Japan/Korea Joint Phase II Study of Nimotuzumab plus Irinotecan in Patients with Advanced or Recurrent Gastric Cancer

Phase 2

• Conditions: Advanced or Recurrent Gastric Cancer Refractory to 5-fluorouracil-containing Regimens

• Registration Number: JPRN-jRCT2080220818
• Lead Sponsor: DAIICHISANKYO Co.,Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-08-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Histologically or cytologically confirmed gastric adenocarcinoma.
Unresectable or recurrent gastric cancer patients, refractory to 5-fluorouracil-based agents or 5-fluorouracil-containing therapy. Only one prior regimen is eligible.
ECOG Performance Status is 0-1

Exclusion Criteria

Patients who previously received irinotecan
Patients who previously received EGFR-directed therapy (e.g. cetuximab, erlotinib).
Patients with any of the following severe or uncontrolled intercurrent diseases

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression Free Survival<br>RECIST (ver. 1.0)

Secondary Outcome Measures

Name	Time	Method
Response rate, disease control rate, duration of response, time to progression, time to treatment failure, overall survival, safety, pharmacokinetics<br>RECIST (ver. 1.0), NCI-CTC (ver. 3.0)