizumab in Patients With Urothelial Cancer

Rekrutierend

NCT-Nummer:
NCT04045613

Studienbeginn:
Juli 2019

Letztes Update:
25.03.2021

Wirkstoff:
Derazantinib, Atezolizumab (drug supplied by Hoffmann-La Roche)

Indikation (Clinical Trials):
Carcinoma, Transitional Cell

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Basilea Pharmaceutica

Collaborator:
-

Studienleiter

Frédérique Cantero, MD
Study Director
Basilea Pharmaceutica International Ltd

Kontakt

Studienlocations
(3 von 68)

Universitaetsklinikum Carl Gustav Carus
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Studienpraxis Urologie
72622 Nürtingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
University Cancer and Blood Center
30607 Athens
United StatesRekrutierend» Google-Maps
CTCA Clinical Research Inc., Atlanta
30265 Newnan
United StatesRekrutierend» Google-Maps
Midwestern Regional Medical Center, Inc. DBA CTCA, Chicago
60099 Zion
United StatesRekrutierend» Google-Maps
Norton Cancer Institute, Norton Healthcare Pavilion
40202 Louisville
United StatesRekrutierend» Google-Maps
Englander Institute Weill Cornell Medicine
10021 New York
United StatesRekrutierend» Google-Maps
New York Cancer and Blood Specialists
11776 Port Jefferson Station
United StatesRekrutierend» Google-Maps
Greenville Health System - Prisma Health Cancer Institute
29605 Greenville
United StatesRekrutierend» Google-Maps
University of Texas Southwestern Medical Center (UTSWMC)
75390-8852 Dallas
United StatesRekrutierend» Google-Maps
University of Virginia Health System
22908 Charlottesville
United StatesRekrutierend» Google-Maps
Medical Oncology Associates PS (dba Summit Cancer Centers)
99208 Spokane
United StatesRekrutierend» Google-Maps
Ballarat Oncology & Haematology Services
3355 Wendouree
AustraliaRekrutierend» Google-Maps
Ordensklinikum Linz GmbH Elisabethinen
4020 Linz
AustriaRekrutierend» Google-Maps
Krankenhaus Barmherzige Brüder Wien
1020 Vienna
AustriaRekrutierend» Google-Maps
Universitair Ziekenhuis Brussel
1090 Jette
BelgiumRekrutierend» Google-Maps
CHA Centre Hospitalier de l'Ardenne
6800 Libramont
BelgiumRekrutierend» Google-Maps
Fakultni nemocnice u sv. Anny v Brne
61700 Brno
CzechiaRekrutierend» Google-Maps
Medical Oncology - Pitié-Salpêtrière Hopital
75030 Paris
FranceRekrutierend» Google-Maps
National Institute of Oncology
1122 Budapest
HungaryRekrutierend» Google-Maps
Bacs- Kiskun Megyei Korhaz
6000 Kecskemét
HungaryRekrutierend» Google-Maps
B.A.Z.Megyei Központi Kórház és Egyetemi Oktató Kórház
3526 Miskolc
HungaryRekrutierend» Google-Maps
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
20122 Milano
ItalyRekrutierend» Google-Maps
Fondazione IRCCS Istituto Nazionale dei Tumori
20133 Milano
ItalyRekrutierend» Google-Maps
IRCCS - Istituto Europeo di Oncologia IEO
20141 Milano
ItalyRekrutierend» Google-Maps
Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
53100 Siena
ItalyRekrutierend» Google-Maps
ASST Valtellina e Alto Lario - UOC Oncologia Medica Ospedale di Sondrio
23100 Sondrio
ItalyRekrutierend» Google-Maps
Inje University Haeundae Paik Hospital
48108 Busan
Korea, Republic ofRekrutierend» Google-Maps
Pusan National University Hospital
49241 Busan
Korea, Republic ofRekrutierend» Google-Maps
Chungnam National University Hospital
35105 Daejeon
Korea, Republic ofRekrutierend» Google-Maps
National Cancer Center
10408 Goyang-si
Korea, Republic ofRekrutierend» Google-Maps
Gachon University Gil Medical Center
21565 Incheon
Korea, Republic ofRekrutierend» Google-Maps
Seoul National University Bundang Hospital
13620 Seongnam-si
Korea, Republic ofRekrutierend» Google-Maps
Korea University Anam Hospital
02841 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Seoul National University Hospital
110-744 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Yonsei University Health System
3722 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Seoul St. Marys Hospital Catholic University of Korea
6591 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego
20-718 Lublin
PolandRekrutierend» Google-Maps
Mazowiecki Szpital Onkologiczny
05-135 Wieliszew
PolandRekrutierend» Google-Maps
Hospital Universitario HM Sanchinarro CIOCC
28050 Madrid
SpainRekrutierend» Google-Maps
Marques de Valdecilla University Hospital
39011 Santander
SpainRekrutierend» Google-Maps
Hospital Universitario Virgen Macarena
14009 Sevilla
SpainRekrutierend» Google-Maps
Hospital Universitario Virgen del Rocio
41013 Sevilla
SpainRekrutierend» Google-Maps
Barts and The London School of Medicine and Dentistry - Barts Cancer Institute (BCI)
EC1M 6BQ London
United KingdomRekrutierend» Google-Maps
The Sarah Cannon Research Institute
W1G 6AD London
United KingdomRekrutierend» Google-Maps
The Royal Marsden NHS Foundation Trust
SM2 5PT Sutton
United KingdomRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

- 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 clinically significant corneal or retinal disorder

- Phosphatemia greater than institutional upper limit of normal (ULN) at screening

- Uncontrolled tumor-related hypercalcemia

Studien-Rationale

Primary outcome:

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:

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)

Studien-Arme

  • Experimental: Derazantinib [Substudy 1]
    Patients with urothelial cancer who have progressed on at least one line of standard treatment will be treated with derazantinib.
  • 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 randomized for first-line treatment with either derazantinib alone or the recommended phase 2 dose (RP2D) for derazantinib-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 the RP2D for derazantinib-atezolizumab.

Geprüfte Regime

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

Quelle: ClinicalTrials.gov


Das könnte Sie auch interessieren
Primäre Studienendpunkte: Gesamtüberleben oder progressionsfreies Überleben - gibt es einen Goldstandard?

Anerkanntes Ziel einer Therapie von Krebspatienten ist die Verbesserung des Überlebens und der Lebensqualität. Historisch gesehen gilt die Gesamtüberlebenszeit (OS = overall survival) als der wichtigste primäre klinische Endpunkt einer Studie. Doch das Gesamtüberleben als primärer Studienendpunkt unterliegt nicht zuletzt aufgrund der Fortschritte, die in letzten Jahren in der Krebstherapie erzielt wurden,...