A Randomized, Open-label, Japan-Korea 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
20 Years
N/A
Both
Gastric Cancer, Gastroesophageal Junction Cancer
Trial Information
A Randomized, Open-label, Japan-Korea 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
This randomized, open-label, Japan and Korea 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.
Inclusion Criteria:
1. Advanced or recurrent subjects with gastric or gastroesophageal junction
adenocarcinoma.
2. 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.
3. Subjects with EGFR overexpression (2+ or 3+ in IHC)
Exclusion Criteria:
1. Subjects who have received irinotecan
2. Subjects who have received EGFR-directed therapy
3. Other active malignancy within the last 5 years
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Survival
Outcome Description:
Overall survival is defined as the time from the date of randomization to the date of the death from any cause.
Outcome Time Frame:
Around 4.5 years after first subject randomization
Safety Issue:
No
Authority:
Japan: Pharmaceuticals and Medical Devices Agency
Study ID:
DE766-A-J302
NCT ID:
NCT01813253
Start Date:
March 2013
Completion Date:
January 2018
Related Keywords:
- Gastric Cancer
- Gastroesophageal Junction Cancer
- epidermal growth factor receptor
- second line
- Stomach Neoplasms
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