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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05052801




Registration number
NCT05052801
Ethics application status
Date submitted
13/09/2021
Date registered
22/09/2021
Date last updated
13/06/2024

Titles & IDs
Public title
Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression
Scientific title
A Randomized, Multi-center, Double-blind, Placebo-controlled Phase 3 Study of Bemarituzumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer With FGFR2b Overexpression
Secondary ID [1] 0 0
2023-505457-40
Secondary ID [2] 0 0
20210096
Universal Trial Number (UTN)
Trial acronym
FORTITUDE-101
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastric Cancer 0 0
Gastroesophageal Junction Adenocarcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Stomach
Cancer 0 0 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Bemarituzumab
Treatment: Drugs - mFOLFOX6
Treatment: Drugs - Placebo

Experimental: Bemarituzumab with mFOLFOX6 -

Active comparator: Placebo with mFOLFOX6 -


Treatment: Drugs: Bemarituzumab
Intravenous (IV) infusion

Treatment: Drugs: mFOLFOX6
mFOLFOX6 administered as a combination of oxaliplatin and leucovorin as IV infusions. 5-FU administered as bolus followed by additional administration as IV infusion.

Treatment: Drugs: Placebo
IV infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
Up to approximately 3.5 years
Secondary outcome [1] 0 0
Progression-free Survival (PFS)
Timepoint [1] 0 0
Up to approximately 3.5 years
Secondary outcome [2] 0 0
Objective Response Rate (ORR)
Timepoint [2] 0 0
Up to approximately 3.5 years
Secondary outcome [3] 0 0
Number of Participants who Experience a Treatment-emergent Adverse Event (TEAE)
Timepoint [3] 0 0
Up to approximately 3.5 years
Secondary outcome [4] 0 0
Overall Survival
Timepoint [4] 0 0
Up to approximately 3.5 years
Secondary outcome [5] 0 0
Progression-free Survival (PFS)
Timepoint [5] 0 0
Up to approximately 3.5 years
Secondary outcome [6] 0 0
Objective Response Rate (ORR)
Timepoint [6] 0 0
Up to approximately 3.5 years
Secondary outcome [7] 0 0
Duration of Response (DOR)
Timepoint [7] 0 0
Up to approximately 3.5 years
Secondary outcome [8] 0 0
Disease Control Rate
Timepoint [8] 0 0
Up to approximately 3.5 years
Secondary outcome [9] 0 0
Mean Subjective Score in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30)
Timepoint [9] 0 0
Up to approximately 3.5 years
Secondary outcome [10] 0 0
Change from Baseline Score in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30)
Timepoint [10] 0 0
Baseline up to approximately 3.5 years
Secondary outcome [11] 0 0
Stomach Cancer Related Symptom Mean Subjective Score as Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Stomach (EORTC-QLQ-STO22)
Timepoint [11] 0 0
Up to approximately 3.5 years
Secondary outcome [12] 0 0
Change from Baseline in Stomach Cancer Related Symptom Score as Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Stomach (EORTC-QLQ-STO22)
Timepoint [12] 0 0
Baseline up to approximately 3.5 years
Secondary outcome [13] 0 0
Mean Subjective Score in Visual Analogue Scale (VAS) as Measured by the EuroQol 5-dimensional 5-levels (EQ-5D-5L)
Timepoint [13] 0 0
Up to approximately 3.5 years
Secondary outcome [14] 0 0
Change from Baseline of Visual Analogue Scale (VAS) as Measured by the EuroQol 5-dimensional 5-levels (EQ-5D-5L)
Timepoint [14] 0 0
Baseline up to approximately 3.5 years
Secondary outcome [15] 0 0
Time to Deterioration in Stomach Cancer Related Symptom Score as Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Stomach (EORTC-QLQ-STO22)
Timepoint [15] 0 0
Up to approximately 3.5 years
Secondary outcome [16] 0 0
Time to Deterioration in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) Score
Timepoint [16] 0 0
Up to approximately 3.5 years
Secondary outcome [17] 0 0
Time to Deterioration in Visual Analogue Scale (VAS) as Measured by the EuroQol 5-dimensional 5-levels (EQ-5D-5L) Score
Timepoint [17] 0 0
Up to approximately 3.5 years
Secondary outcome [18] 0 0
Time to Deterioration in Physical Function Score as Measured by a Subscale of European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30)
Timepoint [18] 0 0
Day 1 up to approximately 3.5 years
Secondary outcome [19] 0 0
Maximum Observed Concentration (Cmax) of Bemarituzumab in Combination with mFOLFOX6 in Plasma
Timepoint [19] 0 0
Day 1 up to approximately 3.5 years
Secondary outcome [20] 0 0
Observed Concentration at the End of a Dose Interval (Ctrough) of Bemarituzumab in Combination with mFOLFOX6 in Plasma
Timepoint [20] 0 0
Day 1 up to approximately 3.5 years
Secondary outcome [21] 0 0
Number of Participants with an Anti-bemarituzumab Antibody Formation
Timepoint [21] 0 0
Day 1 up to approximately 3.5 years

