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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by Kuhnil Pharmaceutical Co., Ltd.
Sponsor:
Collaborator:
Daiichi Sankyo Co., Ltd.
Information provided by (Responsible Party):
Kuhnil Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01813253
First received: March 11, 2013
Last updated: April 26, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention Phase
Gastric Cancer
Gastroesophageal Junction Cancer
Drug: Irinotecan
Drug: Nimotuzumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Kuhnil Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 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:
  • Progression Free Survival [ Time Frame: 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.

  • Overall Response Rate [ Time Frame: 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.

  • Disease Control Rate [ Time Frame: 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.

  • Incidence of adverse events [ Time Frame: Around 4.5 years after first subject randomization ]
    Incidence of adverse events using latest CTCAE version 4 including minor version


Estimated Enrollment: 400
Study Start Date: March 2013
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Boryung irinotecan
Drug: Nimotuzumab
400mg IV once weekly until progression or unacceptable toxicity develops
Other Name: 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 Name: Boryung irinotecan

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.
  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01813253

Contacts
Contact: Sun Mi Choi 82-2-2175-9760 smchoi@kuhnil.com
Contact: Kyeong sun Shin 82-2-2175-9750 ksshin@kuhnil.com

Locations
Japan
National Cancer Center Hospital East Active, not recruiting
Kashiwa, Chiba, Japan, 277-0882
Active, not recruiting
Aichi, Japan
Active, not recruiting
Akita, Japan
Active, not recruiting
Aomori, Japan
Active, not recruiting
Chiba, Japan, 206-8717
Active, not recruiting
Ehime, Japan
Active, not recruiting
Fukuoka, Japan
Active, not recruiting
Hiroshima, Japan
Active, not recruiting
Hokkaido, Japan
Active, not recruiting
Hyogo, Japan
Recruiting
Ishikawa-ken, Japan, 920-8530
Active, not recruiting
Kanagawa, Japan
Active, not recruiting
Kumamoto, Japan
Active, not recruiting
Kyoto, Japan
Active, not recruiting
Nagano, Japan
Active, not recruiting
Nigata, Japan
Active, not recruiting
Osaka, Japan
Active, not recruiting
Saitama, Japan
Active, not recruiting
Shizuoka, Japan, 420-8527
Active, not recruiting
Shizuoka, Japan
Active, not recruiting
Tochigi, Japan
Active, not recruiting
Tokyo, Japan
Active, not recruiting
Toyama, Japan
Korea, Republic of
Active, not recruiting
Busan, Korea, Republic of
Active, not recruiting
Daegu, Korea, Republic of
Active, not recruiting
Gyeonggi-do, Korea, Republic of
Active, not recruiting
Hwansun, Korea, Republic of
Active, not recruiting
Incheon, Korea, Republic of
Active, not recruiting
Jeonju, Korea, Republic of
Active, not recruiting
Seongnam, Korea, Republic of
Active, not recruiting
Seoul, Korea, Republic of
Active, not recruiting
Yangsan, Korea, Republic of
Taiwan
Active, not recruiting
Changhua, Taiwan
Active, not recruiting
Tainan, Taiwan
Active, not recruiting
Taipei, Taiwan
Active, not recruiting
Taoyuan, Taiwan
Active, not recruiting
Thaichung, Taiwan
Sponsors and Collaborators
Kuhnil Pharmaceutical Co., Ltd.
Daiichi Sankyo Co., Ltd.
  More Information

Responsible Party: Kuhnil Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01813253     History of Changes
Other Study ID Numbers: DE766-A-J302
Study First Received: March 11, 2013
Last Updated: April 26, 2017

Keywords provided by Kuhnil Pharmaceutical Co., Ltd.:
epidermal growth factor receptor
second line

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Irinotecan
Camptothecin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 28, 2017