Clinical Trials List
Protocol Number20210096
NCT Number(ClinicalTrials.gov Identfier)NCT05052801
2021-12-01 - 2025-01-25
Phase III
Recruiting6
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
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
Amgen Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 張平穎 Division of Hematology & Oncology
- 葉人華 Division of Hematology & Oncology
- 蔡文銓 Division of Others
- 黃子權 Division of Hematology & Oncology
- 賴學緯 Division of Hematology & Oncology
- 陳宇欽 Division of Hematology & Oncology
- 吳宜穎 Division of Hematology & Oncology
- 陳昱光 Division of Hematology & Oncology
- 戴明燊 Division of Hematology & Oncology
- 陳佳宏 Division of Hematology & Oncology
- 翁子恆 Division of Ophthalmology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Che-Hung Lin 無
- 王秀慈 無
- Ching-Chan Lin Division of Hematology & Oncology
- Chang-Fang Chiu 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 黃敬文 無
- Yen-Cheng Chen 無
- 蔡祥麟 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Tsai-Sheng Yang 無
- Ming-Mo Hou 無
- 余紹銘 無
- Wen-Chi Chou 無
- 吳教恩 無
- Chan-Keng Yang Division of Hematology & Oncology
- Wen-Chi Shen 無
- Po-Jung Su 無
- Cheng-Lung Hsu 無
- Hung-Chih Hsu 無
- 黃文冠 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Gastric Cancer,Gastroesophageal Junction Adenocarcinoma
Objectives
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).
Test Drug
Bemarituzumab (AMG 552, FPA144)
Active Ingredient
Bemarituzumab
Dosage Form
Sterile aqueous solution
Dosage
20
Endpoints
Primary Outcome Measures :
Overall Survival (OS) [ Time Frame: Up to approximately 3.5 years ]
Secondary Outcome Measures :
Progression-free Survival (PFS) [ Time Frame: Up to approximately 3.5 years ]
Objective Response Rate (ORR) [ Time Frame: Up to approximately 3.5 years ]
Number of Participants who Experience a Treatment-emergent Adverse Event (TEAE) [ Time Frame: Up to approximately 3.5 years ]
Duration of Response (DOR) [ Time Frame: Up to approximately 3.5 years ]
Disease Control Rate [ Time Frame: Up to approximately 3.5 years ]
Mean Score in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) [ Time Frame: Up to approximately 3.5 years ]
Change from Baseline Score in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) [ Time Frame: Baseline up to approximately 3.5 years ]
Stomach Cancer Related Symptom Mean Score as Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Stomach (EORTC-QLQ-STO22) [ Time Frame: Up to approximately 3.5 years ]
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) [ Time Frame: Baseline up to approximately 3.5 years ]
Mean Score in Visual Analogue Scale (VAS) as Measured by the EuroQol 5-dimensional 5-levels (EQ-5D-5L) [ Time Frame: Up to approximately 3.5 years ]
Change from Baseline of Visual Analogue Scale (VAS) as Measured by the EuroQol 5-dimensional 5-levels (EQ-5D-5L) [ Time Frame: Baseline up to approximately 3.5 years ]
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) [ Time Frame: Up to approximately 3.5 years ]
Time to Deterioration in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) Score [ Time Frame: Up to approximately 3.5 years ]
Time to Deterioration in Visual Analogue Scale (VAS) as Measured by the EuroQol 5-dimensional 5-levels (EQ-5D-5L) Score [ Time Frame: Up to approximately 3.5 years ]
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) [ Time Frame: Day 1 up to approximately 3.5 years ]
Maximum Observed Concentration (Cmax) of Bemarituzumab in Combination with mFOLFOX6 in Plasma [ Time Frame: Day 1 up to approximately 3.5 years ]
Observed Concentration at the End of a Dose Interval (Ctrough) of Bemarituzumab in Combination with mFOLFOX6 in Plasma [ Time Frame: Day 1 up to approximately 3.5 years ]
Number of Participants with an Anti-bemarituzumab Antibody Formation [ Time Frame: Day 1 up to approximately 3.5 years ]
Overall Survival (OS) [ Time Frame: Up to approximately 3.5 years ]
Secondary Outcome Measures :
Progression-free Survival (PFS) [ Time Frame: Up to approximately 3.5 years ]
Objective Response Rate (ORR) [ Time Frame: Up to approximately 3.5 years ]
Number of Participants who Experience a Treatment-emergent Adverse Event (TEAE) [ Time Frame: Up to approximately 3.5 years ]
Duration of Response (DOR) [ Time Frame: Up to approximately 3.5 years ]
Disease Control Rate [ Time Frame: Up to approximately 3.5 years ]
Mean Score in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) [ Time Frame: Up to approximately 3.5 years ]
Change from Baseline Score in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) [ Time Frame: Baseline up to approximately 3.5 years ]
Stomach Cancer Related Symptom Mean Score as Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Stomach (EORTC-QLQ-STO22) [ Time Frame: Up to approximately 3.5 years ]
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) [ Time Frame: Baseline up to approximately 3.5 years ]
Mean Score in Visual Analogue Scale (VAS) as Measured by the EuroQol 5-dimensional 5-levels (EQ-5D-5L) [ Time Frame: Up to approximately 3.5 years ]
Change from Baseline of Visual Analogue Scale (VAS) as Measured by the EuroQol 5-dimensional 5-levels (EQ-5D-5L) [ Time Frame: Baseline up to approximately 3.5 years ]
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) [ Time Frame: Up to approximately 3.5 years ]
Time to Deterioration in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) Score [ Time Frame: Up to approximately 3.5 years ]
Time to Deterioration in Visual Analogue Scale (VAS) as Measured by the EuroQol 5-dimensional 5-levels (EQ-5D-5L) Score [ Time Frame: Up to approximately 3.5 years ]
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) [ Time Frame: Day 1 up to approximately 3.5 years ]
Maximum Observed Concentration (Cmax) of Bemarituzumab in Combination with mFOLFOX6 in Plasma [ Time Frame: Day 1 up to approximately 3.5 years ]
Observed Concentration at the End of a Dose Interval (Ctrough) of Bemarituzumab in Combination with mFOLFOX6 in Plasma [ Time Frame: Day 1 up to approximately 3.5 years ]
Number of Participants with an Anti-bemarituzumab Antibody Formation [ Time Frame: Day 1 up to approximately 3.5 years ]
Inclution Criteria
Inclusion Criteria:
Adults with unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amenable to curative therapy
Fibroblast growth factor receptor 2b (FGFR2b) overexpression positive 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
Adults with unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amenable to curative therapy
Fibroblast growth factor receptor 2b (FGFR2b) overexpression positive 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
Exclusion Criteria
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
Abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer
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
Abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer
The Estimated Number of Participants
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Taiwan
19 participants
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Global
516 participants
