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High-dose Octreotide LAR in Progressive Neuroendocrine Tumors (HIDONET)
NCT00990535Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2006
- Primary completion
- Dec 2007
- Countries
- 1
- Sponsor
- University of Naples Federico II
- Drugs
- octreotide LAR
- Conditions
- Neuroendocrine Neoplasm (NEN)
01
Overview
Phase 2, open-label, single-arm trial of octreotide LAR in Neuroendocrine Neoplasm (NEN), sponsored by University of Naples Federico II. Primary endpoint: Tumor stabilization at 6 months. Started Jan 2006; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Octreotide-LAR
Single experimental arm receiving high-dose density Octreotide LAR.
03
Who it enrols
Patients with histologically documented well-differentiated neuroendocrine tumors (WDNET) showing tumor progression under standard dose treatment with Octreotide LAR (30 mg every 28 days) for at least 6 months.
04
Endpoints
Primary
Tumor stabilization
Secondary
Symptoms improvement
Decrease of chromogranin-A
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