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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

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
Active, not 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
Accrual to date
Final
547
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
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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
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China
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Fujian
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China
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Gansu
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China
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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
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France
State/province [74] 0 0
Besançon
Country [75] 0 0
France
State/province [75] 0 0
Brest Cedex
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
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Poland
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Koszalin
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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
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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
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Portugal
State/province [160] 0 0
Guimaraes
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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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Available to whom?
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.amgen.com/datasharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05052801