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

Sponsor
Kuhnil Pharmaceutical Co., Ltd.
Study ID
NCT01813253
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan — DRUG
    150 mg/m2 IV once every 2 weeks until progression or unacceptable toxicity develops
  • Nimotuzumab — DRUG
    400mg IV once weekly until progression or unacceptable toxicity develops

Study Details

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.

Key Dates

Start date
May 13, 2013
Status verified
Mar 2018
Primary completion
Feb 19, 2018
Completion
Feb 19, 2018

Study Design

Enrollment
400 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Irinotecan and nimotuzumab
    Adminitration of irinotecan 150 mg/m2 IV once every 2 weeks and nimotuzumab 400 mg IV once weekly
  • Active Comparator: Irinotecan
    Administration of irinotecan 150 mg/m2 IV once every 2 weeks

Primary Outcome Measure

Overall Survival [ Time Frame: Around 4.5 years after first subject randomization ]

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