search
Back to results

Derazantinib Alone or in Combination With Paclitaxel, Ramucirumab or Atezolizumab in Gastric Adenocarcinoma (FIDES-03)

Primary Purpose

Gastric Adenocarcinoma

Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Derazantinib
Derazantinib-paclitaxel-ramucirumab
Derazantinib-atezolizumab
Paclitaxel-ramucirumab
Sponsored by
Basilea Pharmaceutica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Adenocarcinoma focused on measuring gastric cancer, gastro-esophageal adenocarcinoma, adenocarcinoma of the stomach or gastro-esophageal junction, fibroblast growth factor receptor, FGFR genetic aberration, targeted therapy, derazantinib, atezolizumab, Tecentriq, paclitaxel, ramucirumab, Cyramza, solid tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 (FGFR2 fusions / rearrangements / amplifications; FGFR1, FGFR2, or FGFR3 mutations / short variants)
  • 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
  • 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
  • Known CNS metastases
  • Concurrent uncontrolled or active infection with human immunodeficiency virus (HIV; known HIV 1/2 antibodies positive); active or chronic hepatitis B without current antiviral therapy and an HBV DNA ≥ 100 IU/mL virus (HBV); active 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)

Sites / Locations

  • AdventHealth Cancer Institute
  • Memorial Sloan Kettering Cancer Center
  • Hospital de Gastroenterologia Dr. Carlos Bonorino Udaondo
  • Fundación Favaloro para la Docencia e Investigación Médica
  • Monash Medical Centre Clayton
  • Peter MacCallum Cancer Centre
  • The Alfred Hospital
  • UZA
  • UZ Leuven
  • AZ Delta
  • Liga Norte-Rio-Grandense Contra o Câncer
  • Fundação Doutor Amaral Carvalho
  • Instituto Nacional de Câncer José Alencar Gomes da Silva
  • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
  • Fundação Faculdade Regional de Medicina de São José do Rio Preto
  • CeCim Biocinetic
  • Centro de Estudios Clínicos SAGA
  • Instituto Clinico Oncologico
  • Institut Sainte Catherine
  • CHU Besançon - Hôpital Jean Minjoz
  • Centre Georges François Leclerc
  • Hôpital Saint-Louis
  • Hôpital Saint-Antoine
  • Institut Gustave Roussy
  • Universitaetsklinikum Ulm
  • Medizinische Hochschule Hannover
  • Universitaetsklinikum Carl Gustav Carus TU Dresden
  • Staedtisches Klinikum Dresden Standort Dresden-Friedrichstadt
  • Krankenhaus Nordwest GmbH
  • Uniklinik Mainz
  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
  • Azienda Ospedaliero Universitaria Mater Domini
  • Fondazione IRCCS Istituto Nazionale dei Tumori
  • IEO Istituto Europeo di Oncologia
  • Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
  • IOV - Istituto Oncologico Veneto IRCCS
  • Istituto Clinico Humanitas
  • A.O.U. Senese Policlinico Santa Maria alle Scotte
  • National Cancer Center
  • Chonnam National University Hwasun Hospital
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Asan Medical Center
  • Samsung Medical Center
  • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Ajou University Hospital
  • Examen sp. z o.o.
  • Centrum Zdrowia MDM
  • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
  • Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna
  • SAIH "Republican Clinical Oncological Dispensary of the Ministry of Healthcare of Republic Tatarstan
  • FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
  • "VitaMed" LLC
  • BHI of Omsk region "Clinical Oncology Dispensary"
  • FSBI "Clinical Research and Practical Center for specialized medical care (oncology)"
  • Pavlov First Saint Petersburg State Medical University
  • FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"
  • Tomsk Research Instutite of Oncology
  • SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan
  • Hospital del Mar
  • Hospital Universitari Vall d'Hebron
  • Hospital Clinic de Barcelona
  • ICO l'Hospitalet - Hospital Duran i Reynals
  • MD Anderson Cancer Centre
  • Hospital Universitario Ramon y Cajal
  • Centro Integral Oncologico Clara Campal
  • Clinica Universidad de Navarra
  • Baskent University Adana Application and Research Center
  • Hacettepe University Medical Faculty
  • Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital
  • Ankara City Hospital
  • Akdeniz University Medical Faculty
  • Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
  • Istanbul Medeniyet Uni Goztepe Training&Res Hosp
  • Kocaeli Universitesi Tip Fakultesi
  • Addenbrooke's Hospital
  • Ninewells Hospital
  • Beatson West of Scotland Cancer Centre
  • University College London Hospitals
  • The Christie
  • Royal Marsden Hospital- Sutton

