Overview

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

Status:
Terminated

Trial end date:
2018-02-19

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Kuhnil Pharmaceutical Co., Ltd.

Collaborator:

Daiichi Sankyo Co., Ltd.

Treatments:

Camptothecin
Irinotecan
Nimotuzumab

Criteria

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