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Imfinzi NSCLC
Imfinzi NSCLC
JOURNAL ONKOLOGIE – STUDIE
FIDES-03

Derazantinib Alone or in Combination With Paclitaxel, Ramucirumab or Atezolizumab in Gastric Adenocarcinoma

Rekrutierend

NCT-Nummer:
NCT04604132

Studienbeginn:
Oktober 2020

Letztes Update:
07.05.2021

Wirkstoff:
Derazantinib, Derazantinib-paclitaxel-ramucirumab, Derazantinib-atezolizumab, Paclitaxel-ramucirumab

Indikation (Clinical Trials):
Adenocarcinoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Basilea Pharmaceutica

Collaborator:
-

Studienleiter

Inessa Polyakova, MD
Study Director
Basilea Pharmaceutica International Ltd

Kontakt

Studienlocations
(3 von 63)

Krankenhaus Nordwest GmbH
60488 Frankfurt
(Hessen)
GermanyRekrutierend» Google-Maps
Banner MD Anderson Cancer Center
85234 Gilbert
United StatesRekrutierend» Google-Maps
AdventHealth Cancer Institute
32806 Orlando
United StatesRekrutierend» Google-Maps
Winship Cancer Institute
30322 Atlanta
United StatesRekrutierend» Google-Maps
Monash Medical Centre Clayton
3168 Clayton
AustraliaRekrutierend» Google-Maps
Peter MacCallum Cancer Centre
3000 Melbourne
AustraliaRekrutierend» Google-Maps
Fundação Doutor Amaral Carvalho
17210-120 Jaú
BrazilRekrutierend» Google-Maps
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
09060-870 Santo André
BrazilRekrutierend» Google-Maps
Fundação Faculdade Regional de Medicina de São José do Rio Preto
15090-000 São José Do Rio Preto
BrazilRekrutierend» Google-Maps
CHU Besançon - Hôpital Jean Minjoz
25030 Besancon
FranceRekrutierend» Google-Maps
Centre Georges François Leclerc
21079 Dijon
FranceRekrutierend» Google-Maps
Azienda Ospedaliero Universitaria Mater Domini
88100 Catanzaro
ItalyRekrutierend» Google-Maps
IEO Istituto Europeo di Oncologia
20141 Milano
ItalyRekrutierend» Google-Maps
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
20162 Milano
ItalyRekrutierend» Google-Maps
IOV - Istituto Oncologico Veneto IRCCS
35128 Padova
ItalyRekrutierend» Google-Maps
A.O.U. Senese Policlinico Santa Maria alle Scotte
53100 Siena
ItalyRekrutierend» Google-Maps
National Cancer Center
10408 Goyang-si
Korea, Republic ofRekrutierend» Google-Maps
Chonnam National University Hwasun Hospital
58128 Hwasun-gun
Korea, Republic ofRekrutierend» Google-Maps
Seoul National University Bundang Hospital
13620 Seongnam
Korea, Republic ofRekrutierend» Google-Maps
Seoul National University Hospital
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Asan Medical Center
05505 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Samsung Medical Center
06351 Seoul
Korea, Republic ofRekrutierend» Google-Maps
The Catholic University of Korea, Seoul St. Mary's Hospital
06591 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Ajou University Hospital
16499 Suwon
Korea, Republic ofRekrutierend» Google-Maps
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
02-781 Warszawa
PolandRekrutierend» Google-Maps
Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna
90-242 Łódź
PolandRekrutierend» Google-Maps
SAIH "Republican Clinical Oncological Dispensary of the Ministry of Healthcare of Republic Tatarstan
420029 Kazan
Russian FederationRekrutierend» Google-Maps
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
115478 Moscow
Russian FederationRekrutierend» Google-Maps
BHI of Omsk region "Clinical Oncology Dispensary"
644013 Omsk
Russian FederationRekrutierend» Google-Maps
FSBI "Clinical Research and Practical Center for specialized medical care (oncology)"
197758 Pesochnyy
Russian FederationRekrutierend» Google-Maps
Pavlov First Saint Petersburg State Medical University
197022 Saint Petersburg
Russian FederationRekrutierend» Google-Maps
FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"
197758 Saint Petersburg
Russian FederationRekrutierend» Google-Maps
SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan
450054 Ufa
Russian FederationRekrutierend» Google-Maps
Hospital Universitari Vall d'Hebron
08035 Barcelona
SpainRekrutierend» Google-Maps
Hospital Clinic de Barcelona
08036 Barcelona
SpainRekrutierend» Google-Maps
Hospital Universitario Ramon y Cajal
28034 Madrid
SpainRekrutierend» Google-Maps
Centro Integral Oncologico Clara Campal
28050 Madrid
SpainRekrutierend» Google-Maps
Clinica Universidad de Navarra
31008 Pamplona
SpainRekrutierend» Google-Maps
Hacettepe University Medical Faculty
06100 Ankara
TurkeyRekrutierend» Google-Maps
Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital
06105 Ankara
TurkeyRekrutierend» Google-Maps
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
34098 Istanbul
TurkeyRekrutierend» Google-Maps
Istanbul Medeniyet Uni Goztepe Training&Res Hosp
34854 Istanbul
TurkeyRekrutierend» Google-Maps
Kocaeli Universitesi Tip Fakultesi
41380 Kocaeli
TurkeyRekrutierend» Google-Maps
Addenbrooke's Hospital
CB2 0QQ Cambridge
United KingdomRekrutierend» Google-Maps
Beatson West of Scotland Cancer Centre
G12 OYN Glasgow
United KingdomRekrutierend» Google-Maps
University College London Hospitals
W1T7HA London
United KingdomRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

The study comprises three open-label substudies in patients with HER2-negative adenocarcinoma

of the stomach or gastro-esophageal junction harboring FGFR2 gene translocations, FGFR2 gene

amplifications, or FGFR1-3 mutations. Patients will be treated with single-agent derazantinib

or derazantinib in combination with paclitaxel, ramucirumab, or atezolizumab. The study

enrolls patients with either metastatic or recurrent locally advanced HER2-negative

adenocarcinoma of the stomach or gastro-esophageal junction inoperable at the time of

screening, and radiologically confirmed disease progression after one or at least one

standard treatment regimen.

Ein-/Ausschlusskriterien

Key Inclusion Criteria:

- Histologically-confirmed adenocarcinoma of the gastro-esophageal junction or stomach

- Male or female aged ≥ 18 years

- Negative HER2 status obtained from the most recent available tissue sample

- Inoperable recurrent, locally advanced adenocarcinoma or progressing stage IV

adenocarcinoma of the gastro-esophageal junction or stomach, and disease progression

after either standard first- or second-line treatment (Substudy 1), or after standard

first-line treatment (Substudies 2 and 3)

- Positive test for eligible FGFR aberrations

- For Substudies 1 and 3, measurable disease as defined by the Investigator using RECIST

1.1 criteria

- ECOG PS of 0 or 1

- Men and women of childbearing potential must agree to avoid impregnating a partner or

becoming pregnant, respectively, during the study, and for at least 150 days after the

last dose of either investigational drug

Key Exclusion Criteria:

- Prior anticancer or investigational drug treatment within an interval shorter than the

following, as applicable:

1. One chemotherapy or biological (e.g., antibody) cycle interval

2. Five half-lives of any small molecule investigational or licensed medicinal

product

3. Two weeks, for any investigational medicinal product with an unknown half-life

4. Four weeks of curative radiotherapy

5. Seven days of palliative radiotherapy

6. 28 days of radiotherapy

- Prior treatment with FGFR Inhibitors (all substudies), and prior treatment with

taxanes within 6 months prior to randomization and/or anti-VEGF(R) therapeutic

antibody or pathway-targeting agents (Substudies 2 and 3), and prior treatment with

anti-programmed cell death receptor-1 (PD-1) or anti-programmed death ligand-1 (PD-L1)

therapeutic antibody or pathway-targeting agents (Substudy 3)

- Concurrent evidence of clinically significant corneal or retinal disorder

- History of clinically significant cardiac disorders and/or a QT interval corrected by

Fridericia's formula (QTcF) > 450 ms for males or > 460 ms for females

- For Substudies 1 and 3, known CNS metastases

- Concurrent uncontrolled or active infection with human immunodeficiency virus (HIV;

known HIV 1/2 antibodies positive); active hepatitis B virus (HBV) and hepatitis C

virus (HCV) co-infection; active tuberculosis (for Substudies 2 and 3)