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Derazantinib

Derazantinib-paclitaxel-ramucirumab

Derazantinib-atezolizumab

Standard of care

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Objective response rate (ORR) per RECIST 1.1 in Substudy 1 (in two subgroups Cohort 1.1 and 1.2) and Substudy 3)
ORR will be measured by the proportion of patients with confirmed complete response (CR) or partial response (PR) by blinded independent central review (BICR).
4-month progression-free survival rate (PFS4, in a subgroup (Cohort 1.3) within Substudy 1)
PFS4 will be measured by the proportion of patients alive and free of disease progression by blinded independent central review (BICR) per RECIST. 1.1
Recommended phase 2 dose (RP2D) of derazantinib-paclitaxel-ramucirumab in combination (Substudy 2)
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 Measures

ORR per RECIST 1.1 in subgroup Cohort 1.3 within Substudy 1and in Substudy 3
ORR will be measured by the proportion of patients with confirmed complete response (CR) or partial response (PR) by blinded independent central review (BICR).
Disease Control Rate (DCR)
Measured by the proportion of patients with confirmed CR, PR or stable disease (SD) by BICR
Duration of Response (DOR)
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)
Progression-free Survival (PFS)
PFS will be measured from patient enrollment to progressive disease (PD) date by BICR
Overall Survival (OS)
OS will be measured from patient enrollment to time of death
Pharmacokinetic (PK) profile: Peak Plasma Concentration (Cmax) of derazantinib 200 mg twice daily monotherapy
Derazantinib plasma concentrations including Cmax will be assessed by measurements in plasma samples
Pharmacokinetic (PK) profile: Area under the plasma concentration versus time curve (AUC) of derazantinib 200 mg twice daily monotherapy
AUC will be assessed by measurements of derazantinib in plasma samples
Pharmacokinetic (PK) profile: The time to reach Cmax (Tmax) of derazantinib 200 mg twice daily monotherapy
Tmax will be assessed by measurements of derazantinib in plasma samples

Full Information

First Posted
October 21, 2020
Last Updated
February 14, 2023
Sponsor
Basilea Pharmaceutica
search

1. Study Identification

Unique Protocol Identification Number
NCT04604132
Brief Title
Derazantinib Alone or in Combination With Paclitaxel, Ramucirumab or Atezolizumab in Gastric Adenocarcinoma
Acronym
FIDES-03
Official Title
A Phase 1b/2 Study of Derazantinib as Monotherapy and Combination Therapy With Paclitaxel, Ramucirumab or Atezolizumab in Patients With HER2-negative Gastric Adenocarcinoma Expressing FGFR2 Genetic Aberrations
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
Terminated prematurely for administrative reasons not related to patient safety.
Study Start Date
October 6, 2020 (Actual)
Primary Completion Date
December 29, 2022 (Actual)
Study Completion Date
December 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Basilea Pharmaceutica

