Trials / Terminated
TerminatedNCT01813253
Phase 3 Study of Nimotuzumab and Irinotecan as Second Line With Advanced or Recurrect Gastric and Gastroesophageal Junction Cancer
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
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 400 (actual)
- Sponsor
- Kuhnil Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2013-05-13
- Primary completion
- 2018-02-19
- Completion
- 2018-02-19
- First posted
- 2013-03-18
- Last updated
- 2018-03-26
Locations
37 sites across 3 countries: Japan, South Korea, Taiwan
Source: ClinicalTrials.gov record NCT01813253. Inclusion in this directory is not an endorsement.