Eligibility
Key inclusion criteria
* Adults with histologically documented unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amenable to curative therapy
* Fibroblast growth factor receptor 2b (FGFR2b) =10% 2+/3+ tumor cell staining as determined by centrally performed immunohistochemistry (IHC) testing, based on tumor sample either archival (obtained within 6 months/180 days prior to signing pre-screening informed consent) or a fresh biopsy
* Eastern Cooperative Oncology Group (ECOG) less than or equal to 1
* Measurable disease or non-measurable, but evaluable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) V 1.1
* Participant has no contraindications to mFOLFOX6 chemotherapy
* Adequate organ and bone marrow function:

* absolute neutrophil count greater than or equal to 1.5 times 10^9/L
* platelet count greater than or equal to 100 times 10^9/L
* hemoglobin = 9 g/dL without red blood cell (RBC) transfusion within 7 days prior to the first dose of study treatment
* aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 times the upper limit of normal (ULN) (or less than 5 times ULN if liver involvement). Total bilirubin less than 1.5 times ULN (or less than 2 times ULN if liver involvement); with the exception of participants with Gilbert's disease)
* calculated or measured creatinine clearance (CrCl) of = 30 mL/minute calculated using the formula of Cockcroft and Gault ([140 - Age]) × Mass [kg]/[72 × Creatinine mg/dL]) (x 0.85 if female)
* international normalized ratio (INR) or prothrombin time (PT) less than 1.5 times ULN except for participants receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior treatment for metastatic or unresectable disease (Note: prior adjuvant, neo-adjuvant, and peri-operative therapy is allowed if completed more than 6 months prior to first dose of study treatment)
* Prior treatment with any selective inhibitor of fibroblast growth factor - fibroblast growth factor receptor (FGF-FGFR) pathway
* Known human epidermal growth factor receptor 2 (HER2) positive
* Untreated or symptomatic central nervous system (CNS) disease or brain metastases
* Peripheral sensory neuropathy greater than or equal to Grade 2
* Clinically significant cardiac disease
* Other malignancy within the last 2 years (exceptions for definitively treated disease)
* Chronic or systemic ophthalmological disorders
* Major surgery or other investigational study within 28 days prior to first dose of study treatment
* Palliative radiotherapy within 14 days prior to the first dose of study treatment
* Evidence of or recent history (within 6 months) of corneal defects, corneal ulcerations, keratitis, or keratoconus, history of corneal transplant, or other known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer.