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy of derazantinib monotherapy or derazantinib in combination with paclitaxel, ramucirumab, or atezolizumab in patients with HER2-negative adenocarcinoma of the stomach or gastro-esophageal junction harboring FGFR2 genetic aberrations (GA).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Adenocarcinoma
Keywords
gastric cancer, gastro-esophageal adenocarcinoma, adenocarcinoma of the stomach or gastro-esophageal junction, fibroblast growth factor receptor, FGFR genetic aberration, targeted therapy, derazantinib, atezolizumab, Tecentriq, paclitaxel, ramucirumab, Cyramza, solid tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Derazantinib
Arm Type
Experimental
Arm Description
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.
Arm Title
Derazantinib-paclitaxel-ramucirumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Derazantinib-atezolizumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Derazantinib
Intervention Description
Derazantinib will be administered orally at a dose of 300 mg once a day and at a dose of 200 mg twice daily as monotherapy in the Substudy 1.
Intervention Type
Drug
Intervention Name(s)
Derazantinib-paclitaxel-ramucirumab
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Derazantinib-atezolizumab
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel-ramucirumab
Intervention Description
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.
Primary Outcome Measure Information:
Title
Objective response rate (ORR) per RECIST 1.1 in Substudy 1 (in two subgroups Cohort 1.1 and 1.2) and Substudy 3)
Description
ORR will be measured by the proportion of patients with confirmed complete response (CR) or partial response (PR) by blinded independent central review (BICR).
Time Frame
Approximately 30 months
Title
4-month progression-free survival rate (PFS4, in a subgroup (Cohort 1.3) within Substudy 1)
Description
PFS4 will be measured by the proportion of patients alive and free of disease progression by blinded independent central review (BICR) per RECIST. 1.1
Time Frame
Approximately 18 months
Title
Recommended phase 2 dose (RP2D) of derazantinib-paclitaxel-ramucirumab in combination (Substudy 2)
Description
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.
Time Frame
Approximately 18 months
Secondary Outcome Measure Information:
Title
ORR per RECIST 1.1 in subgroup Cohort 1.3 within Substudy 1and in Substudy 3
Description
ORR will be measured by the proportion of patients with confirmed complete response (CR) or partial response (PR) by blinded independent central review (BICR).
Time Frame
Approximately 24 months
Title
Disease Control Rate (DCR)
Description
Measured by the proportion of patients with confirmed CR, PR or stable disease (SD) by BICR
Time Frame
Approximately 24 months
Title
Duration of Response (DOR)
Description
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)
Time Frame
Approximately 24 months
Title
Progression-free Survival (PFS)
Description
PFS will be measured from patient enrollment to progressive disease (PD) date by BICR
Time Frame
Approximately 24 months
Title
Overall Survival (OS)
Description
OS will be measured from patient enrollment to time of death
Time Frame
Approximately 24 months
Title
Pharmacokinetic (PK) profile: Peak Plasma Concentration (Cmax) of derazantinib 200 mg twice daily monotherapy
Description
Derazantinib plasma concentrations including Cmax will be assessed by measurements in plasma samples
Time Frame
Approximately 24 months
Title
Pharmacokinetic (PK) profile: Area under the plasma concentration versus time curve (AUC) of derazantinib 200 mg twice daily monotherapy
Description
AUC will be assessed by measurements of derazantinib in plasma samples
Time Frame
Approximately 24 months
Title
Pharmacokinetic (PK) profile: The time to reach Cmax (Tmax) of derazantinib 200 mg twice daily monotherapy
Description
Tmax will be assessed by measurements of derazantinib in plasma samples
Time Frame
Approximately 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 (FGFR2 fusions / rearrangements / amplifications; FGFR1, FGFR2, or FGFR3 mutations / short variants) 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: One chemotherapy or biological (e.g., antibody) cycle interval Five half-lives of any small molecule investigational or licensed medicinal product Two weeks, for any investigational medicinal product with an unknown half-life Four weeks of curative radiotherapy Seven days of palliative 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 Known CNS metastases Concurrent uncontrolled or active infection with human immunodeficiency virus (HIV; known HIV 1/2 antibodies positive); active or chronic hepatitis B without current antiviral therapy and an HBV DNA ≥ 100 IU/mL virus (HBV); active 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuel Häckl, MD
Organizational Affiliation
Basilea Pharmaceutica International Ltd
Official's Role
Study Director
Facility Information:
Facility Name
AdventHealth Cancer Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Hospital de Gastroenterologia Dr. Carlos Bonorino Udaondo
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
B1264AAA
Country
Argentina
Facility Name
Fundación Favaloro para la Docencia e Investigación Médica
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1093AAS
Country
Argentina
Facility Name
Monash Medical Centre Clayton
City
Clayton
ZIP/Postal Code
3168
