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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 July 2016 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: July 6, 2016
Last verified: July 2016
  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: Open Label
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: Mee young Hwang 82-2-2175-9763 myhwang@kuhnil.com
Contact: Kyeong sun Shin 82-2-2175-9750 ksshin@kuhnil.com

Locations
Japan
National Cancer Center Hospital East Recruiting
Kashiwa, Chiba, Japan, 277-0882
Contact: Kohei Shitara         
Recruiting
Aichi, Japan
Recruiting
Akita, Japan
Recruiting
Aomori, Japan
Recruiting
Chiba, Japan, 206-8717
Recruiting
Ehime, Japan
Recruiting
Fukuoka, Japan
Recruiting
Hiroshima, Japan
Recruiting
Hokkaido, Japan
Recruiting
Hyogo, Japan
Recruiting
Ishikawa-ken, Japan, 920-8530
Recruiting
Ishikawa, Japan
Recruiting
Kanagawa, Japan
Recruiting
Kumamoto, Japan
Recruiting
Kyoto, Japan
Recruiting
Nagano, Japan
Recruiting
Nigata, Japan
Recruiting
Osaka, Japan
Recruiting
Saitama, Japan
Recruiting
Shizuoka, Japan, 420-8527
Recruiting
Shizuoka, Japan
Recruiting
Tochigi, Japan
Recruiting
Tokyo, Japan
Recruiting
Toyama, Japan
Korea, Republic of
Recruiting
Busan, Korea, Republic of
Recruiting
Daegu, Korea, Republic of
Recruiting
Gyeonggi-do, Korea, Republic of
Recruiting
Hwansun, Korea, Republic of
Recruiting
Incheon, Korea, Republic of
Recruiting
Jeonju, Korea, Republic of
Recruiting
Seongnam, Korea, Republic of
Recruiting
Seoul, Korea, Republic of
Recruiting
Yangsan, Korea, Republic of
Taiwan
Not yet recruiting
Changhua, Taiwan
Not yet recruiting
Tainan, Taiwan
National Taiwan Unversity Hospital Not yet recruiting
Taipei, Taiwan
Not yet recruiting
Taipei, Taiwan
Not yet recruiting
Taoyuan, Taiwan
Not yet 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: July 6, 2016

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 March 23, 2017