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

NCT01813253 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2018-03-26

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Irinotecan

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

DRUG

Nimotuzumab

400mg IV once weekly until progression or unacceptable toxicity develops

Sponsors & Collaborators

  • Daiichi Sankyo Co., Ltd.

    collaborator INDUSTRY

  • Kuhnil Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-13
Primary Completion
2018-02-19
Completion
2018-02-19

Countries

  • Japan
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01813253 on ClinicalTrials.gov