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
18/08/2025
Actual
Sample size
Target
516
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
St John of God Murdoch Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alaska
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
South Dakota
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Virginia
Country [13] 0 0
United States of America
State/province [13] 0 0
Washington
Country [14] 0 0
Argentina
State/province [14] 0 0
Buenos Aires
Country [15] 0 0
Argentina
State/province [15] 0 0
Córdoba
Country [16] 0 0
Argentina
State/province [16] 0 0
Santa Fe
Country [17] 0 0
Argentina
State/province [17] 0 0
Tucuman
Country [18] 0 0
Belgium
State/province [18] 0 0
Edegem
Country [19] 0 0
Belgium
State/province [19] 0 0
Gent
Country [20] 0 0
Belgium
State/province [20] 0 0
Leuven
Country [21] 0 0
Belgium
State/province [21] 0 0
Liege
Country [22] 0 0
Brazil
State/province [22] 0 0
Bahia
Country [23] 0 0
Brazil
State/province [23] 0 0
Paraná
Country [24] 0 0
Brazil
State/province [24] 0 0
Rio Grande Do Sul
Country [25] 0 0
Brazil
State/province [25] 0 0
Santa Catarina
Country [26] 0 0
Brazil
State/province [26] 0 0
São Paulo
Country [27] 0 0
Brazil
State/province [27] 0 0
Rio de Janeiro
Country [28] 0 0
Bulgaria
State/province [28] 0 0
Branipole Village
Country [29] 0 0
Bulgaria
State/province [29] 0 0
Haskovo
Country [30] 0 0
Bulgaria
State/province [30] 0 0
Pleven
Country [31] 0 0
Bulgaria
State/province [31] 0 0
Plovdiv
Country [32] 0 0
Bulgaria
State/province [32] 0 0
Sofia
Country [33] 0 0
Canada
State/province [33] 0 0
Alberta
Country [34] 0 0
Canada
State/province [34] 0 0
Ontario
Country [35] 0 0
Canada
State/province [35] 0 0
Quebec
Country [36] 0 0
Chile
State/province [36] 0 0
Cautín
Country [37] 0 0
Chile
State/province [37] 0 0
Santiago
Country [38] 0 0
China
State/province [38] 0 0
Anhui
Country [39] 0 0
China
State/province [39] 0 0
Beijing
Country [40] 0 0
China
State/province [40] 0 0
Chongqing
Country [41] 0 0
China
State/province [41] 0 0
Fujian
Country [42] 0 0
China
State/province [42] 0 0
Gansu
Country [43] 0 0
China
State/province [43] 0 0
Guangdong
Country [44] 0 0
China
State/province [44] 0 0
Hainan
Country [45] 0 0
China
State/province [45] 0 0
Hebei
Country [46] 0 0
China
State/province [46] 0 0
Heilongjiang
Country [47] 0 0
China
State/province [47] 0 0
Henan
Country [48] 0 0
China
State/province [48] 0 0
Hubei
Country [49] 0 0
China
State/province [49] 0 0
Hunan
Country [50] 0 0
China
State/province [50] 0 0
Jiangsu
Country [51] 0 0
China
State/province [51] 0 0
Jiangxi
Country [52] 0 0
China
State/province [52] 0 0
Jilin
Country [53] 0 0
China
State/province [53] 0 0
Liaoning
Country [54] 0 0
China
State/province [54] 0 0
Shaanxi
Country [55] 0 0
China
State/province [55] 0 0
Shandong
Country [56] 0 0
China
State/province [56] 0 0
Shanghai
Country [57] 0 0
China
State/province [57] 0 0
Shanxi
Country [58] 0 0
China
State/province [58] 0 0
Sichuan
Country [59] 0 0
China
State/province [59] 0 0
Zhejiang
Country [60] 0 0
China
State/province [60] 0 0
Tianjin
Country [61] 0 0
Colombia
State/province [61] 0 0
Antioquia
Country [62] 0 0
Colombia
State/province [62] 0 0
Cesar
Country [63] 0 0
Colombia
State/province [63] 0 0
Santander
Country [64] 0 0
Colombia
State/province [64] 0 0
Pasto
Country [65] 0 0
Czechia
State/province [65] 0 0
Brno
Country [66] 0 0
Czechia
State/province [66] 0 0
Hradec Kralove
Country [67] 0 0
Czechia
State/province [67] 0 0
Olomouc
Country [68] 0 0
Czechia
State/province [68] 0 0
Praha 2
Country [69] 0 0
Czechia
State/province [69] 0 0
Praha 4
Country [70] 0 0
Denmark
State/province [70] 0 0
Copenhagen
Country [71] 0 0
Estonia
State/province [71] 0 0
Tallinn
Country [72] 0 0
France
State/province [72] 0 0
Amiens Cedex 1
Country [73] 0 0
France
State/province [73] 0 0
Avignon cedex 9
Country [74] 0 0
France
State/province [74] 0 0
Besançon
Country [75] 0 0
France
State/province [75] 0 0
Brest
Country [76] 0 0
France
State/province [76] 0 0
Clermont-Ferrand cedex 1
Country [77] 0 0
France
State/province [77] 0 0
Lille
Country [78] 0 0
France
State/province [78] 0 0
Lyon cedex 8
Country [79] 0 0
France
State/province [79] 0 0
Paris Cedex 14
Country [80] 0 0
France
State/province [80] 0 0
Paris
Country [81] 0 0
France
State/province [81] 0 0
Reims Cedex
Country [82] 0 0
France
State/province [82] 0 0
Saint Priest en Jarez
Country [83] 0 0
France
State/province [83] 0 0
Strasbourg cedex
Country [84] 0 0
France
State/province [84] 0 0
Villejuif
Country [85] 0 0
Greece
State/province [85] 0 0
Athens
Country [86] 0 0
Greece
State/province [86] 0 0
Heraklion - Crete
Country [87] 0 0
Greece
State/province [87] 0 0
Larissa
Country [88] 0 0
Greece
State/province [88] 0 0
Patra
Country [89] 0 0
Greece
State/province [89] 0 0
Thessaloniki
Country [90] 0 0
Hungary
State/province [90] 0 0
Gyor
Country [91] 0 0
Hungary
State/province [91] 0 0
Gyula
Country [92] 0 0
Hungary
State/province [92] 0 0
Miskolc
Country [93] 0 0
Hungary
State/province [93] 0 0
Nyiregyhaza
Country [94] 0 0
Hungary
State/province [94] 0 0
Szekszard
Country [95] 0 0
Ireland
State/province [95] 0 0
Dublin 4
Country [96] 0 0
Ireland
State/province [96] 0 0
Dublin
Country [97] 0 0
Israel
State/province [97] 0 0
Jerusalem
Country [98] 0 0
Israel
State/province [98] 0 0
Kfar Saba
Country [99] 0 0
Italy
State/province [99] 0 0
Brescia
Country [100] 0 0
Italy
State/province [100] 0 0
Catania
Country [101] 0 0
Italy
State/province [101] 0 0
Lecce
Country [102] 0 0
Italy
State/province [102] 0 0
Milano
Country [103] 0 0
Italy
State/province [103] 0 0
Monserrato CA
Country [104] 0 0
Italy
State/province [104] 0 0
Reggio Emilia
Country [105] 0 0
Italy
State/province [105] 0 0
Roma
Country [106] 0 0
Italy
State/province [106] 0 0
Rozzano MI
Country [107] 0 0
Italy
State/province [107] 0 0
Torino
Country [108] 0 0
Italy
State/province [108] 0 0
Tricase
Country [109] 0 0
Italy
State/province [109] 0 0
Udine
Country [110] 0 0
Italy
State/province [110] 0 0
Verona
Country [111] 0 0
Japan
State/province [111] 0 0
Aichi
Country [112] 0 0
Japan
State/province [112] 0 0