Country
Australia
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
ZIP/Postal Code
3000
Country
Australia
Facility Name
The Alfred Hospital
City
Prahran
ZIP/Postal Code
3181
Country
Australia
Facility Name
UZA
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
AZ Delta
City
Menen
ZIP/Postal Code
8930
Country
Belgium
Facility Name
Liga Norte-Rio-Grandense Contra o Câncer
City
Natal
State/Province
Rio Grande Do Norte
ZIP/Postal Code
59075-740
Country
Brazil
Facility Name
Fundação Doutor Amaral Carvalho
City
Jaú
ZIP/Postal Code
17210-120
Country
Brazil
Facility Name
Instituto Nacional de Câncer José Alencar Gomes da Silva
City
Rio De Janeiro
ZIP/Postal Code
20230-230
Country
Brazil
Facility Name
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
City
Santo André
ZIP/Postal Code
09060-870
Country
Brazil
Facility Name
Fundação Faculdade Regional de Medicina de São José do Rio Preto
City
São José Do Rio Preto
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
CeCim Biocinetic
City
Santiago
State/Province
Region Met
ZIP/Postal Code
8331143
Country
Chile
Facility Name
Centro de Estudios Clínicos SAGA
City
Santiago
ZIP/Postal Code
7500000
Country
Chile
Facility Name
Instituto Clinico Oncologico
City
Temuco
ZIP/Postal Code
4810469
Country
Chile
Facility Name
Institut Sainte Catherine
City
Avignon
ZIP/Postal Code
84918
Country
France
Facility Name
CHU Besançon - Hôpital Jean Minjoz
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Centre Georges François Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Hôpital Saint-Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Hôpital Saint-Antoine
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Universitaetsklinikum Ulm
City
Ulm
State/Province
Baden Wuerttemberg
ZIP/Postal Code
89081
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitaetsklinikum Carl Gustav Carus TU Dresden
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
Staedtisches Klinikum Dresden Standort Dresden-Friedrichstadt
City
Dresden
ZIP/Postal Code
01067
Country
Germany
Facility Name
Krankenhaus Nordwest GmbH
City
Frankfurt
ZIP/Postal Code
60488
Country
Germany
Facility Name
Uniklinik Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Mater Domini
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
IEO Istituto Europeo di Oncologia
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
IOV - Istituto Oncologico Veneto IRCCS
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Facility Name
A.O.U. Senese Policlinico Santa Maria alle Scotte
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
National Cancer Center
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Examen sp. z o.o.
City
Skórzewo
ZIP/Postal Code
60-185
Country
Poland
Facility Name
Centrum Zdrowia MDM
City
Warszawa
ZIP/Postal Code
01-401
Country
Poland
Facility Name
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna
City
Łódź
ZIP/Postal Code
90-242
Country
Poland
Facility Name
SAIH "Republican Clinical Oncological Dispensary of the Ministry of Healthcare of Republic Tatarstan
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
"VitaMed" LLC
City
Moscow
ZIP/Postal Code
121309
Country
Russian Federation
Facility Name
BHI of Omsk region "Clinical Oncology Dispensary"
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
FSBI "Clinical Research and Practical Center for specialized medical care (oncology)"
City
Pesochnyy
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Pavlov First Saint Petersburg State Medical University
City
Saint Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"
City
Saint Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Tomsk Research Instutite of Oncology
City
Tomsk
ZIP/Postal Code
634045
Country
Russian Federation
Facility Name
SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan
City
Ufa
ZIP/Postal Code
450054
Country
Russian Federation
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
ICO l'Hospitalet - Hospital Duran i Reynals
City
L'Hospitalet de Llobregat
ZIP/Postal Code
08908
Country
Spain
Facility Name
MD Anderson Cancer Centre
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Centro Integral Oncologico Clara Campal
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Clinica Universidad de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Baskent University Adana Application and Research Center
City
Adana
ZIP/Postal Code
01220
Country
Turkey
Facility Name
Hacettepe University Medical Faculty
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital
City
Ankara
ZIP/Postal Code
06105
Country
Turkey
Facility Name
Ankara City Hospital
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Facility Name
Akdeniz University Medical Faculty
City
Antalya
ZIP/Postal Code
07058
Country
Turkey
Facility Name
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Istanbul Medeniyet Uni Goztepe Training&Res Hosp
City
Istanbul
ZIP/Postal Code
34854
Country
Turkey
Facility Name
Kocaeli Universitesi Tip Fakultesi
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Facility Name
Addenbrooke's Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Ninewells Hospital
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
ZIP/Postal Code
G12 OYN
Country
United Kingdom
Facility Name
University College London Hospitals
City
London
ZIP/Postal Code
W1T7HA
Country
United Kingdom
Facility Name
The Christie
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Royal Marsden Hospital- Sutton
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs