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RAD001 in Advanced Hepatocellular Carcinoma
NCT00390195Phase 2
Key facts
- Status
- Unknown
- Start
- Oct 2006
- Primary completion
- Jun 2010
- Countries
- 1
- Sponsor
- National Health Research Institutes
- Modality
- Small Molecules
- Drugs
- everolimus
- Conditions
- hepatocellular carcinoma (HCC)
01
Overview
Phase 2, randomised, open-label trial of everolimus in hepatocellular carcinoma (HCC) (2 arms), sponsored by National Health Research Institutes. Primary endpoints: Maximum Tolerated Dose and Disease Control Rate. Status: unknown.
02
Design
2 arms- Study design
- RandomizedOpen-label
Daily Schedule
RAD001 administered once daily
Weekly Schedule
RAD001 administered once weekly
03
Who it enrols
Patients with measurable, metastatic or locally advanced HCC who have failed prior local therapy, Child-Pugh score <= 9, and adequate organ function.
04
Endpoints
Primary
Maximum Tolerated Dose
Disease Control Rate
Secondary
Dose-Limiting Toxicity
Pharmacokinetics
Pharmacogenetic Study
Surrogate Marker Study
Overall Survival
Toxicity Profile
Time to Tumor Progression
Serum Alpha-Fetoprotein Change
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