Chiba
Country [113] 0 0
Japan
State/province [113] 0 0
Ehime
Country [114] 0 0
Japan
State/province [114] 0 0
Fukuoka
Country [115] 0 0
Japan
State/province [115] 0 0
Gifu
Country [116] 0 0
Japan
State/province [116] 0 0
Hokkaido
Country [117] 0 0
Japan
State/province [117] 0 0
Hyogo
Country [118] 0 0
Japan
State/province [118] 0 0
Ishikawa
Country [119] 0 0
Japan
State/province [119] 0 0
Kagawa
Country [120] 0 0
Japan
State/province [120] 0 0
Kanagawa
Country [121] 0 0
Japan
State/province [121] 0 0
Kyoto
Country [122] 0 0
Japan
State/province [122] 0 0
Niigata
Country [123] 0 0
Japan
State/province [123] 0 0
Osaka
Country [124] 0 0
Japan
State/province [124] 0 0
Saitama
Country [125] 0 0
Japan
State/province [125] 0 0
Shizuoka
Country [126] 0 0
Japan
State/province [126] 0 0
Tokyo
Country [127] 0 0
Korea, Republic of
State/province [127] 0 0
Busan
Country [128] 0 0
Korea, Republic of
State/province [128] 0 0
Daegu
Country [129] 0 0
Korea, Republic of
State/province [129] 0 0
Daejeon
Country [130] 0 0
Korea, Republic of
State/province [130] 0 0
Goyang-si Gyeonggi-do
Country [131] 0 0
Korea, Republic of
State/province [131] 0 0
Incheon
Country [132] 0 0
Korea, Republic of
State/province [132] 0 0
Jeonju-si, Jeollabuk-do
Country [133] 0 0
Korea, Republic of
State/province [133] 0 0
Seongnam-si, Gyeonggi-do
Country [134] 0 0
Korea, Republic of
State/province [134] 0 0
Seoul
Country [135] 0 0
Latvia
State/province [135] 0 0
Riga
Country [136] 0 0
Lithuania
State/province [136] 0 0
Kaunas
Country [137] 0 0
Lithuania
State/province [137] 0 0
Klaipeda
Country [138] 0 0
Lithuania
State/province [138] 0 0
Vilnius
Country [139] 0 0
Malaysia
State/province [139] 0 0
Sarawak
Country [140] 0 0
Malaysia
State/province [140] 0 0
Wilayah Persekutuan
Country [141] 0 0
Mexico
State/province [141] 0 0
Baja California Norte
Country [142] 0 0
Mexico
State/province [142] 0 0
Jalisco
Country [143] 0 0
Mexico
State/province [143] 0 0
Nuevo León
Country [144] 0 0
Mexico
State/province [144] 0 0
Aguascalientes
Country [145] 0 0
Mexico
State/province [145] 0 0
Mexico
Country [146] 0 0
Norway
State/province [146] 0 0
Oslo
Country [147] 0 0
Peru
State/province [147] 0 0
La Libertad
Country [148] 0 0
Peru
State/province [148] 0 0
Lima
Country [149] 0 0
Peru
State/province [149] 0 0
Arequipa
Country [150] 0 0
Poland
State/province [150] 0 0
Bydgoszcz
Country [151] 0 0
Poland
State/province [151] 0 0
Gdynia
Country [152] 0 0
Poland
State/province [152] 0 0
Jozefow
Country [153] 0 0
Poland
State/province [153] 0 0
Koszalin
Country [154] 0 0
Poland
State/province [154] 0 0
Olsztyn
Country [155] 0 0
Poland
State/province [155] 0 0
Opole
Country [156] 0 0
Poland
State/province [156] 0 0
Poznan
Country [157] 0 0
Poland
State/province [157] 0 0
Przemysl
Country [158] 0 0
Poland
State/province [158] 0 0
Radom
Country [159] 0 0
Portugal
State/province [159] 0 0
Coimbra
Country [160] 0 0
Portugal
State/province [160] 0 0
Guimaraes
Country [161] 0 0
Portugal
State/province [161] 0 0
Lisboa
Country [162] 0 0
Portugal
State/province [162] 0 0
Porto
