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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01813253
• Other study ID #: DE766-A-J302
• Status: Terminated
• Phase: Phase 3
• First received: March 11, 2013
• Last updated: March 23, 2018
• Start date: May 13, 2013
• Est. completion date: February 19, 2018

Study information

• Verified date: March 2018
• Source: Kuhnil Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 400
• Est. completion date: February 19, 2018
• Est. primary completion date: February 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Gastroesophageal Junction Cancer
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
Japan	National Cancer Center Hospital East	Kashiwa	Chiba
Korea, Republic of	Hwansun Junnam hospital	Gwangju

Sponsors (2)

Lead Sponsor	Collaborator
Kuhnil Pharmaceutical Co., Ltd.	Daiichi Sankyo Co., Ltd.

Countries where clinical trial is conducted

Japan,  Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	Overall survival is defined as the time from the date of randomization to the date of the death from any cause.	Around 4.5 years after first subject randomization
Secondary	Progression Free Survival	Progression Free Survival is defined as the time from the date of randomization to the date of progression or death from any cause, whichever comes first.	Around 4.5 years after first subject randomization
Secondary	Overall Response Rate	Overall Response Rate is defined as the proportion of subjects with CR or PR in the best overall response.	Around 4.5 years after first subject randomization
Secondary	Disease Control Rate	Disease Control Rate is defined as the proportion of subjects with CR, PR or SD in the best overall response.	Around 4.5 years after first subject randomization
Secondary	Incidence of adverse events	Incidence of adverse events using latest CTCAE version 4 including minor version	Around 4.5 years after first subject randomization