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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 ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01813253
First Posted: March 18, 2013
Last Update Posted: November 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Daiichi Sankyo Co., Ltd.
Information provided by (Responsible Party):
Kuhnil Pharmaceutical Co., Ltd.
  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: None (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
Actual 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01813253


Locations
Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-0882
Aichi, Japan
Akita, Japan
Aomori, Japan
Chiba, Japan, 206-8717
Ehime, Japan
Fukuoka, Japan
Hiroshima, Japan
Hokkaido, Japan
Hyogo, Japan
Ishikawa-ken, Japan, 920-8530
Kanagawa, Japan
Kumamoto, Japan
Kyoto, Japan
Nagano, Japan
Nigata, Japan
Osaka, Japan
Saitama, Japan
Shizuoka, Japan, 420-8527
Shizuoka, Japan
Tochigi, Japan
Tokyo, Japan
Toyama, Japan
Korea, Republic of
Busan, Korea, Republic of
Daegu, Korea, Republic of
Gyeonggi-do, Korea, Republic of
Hwansun, 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
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
First Submitted: March 11, 2013
First Posted: March 18, 2013
Last Update Posted: November 28, 2017
Last Verified: November 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