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

Kuhnil Pharmaceutical

Status and phase: Terminated; Phase 3

Conditions: Gastroesophageal Junction Cancer; Gastric Cancer

Treatments: Drug: Nimotuzumab; Drug: Irinotecan

Study type: Interventional

Funder types: Industry

Identifiers

NCT01813253

DE766-A-J302

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 400 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Irinotecan and nimotuzumab

Experimental group

Description:

Adminitration of irinotecan 150 mg/m2 IV once every 2 weeks and nimotuzumab 400 mg IV once weekly

Treatment:

Drug: Irinotecan

Drug: Nimotuzumab

Irinotecan

Active Comparator group

Description:

Administration of irinotecan 150 mg/m2 IV once every 2 weeks

Treatment:

Drug: Irinotecan