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IPO-NEC Trial
NCT01480986Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2011
- Primary completion
- Sep 2012
- Countries
- 1
- Sponsor
- Peking University
- Modality
- Peptides, Small Molecules
- Conditions
- neuroendocrine carcinoma (NEC)
01
Overview
Phase 2, open-label, single-arm trial of irinotecan, cisplatin and octreotide in neuroendocrine carcinoma (NEC), sponsored by Peking University. Primary endpoint: Progression-Free Survival at 2 years. Started Sep 2011; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Treatment arm
Sequential therapy of Irinotecan + Cisplatin followed by Octreotide LAR
03
Who it enrols
Adults with histologically confirmed poorly differentiated GI neuroendocrine carcinoma (grade 2 or 3), no prior systemic therapy for advanced disease, measurable disease, adequate organ function, and KPS >= 70.
04
Endpoints
Primary
Progression-Free Survival
Secondary
Disease Control Rate
Overall Survival
Safety
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