Suspended

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Irinotecan

+ Nimotuzumab

+ Irinotecan

Drug
Who is being recruted

Digestive System Diseases+5

+ Digestive System Neoplasms

+ Gastrointestinal Diseases

Over 20 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: May 2013
See protocol details

Summary

Principal SponsorKuhnil Pharmaceutical Co., Ltd.
Last updated: March 26, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: May 13, 2013

Actual date on which the first participant was enrolled.

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.

NCT01813253
Principal SponsorKuhnil Pharmaceutical Co., Ltd.
Last updated: March 26, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

400 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 20 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsNeoplasmsNeoplasms by SiteStomach DiseasesStomach Neoplasms

Criteria

3 inclusion criteria required to participate
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)
3 exclusion criteria prevent from participating
Other active malignancy within the last 5 years
Subjects who have received EGFR-directed therapy
Subjects who have received irinotecan

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 37 locations

National Cancer Center Hospital East

Kashiwa, JapanOpen National Cancer Center Hospital East in Google Maps

Aichi, Japan

Akita, Japan

Aomori, Japan
Suspended37 Study Centers