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

NCT ID: NCT01813253

Last Updated: 2018-03-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-13
• Study Completion Date: 2018-02-19

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.

Conditions

Gastric Cancer; Gastroesophageal Junction Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Irinotecan and nimotuzumab

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

Group Type: EXPERIMENTAL

Irinotecan

Intervention Type: DRUG

150 mg/m2 IV once every 2 weeks until progression or unacceptable toxicity develops

Nimotuzumab

Intervention Type: DRUG

400mg IV once weekly until progression or unacceptable toxicity develops

Irinotecan

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

Group Type: ACTIVE_COMPARATOR

Irinotecan

Intervention Type: DRUG

150 mg/m2 IV once every 2 weeks until progression or unacceptable toxicity develops

Interventions

Irinotecan

150 mg/m2 IV once every 2 weeks until progression or unacceptable toxicity develops

Intervention Type: DRUG

Nimotuzumab

400mg IV once weekly until progression or unacceptable toxicity develops

Intervention Type: DRUG

Other Intervention Names

Boryung irinotecan; DE-766

Eligibility 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daiichi Sankyo Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Kuhnil Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Aichi, , Japan

Akita, , Japan

Aomori, , Japan

Chiba, , Japan

Ehime, , Japan

Fukuoka, , Japan

Hiroshima, , Japan

Hokkaido, , Japan

Hyōgo, , Japan

Ishikawa, , Japan

Kanagawa, , Japan

Kumamoto, , Japan

Kyoto, , Japan

Nagano, , Japan

Niigata, , Japan

Osaka, , Japan

Saitama, , Japan

Shizuoka, , Japan

Shizuoka, , Japan

Tochigi, , Japan

Tokyo, , Japan

Toyama, , Japan

Busan, , South Korea

Daegu, , South Korea

Hwansun Junnam hospital

Gwangju, , South Korea

Gyeonggi-do, , South Korea

Incheon, , South Korea

Jeonju, , South Korea

Seongnam, , South Korea

Seoul, , South Korea

Yangsan, , South Korea

Changhua, , Taiwan

Tainan City, , Taiwan

Taipei, , Taiwan

Taoyuan District, , Taiwan

Thaichung, , Taiwan

Countries

Japan; South Korea; Taiwan

Other Identifiers

DE766-A-J302

Identifier Type: -

Identifier Source: org_study_id