This study will evaluate overall survival of nimotuzumab in combination with irinotecan compared to irinotecan alone in subjects with EGFR overexpressed advanced gastric or gastroesophageal junction cancer.
This randomized, open-label, Japan, Korea and Taiwan collaborative, phase 3 study will evaluate overall survival of nimotuzumab in combination with irinotecan compared to irinotecan alone in subjects with EGFR overexpressed advanced gastric or gastroesophageal junction cancer. Approximately 400 subjects will be randomized in a 1:1 ratio to receive irinotecan (control group) or nimotuzumab and irinotecan (combination group). Nimotuzumab and/or irinotecan should be continued until disease progression or intolerable toxicity. Nimotuzumab is administered at 400 mg once weekly as an intravenous infusion and irinotecan is administered at 150 mg/m2 once every 2 weeks as an intravenous infusion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
150 mg/m2 IV once every 2 weeks until progression or unacceptable toxicity develops
400mg IV once weekly until progression or unacceptable toxicity develops
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Overall Survival
Overall survival is defined as the time from the date of randomization to the date of the death from any cause.
Time frame: Around 4.5 years after first subject randomization
Progression Free Survival
Progression Free Survival is defined as the time from the date of randomization to the date of progression or death from any cause, whichever comes first.
Time frame: Around 4.5 years after first subject randomization
Overall Response Rate
Overall Response Rate is defined as the proportion of subjects with CR or PR in the best overall response.
Time frame: Around 4.5 years after first subject randomization
Disease Control Rate
Disease Control Rate is defined as the proportion of subjects with CR, PR or SD in the best overall response.
Time frame: Around 4.5 years after first subject randomization
Incidence of adverse events
Incidence of adverse events using latest CTCAE version 4 including minor version
Time frame: Around 4.5 years after first subject randomization
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Aichi, Japan
Unnamed facility
Akita, Japan
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Aomori, Japan
Unnamed facility
Chiba, Japan
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Ehime, Japan
Unnamed facility
Fukuoka, Japan
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Hiroshima, Japan
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Hokkaido, Japan
Unnamed facility
Hyōgo, Japan
...and 27 more locations