Country [163] 0 0
Portugal
State/province [163] 0 0
Santa Maria da Feira
Country [164] 0 0
Romania
State/province [164] 0 0
Baia Mare
Country [165] 0 0
Romania
State/province [165] 0 0
Bucharest
Country [166] 0 0
Romania
State/province [166] 0 0
Bucuresti
Country [167] 0 0
Romania
State/province [167] 0 0
Cluj-Napoca
Country [168] 0 0
Romania
State/province [168] 0 0
Iasi
Country [169] 0 0
Romania
State/province [169] 0 0
Ovidiu
Country [170] 0 0
Singapore
State/province [170] 0 0
Singapore
Country [171] 0 0
South Africa
State/province [171] 0 0
Durban
Country [172] 0 0
South Africa
State/province [172] 0 0
Gauteng
Country [173] 0 0
South Africa
State/province [173] 0 0
Johannesburg
Country [174] 0 0
South Africa
State/province [174] 0 0
Tshwane
Country [175] 0 0
Spain
State/province [175] 0 0
Andalucía
Country [176] 0 0
Spain
State/province [176] 0 0
Aragón
Country [177] 0 0
Spain
State/province [177] 0 0
Castilla León
Country [178] 0 0
Spain
State/province [178] 0 0
Cataluña
Country [179] 0 0
Spain
State/province [179] 0 0
Comunidad Valenciana
Country [180] 0 0
Spain
State/province [180] 0 0
Galicia
Country [181] 0 0
Spain
State/province [181] 0 0
País Vasco
Country [182] 0 0
Spain
State/province [182] 0 0
Madrid
Country [183] 0 0
Spain
State/province [183] 0 0
Murcia
Country [184] 0 0
Sweden
State/province [184] 0 0
Göteborg
Country [185] 0 0
Sweden
State/province [185] 0 0
Stockholm
Country [186] 0 0
Sweden
State/province [186] 0 0
Umea
Country [187] 0 0
Taiwan
State/province [187] 0 0
Kaohsiung
Country [188] 0 0
Taiwan
State/province [188] 0 0
Taichung
Country [189] 0 0
Taiwan
State/province [189] 0 0
Tainan
Country [190] 0 0
Taiwan
State/province [190] 0 0
Taipei
Country [191] 0 0
Taiwan
State/province [191] 0 0
Taoyuan
Country [192] 0 0
Thailand
State/province [192] 0 0
Bangkok
Country [193] 0 0
Turkey
State/province [193] 0 0
Adana
Country [194] 0 0
Turkey
State/province [194] 0 0
Ankara
Country [195] 0 0
Turkey
State/province [195] 0 0
Antalya
Country [196] 0 0
Turkey
State/province [196] 0 0
Diyarbakir
Country [197] 0 0
Turkey
State/province [197] 0 0
Istanbul
Country [198] 0 0
Turkey
State/province [198] 0 0
Izmir
Country [199] 0 0
Turkey
State/province [199] 0 0
Kocaeli
Country [200] 0 0
Turkey
State/province [200] 0 0
Malatya
Country [201] 0 0
Turkey
State/province [201] 0 0
Sakarya
Country [202] 0 0
Turkey
State/province [202] 0 0
Samsun
Country [203] 0 0
Turkey
State/province [203] 0 0
Van

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Zai Lab (China only)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The main objective of this study is to compare efficacy of bemarituzumab combined with oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS) in participants with FGFR2b =10% 2+/3+ tumor cell staining (FGFR2b =10% 2+/3+TC)
Trial website
https://clinicaltrials.gov/study/NCT05052801
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amgen Call Center
Address 0 0
Country 0 0
Phone 0 0
866-572-6436
Fax 0 0
Email 0 0
medinfo@amgen.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05052801