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

Primary Purpose

Gastric Cancer, Gastroesophageal Junction Cancer

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Irinotecan
Nimotuzumab
Sponsored by
Kuhnil Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring epidermal growth factor receptor, second line

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Cancer Center Hospital East
  • Hwansun Junnam hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Irinotecan and nimotuzumab

Irinotecan

Arm Description

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

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

Outcomes

Primary Outcome Measures

Overall Survival
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
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
Overall Response Rate is defined as the proportion of subjects with CR or PR in the best overall response.
Disease Control Rate
Disease Control Rate is defined as the proportion of subjects with CR, PR or SD in the best overall response.
Incidence of adverse events
Incidence of adverse events using latest CTCAE version 4 including minor version

Full Information

First Posted
March 11, 2013
Last Updated
March 23, 2018
Sponsor
Kuhnil Pharmaceutical Co., Ltd.
Collaborators
Daiichi Sankyo Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01813253
Brief Title
Phase 3 Study of Nimotuzumab and Irinotecan as Second Line With Advanced or Recurrect Gastric and Gastroesophageal Junction Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Study Start Date
May 13, 2013 (Actual)
Primary Completion Date
February 19, 2018 (Actual)
Study Completion Date
February 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kuhnil Pharmaceutical Co., Ltd.
Collaborators
Daiichi Sankyo Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Gastroesophageal Junction Cancer
Keywords
epidermal growth factor receptor, second line

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Irinotecan and nimotuzumab
Arm Type
Experimental
Arm Description
Adminitration of irinotecan 150 mg/m2 IV once every 2 weeks and nimotuzumab 400 mg IV once weekly
Arm Title
Irinotecan
Arm Type
Active Comparator
Arm Description
Administration of irinotecan 150 mg/m2 IV once every 2 weeks
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Other Intervention Name(s)
Boryung irinotecan
Intervention Description
150 mg/m2 IV once every 2 weeks until progression or unacceptable toxicity develops
Intervention Type
Drug
Intervention Name(s)
Nimotuzumab
Other Intervention Name(s)
DE-766
Intervention Description
400mg IV once weekly until progression or unacceptable toxicity develops
Primary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival is defined as the time from the date of randomization to the date of the death from any cause.
Time Frame
Around 4.5 years after first subject randomization
Secondary Outcome Measure Information:
Title
Progression Free Survival
Description
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.
Time Frame
Around 4.5 years after first subject randomization
Title
Overall Response Rate
Description
Overall Response Rate is defined as the proportion of subjects with CR or PR in the best overall response.
Time Frame
Around 4.5 years after first subject randomization
Title
Disease Control Rate
Description
Disease Control Rate is defined as the proportion of subjects with CR, PR or SD in the best overall response.
Time Frame
Around 4.5 years after first subject randomization
Title
Incidence of adverse events
Description
Incidence of adverse events using latest CTCAE version 4 including minor version
Time Frame
Around 4.5 years after first subject randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Advanced or recurrent subjects with gastric or gastroesophageal junction adenocarcinoma. 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. Subjects with EGFR overexpression (2+ or 3+ in IHC) Exclusion Criteria: Subjects who have received irinotecan Subjects who have received EGFR-directed therapy Other active malignancy within the last 5 years
Facility Information:
Facility Name
National Cancer Center Hospital East
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-0882
Country
Japan
City
Aichi
Country
Japan
City
Akita
Country
Japan
City
Aomori
Country
Japan
City
Chiba
ZIP/Postal Code
206-8717
Country
Japan
City
Ehime
Country
Japan
City
Fukuoka
Country
Japan
City
Hiroshima
Country
Japan
City
Hokkaido
Country
Japan
City
Hyogo
Country
Japan
City
Ishikawa
ZIP/Postal Code
920-8530
Country
Japan
City
Kanagawa
Country
Japan
City
Kumamoto
Country
Japan
City
Kyoto
Country
Japan
City
Nagano
Country
Japan
City
Niigata
Country
Japan
City
Osaka
Country
Japan
City
Saitama
Country
Japan
City
Shizuoka
ZIP/Postal Code
420-8527
Country
Japan
City
Shizuoka
Country
Japan
City
Tochigi
Country
Japan
City
Tokyo
Country
Japan
City
Toyama
Country
Japan
City
Busan
Country
Korea, Republic of
City
Daegu
Country
Korea, Republic of
Facility Name
Hwansun Junnam hospital
City
Gwangju
Country
Korea, Republic of
City
Gyeonggi-do
Country
Korea, Republic of
City
Incheon
Country
Korea, Republic of
City
Jeonju
Country
Korea, Republic of
City
Seongnam
Country
Korea, Republic of
City
Seoul
Country
Korea, Republic of
City
Yangsan
Country
Korea, Republic of
City
Changhua
Country
Taiwan
City
Tainan
Country
Taiwan
City
Taipei
Country
Taiwan
City
Taoyuan
Country
Taiwan
City
Thaichung
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

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