NCT01813253

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P25-P50 for phase_3 gastric-cancer

Timeline
Completed

Started May 2013

Geographic Reach
3 countries

37 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 18, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

May 13, 2013

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2018

Completed
Last Updated

March 26, 2018

Status Verified

March 1, 2018

Enrollment Period

4.8 years

First QC Date

March 11, 2013

Last Update Submit

March 23, 2018

Conditions

Gastric CancerGastroesophageal Junction Cancer

Keywords

epidermal growth factor receptorsecond line

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Progression Free Survival

    Around 4.5 years after first subject randomization

  • Overall Response Rate

    Around 4.5 years after first subject randomization

  • Disease Control Rate

    Around 4.5 years after first subject randomization

  • Incidence of adverse events

    Around 4.5 years after first subject randomization

Study Arms (2)

Irinotecan and nimotuzumab

EXPERIMENTAL

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

Drug: IrinotecanDrug: Nimotuzumab

Irinotecan

ACTIVE COMPARATOR

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

Drug: Irinotecan

Interventions

IrinotecanDRUG

150 mg/m2 IV once every 2 weeks until progression or unacceptable toxicity develops

Also known as: Boryung irinotecan
IrinotecanIrinotecan and nimotuzumab
NimotuzumabDRUG

400mg IV once weekly until progression or unacceptable toxicity develops

Also known as: DE-766
Irinotecan and nimotuzumab

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Subjects who have received irinotecan
  • Subjects who have received EGFR-directed therapy
  • Other active malignancy within the last 5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (37)

National Cancer Center Hospital East

Kashiwa, Chiba, 277-0882, Japan

Location

Unknown Facility

Aichi, Japan

Location

Unknown Facility

Akita, Japan

Location

Unknown Facility

Aomori, Japan

Location

Unknown Facility

Chiba, 206-8717, Japan

Location

Unknown Facility

Ehime, Japan

Location

Unknown Facility

Fukuoka, Japan

Location

Unknown Facility

Hiroshima, Japan

Location

Unknown Facility

Hokkaido, Japan

Location

Unknown Facility

Hyōgo, Japan

Location

Unknown Facility

Ishikawa, 920-8530, Japan

Location

Unknown Facility

Kanagawa, Japan

Location

Unknown Facility

Kumamoto, Japan

Location

Unknown Facility

Kyoto, Japan

Location

Unknown Facility

Nagano, Japan

Location

Unknown Facility

Niigata, Japan

Location

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Saitama, Japan

Location

Unknown Facility

Shizuoka, 420-8527, Japan

Location

Unknown Facility

Shizuoka, Japan

Location

Unknown Facility

Tochigi, Japan

Location

Unknown Facility

Tokyo, Japan

Location

Unknown Facility

Toyama, Japan

Location

Unknown Facility

Busan, South Korea

Location

Unknown Facility

Daegu, South Korea

Location

Hwansun Junnam hospital

Gwangju, South Korea

Location

Unknown Facility

Gyeonggi-do, South Korea

Location

Unknown Facility

Incheon, South Korea

Location

Unknown Facility

Jeonju, South Korea

Location

Unknown Facility

Seongnam, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Yangsan, South Korea

Location

Unknown Facility

Changhua, Taiwan

Location

Unknown Facility

Tainan, Taiwan

Location

Unknown Facility

Taipei, Taiwan

Location

Unknown Facility

Taoyuan District, Taiwan

Location

Unknown Facility

Thaichung, Taiwan

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Irinotecannimotuzumab

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2013

First Posted

March 18, 2013

Study Start

May 13, 2013

Primary Completion

February 19, 2018

Study Completion

February 19, 2018

Last Updated

March 26, 2018

Record last verified: 2018-03

Locations

TW(5)KR(9)JP(23)