- Child-Pugh B or C liver cirrhosis, or a history of hepatic encephalopathy, hepatorenal

syndrome, or clinically-meaningful ascites related to cirrhosis (for Substudies 2 and

3)

- Administration of a live, attenuated vaccine within 30 days prior to randomization

(for Substudy 3)

- Treatment with systemic corticosteroids (except for steroidal replacement therapy) or

other systemic immunosuppressive medications within 2 weeks prior to first dose of

study drug or anticipated requirement for systemic immunosuppressive medications

during the study (for Substudy 3)

Studien-Rationale

Primary outcome:

1. Overall response rate (ORR) per RECIST 1.1 (Substudies 1 and 3) (Time Frame - Approximately 30 months):
ORR of will be measured by the proportion of patients with confirmed complete response (CR) or partial response (PR) by blinded independent central review (BICR).

2. Recommended phase 2 dose (RP2D) of derazantinib-paclitaxel-ramucirumab in combination (Substudy 2) (Time Frame - Approximately 8 months):
RP2D will be determined from safety and tolerability according to the aggregate of dose-limiting toxicity criteria and adverse event (AE) data, and considering further pharmacokinetic and efficacy data of the combination.

Secondary outcome:

1. Progression-free Survival (PFS) (Time Frame - Approximately 2 years):
PFS will be measured from patient enrollment to progressive disease (PD) date by BICR

2. Disease Control Rate (DCR) (Time Frame - Approximately 2 years):
Measured by the proportion of patients with confirmed CR, PR or stable disease (SD) by BICR

3. Duration of Response (DOR) (Time Frame - Approximately 2 years):
DOR will be calculated from the first date of documented tumor response to disease progression by BICR (or death if no documentation of PD is obtained)

4. Overall Survival (OS) (Time Frame - Approximately 2 years):
OS will be measured from patient enrollment to time of death

Studien-Arme

  • Experimental: Derazantinib
    In Substudies 1 and 3.1, patients with HER2-negative adenocarcinoma of the stomach or gastro-esophageal junction harboring FGFR genetic aberrations will receive derazantinib.
  • Experimental: Derazantinib-paclitaxel-ramucirumab
    In Substudies 2 and 3.2, patients with HER2-negative adenocarcinoma of the stomach or gastro-esophageal junction harboring FGFR genetic aberrations will receive derazantinib-paclitaxel-ramucirumab in combination.
  • Experimental: Derazantinib-atezolizumab
    In Substudy 3.3, patients with HER2-negative adenocarcinoma of the stomach or gastro-esophageal junction harboring FGFR genetic aberrations will receive derazantinib-atezolizumab in combination.
  • Active Comparator: Standard of care
    In Substudy 3.4, patients with HER2-negative adenocarcinoma of the stomach or gastro-esophageal junction harboring FGFR genetic aberrations will receive the Standard of Care drugs paclitaxel-ramucirumab in combination.

Geprüfte Regime

  • Derazantinib:
    Derazantinib will be administered orally at a dose of 300 mg once a day as monotherapy.
  • Derazantinib-paclitaxel-ramucirumab:
    Derazantinib will be administered at the RP2D for derazantinib-paclitaxel-ramucirumab determined in Substudy 2 in combination with paclitaxel and ramucirumab. Paclitaxel will be administered intravenously at the RP2D for derazantinib-paclitaxel-ramucirumab determined in Substudy 2 on days 1, 8, and 15 of a 28-day cycle in combination with derazantinib and ramucirumab. Ramucirumab will be administered intravenously at the RP2D for derazantinib-paclitaxel-ramucirumab determined in Substudy 2 every 2 weeks in combination with derazantinib and paclitaxel.
  • Derazantinib-atezolizumab:
    Derazantinib will be administered orally at a dose of 300 mg once a day in combination with atezolizumab. Atezolizumab will be administered intravenously at a dose of 1200 mg every 3 weeks in combination with derazantinib.
  • Paclitaxel-ramucirumab:
    Paclitaxel will be administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab. Ramucirumab will be administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.

Quelle: ClinicalTrials.gov


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