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

Phase 3

Terminated

• Conditions: Gastroesophageal Junction Cancer; Gastric Cancer
• Interventions: Drug: Irinotecan; Drug: Nimotuzumab

• Registration Number: NCT01813253
• Lead Sponsor: Kuhnil Pharmaceutical Co., Ltd.

Brief Summary

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

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 Timeline

• Study First Submitted: 2013-03-11
• Study First Submitted QC: 2013-03-13
• Study First Posted: 2013-03-18
• Study Start: 2013-05-13
• Primary Completion: 2018-02-19
• Study Completion: 2018-02-19
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-23
• Last Update Posted: 2018-03-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Irinotecan and nimotuzumab	Irinotecan	Adminitration of irinotecan 150 mg/m2 IV once every 2 weeks and nimotuzumab 400 mg IV once weekly
Irinotecan and nimotuzumab	Nimotuzumab	Adminitration of irinotecan 150 mg/m2 IV once every 2 weeks and nimotuzumab 400 mg IV once weekly
Irinotecan	Irinotecan	Administration of irinotecan 150 mg/m2 IV once every 2 weeks

Primary Outcome Measures

Name	Time	Method
Overall Survival	Around 4.5 years after first subject randomization	Overall survival is defined as the time from the date of randomization to the date of the death from any cause.

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events	Around 4.5 years after first subject randomization	Incidence of adverse events using latest CTCAE version 4 including minor version
Overall Response Rate	Around 4.5 years after first subject randomization	Overall Response Rate is defined as the proportion of subjects with CR or PR in the best overall response.
Progression Free Survival	Around 4.5 years after first subject randomization	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.
Disease Control Rate	Around 4.5 years after first subject randomization	Disease Control Rate is defined as the proportion of subjects with CR, PR or SD in the best overall response.

Trial Locations

Locations (2)

National Cancer Center Hospital East; 🇯🇵 Kashiwa, Chiba, Japan

Hwansun Junnam hospital; 🇰🇷 Gwangju, Korea, Republic of