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

A Randomized, Open-label, Japan-Korea-Taiwan 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 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.

Study Overview

• Status: Terminated
• Conditions: Gastric Cancer; Gastroesophageal Junction Cancer
• Intervention / Treatment: Drug: Irinotecan; Drug: Nimotuzumab

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 Type: Interventional
• Enrollment (Actual): 400
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Aichi, Japan
  • Akita, Japan
  • Aomori, Japan
  • Chiba, Japan, 206-8717
  • Ehime, Japan
  • Fukuoka, Japan
  • Hiroshima, Japan
  • Hokkaido, Japan
  • Hyogo, Japan
  • Ishikawa, Japan, 920-8530
  • Kanagawa, Japan
  • Kumamoto, Japan
  • Kyoto, Japan
  • Nagano, Japan
  • Niigata, Japan
  • Osaka, Japan
  • Saitama, Japan
  • Shizuoka, Japan
  • Shizuoka, Japan, 420-8527
  • Tochigi, Japan
  • Tokyo, Japan
  • Toyama, Japan
  • Chiba
    • Kashiwa, Chiba, Japan, 277-0882
      • National Cancer Center Hospital East
• Korea, Republic of
  • Busan, Korea, Republic of
  • Daegu, Korea, Republic of
  • Gwangju, Korea, Republic of
    • Hwansun Junnam hospital
  • Gyeonggi-do, Korea, Republic of
  • Incheon, Korea, Republic of
  • Jeonju, Korea, Republic of
  • Seongnam, Korea, Republic of
  • Seoul, Korea, Republic of
  • Yangsan, Korea, Republic of
• Taiwan
  • Changhua, Taiwan
  • Tainan, Taiwan
  • Taipei, Taiwan
  • Taoyuan, Taiwan
  • Thaichung, Taiwan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Irinotecan and nimotuzumab; Adminitration of irinotecan 150 mg/m2 IV once every 2 weeks and nimotuzumab 400 mg IV once weekly	Drug: Irinotecan; 150 mg/m2 IV once every 2 weeks until progression or unacceptable toxicity develops; Other Names: Boryung irinotecan; Drug: Nimotuzumab; 400mg IV once weekly until progression or unacceptable toxicity develops; Other Names: DE-766
ACTIVE_COMPARATOR: Irinotecan; Administration of irinotecan 150 mg/m2 IV once every 2 weeks	Drug: Irinotecan; 150 mg/m2 IV once every 2 weeks until progression or unacceptable toxicity develops; Other Names: Boryung irinotecan

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kuhnil Pharmaceutical Co., Ltd.
• Collaborators: Daiichi Sankyo Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 13, 2013
• Primary Completion (ACTUAL): February 19, 2018
• Study Completion (ACTUAL): February 19, 2018

Study Registration Dates

• First Submitted: March 11, 2013
• First Submitted That Met QC Criteria: March 13, 2013
• First Posted (ESTIMATE): March 18, 2013

Study Record Updates

• Last Update Posted (ACTUAL): March 26, 2018
• Last Update Submitted That Met QC Criteria: March 23, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: second line; epidermal growth factor receptor
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase Inhibitors; Antineoplastic Agents, Immunological; Topoisomerase I Inhibitors; Irinotecan; Nimotuzumab
• Other Study ID Numbers: DE766-A-J302