Phase 3 Study of Nimotuzumab and Irinotecan as Second Line With Advanced or Recurrect Gastric and Gastroesophageal Junction Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized, Open-label, Japan-Korea-Taiwan Collaborative Phase 3 Study to Compare the Efficacy of Nimotuzumab and Irinotecan Combination Therapy Versus Irinotecan Monotherapy as Second Line Treatment in Subjects With Advanced or Recurrent Gastric and Gastroesophageal Junction Cancer

Conditions
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Gastric Cancer, Gastroesophageal Junction Cancer

Intervention / Treatment
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* Drug: Irinotecan
* Drug: Nimotuzumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Advanced or recurrent subjects with gastric or gastroesophageal junction adenocarcinoma. Subjects who experienced disease progression during first line or within 6 months after the last dose of first line therapy. The first line regimen must have contained a 5-fluorouracil based agent and platinum agent. Subjects with EGFR overexpression (2+ or 3+ in IHC) Exclusion Criteria: Subjects who have received irinotecan Subjects who have received EGFR-directed therapy Other active malignancy within the last 5 years

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Irinotecan and nimotuzumab<br>Adminitration of irinotecan 150 mg/m2 IV once every 2 weeks and nimotuzumab 400 mg IV once weekly | Drug: Irinotecan<br>* 150 mg/m2 IV once every 2 weeks until progression or unacceptable toxicity develops<br>* Other names: Boryung irinotecan;Drug: Nimotuzumab<br>* 400mg IV once weekly until progression or unacceptable toxicity develops<br>* Other names: DE-766;|
| Active Comparator: Irinotecan<br>Administration of irinotecan 150 mg/m2 IV once every 2 weeks | Drug: Irinotecan<br>* 150 mg/m2 IV once every 2 weeks until progression or unacceptable toxicity develops<br>* Other names: Boryung irinotecan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Overall survival is defined as the time from the date of randomization to the date of the death from any cause. | Around 4.5 years after first subject randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Around 4.5 years after first subject randomization | 
| Incidence of adverse events | Incidence of adverse events using latest CTCAE version 4 including minor version | Around 4.5 years after first subject randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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second line, epidermal growth factor receptor