Phase 3 Study of Nimotuzumab and Irinotecan as Second Line With Advanced or Recurrect Gastric and Gastroesophageal Junction Cancer
Conditions
Gastric Cancer - Gastroesophageal Junction Cancer
Conditions: Keywords
epidermal growth factor receptor, second line
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Irinotecan Type: Drug
Name: Nimotuzumab Type: Drug
Overall Status
Recruiting
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 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 20 Years
Gender: Both
Criteria: 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
Locations
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Status: Recruiting
Contact: Kohei Shitara
Aichi, Japan
Status: Recruiting
Akita, Japan
Status: Recruiting
Aomori, Japan
Status: Recruiting
Ehime, Japan
Status: Recruiting
Fukuoka, Japan
Status: Recruiting
Hiroshima, Japan
Status: Recruiting
Hokkaido, Japan
Status: Recruiting
Hyogo, Japan
Status: Recruiting
Ishikawa, Japan
Status: Recruiting
Kanagawa, Japan
Status: Recruiting
Kumamoto, Japan
Status: Recruiting
Kyoto, Japan
Status: Recruiting
Nagano, Japan
Status: Recruiting
Nigata, Japan
Status: Recruiting
Osaka, Japan
Status: Recruiting
Saitama, Japan
Status: Recruiting
Shizuoka, Japan
Status: Recruiting
Tochigi, Japan
Status: Recruiting
Tokyo, Japan
Status: Recruiting
Toyama, Japan
Status: Recruiting
Busan, Korea, Republic of
Status: Recruiting
Daegu, Korea, Republic of
Status: Recruiting
Gyeonggi-do, Korea, Republic of
Status: Recruiting
Hwansun, Korea, Republic of
Status: Recruiting
Incheon, Korea, Republic of
Status: Recruiting
Jeonju, Korea, Republic of
Status: Recruiting
Seongnam, Korea, Republic of
Status: Recruiting
Seoul, Korea, Republic of
Status: Recruiting
Yangsan, Korea, Republic of
Status: Recruiting
Start Date
March 2013
Completion Date
January 2018
Sponsors
Kuhnil Pharmaceutical Co., Ltd.
Source
Kuhnil Pharmaceutical Co., Ltd.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page