Study Complete
Sponsor ID
20210096

Bemarituzumab or Placebo plus Chemotherapy in Gastric Cancers with Fibroblast Growth Factor Receptor 2b (FGFR2b) OverexpressionFORTITUDE-101

Sponsor ID
20210096
Clinicaltrials.gov ID
NCT05052801
EUCTIS ID
2023-505457-40
EudraCT ID
N/A

Study Details

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)

Additional Study Details

Phase
Phase 3
Product
Bemarituzumab
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
547
Additional Study Details

Protocol Summary

Primary Outcome Measures

Overall Survival

Timeframe: Up to approximately 3.5 years

Secondary Outcome Measures

Progression-free Survival (PFS)

Timeframe: Up to approximately 3.5 years

Objective Response Rate (ORR)

Timeframe: Up to approximately 3.5 years

Number of Participants who Experience a Treatment-emergent Adverse Event (TEAE)

Timeframe: Up to approximately 3.5 years

Overall Survival

Timeframe: Up to approximately 3.5 years

Progression-free Survival (PFS)

Timeframe: Up to approximately 3.5 years

Objective Response Rate (ORR)

Timeframe: Up to approximately 3.5 years

Duration of Response (DOR)

Timeframe: Up to approximately 3.5 years

Disease Control Rate

Timeframe: Up to approximately 3.5 years

Mean Subjective Score in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30)

Timeframe: 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)

Timeframe: Baseline up to approximately 3.5 years

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)

Timeframe: 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)

Timeframe: Baseline up to approximately 3.5 years

Mean Subjective Score in Visual Analogue Scale (VAS) as Measured by the EuroQol 5-dimensional 5-levels (EQ-5D-5L)

Timeframe: 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)

Timeframe: 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)

Timeframe: 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

Timeframe: 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

Timeframe: 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)

Timeframe: Day 1 up to approximately 3.5 years

Maximum Observed Concentration (Cmax) of Bemarituzumab in Combination with mFOLFOX6 in Plasma

Timeframe: 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

Timeframe: Day 1 up to approximately 3.5 years

Number of Participants with an Anti-bemarituzumab Antibody Formation

Timeframe: Day 1 up to approximately 3.5 years

Locations

Location
Status
Contact Us
Location
Alaska Oncology and Hematology
Anchorage, AK, United States, 99508
Status
Recruiting
Location
The Oncology Institute Clinical Research
Cerritos, CA, United States, 90703
Status
Recruiting
Location
St John of God Murdoch Hospital
Murdoch, WA, Australia, 6150
Status
Terminated
Location
FirstHealth Cancer Center
Pinehurst, NC, United States, 28374
Status
Recruiting
Location
White Plains Hospital Center for Cancer Care
White Plains, NY, United States, 10601
Status
Recruiting
Location
Nacionalinis vezio institutas
Vilnius, Lithuania, 08660
Status
Recruiting
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