Featured Clinical Trial:
Hepatocellular Carcinoma (product/compound: Everolimus)
ClinicAid Locations: Southern California – Fountain Valley
Status:
Open for enrollment (accepting patients).
Please contact us and mention Trial ID NCT01035229.
Condition: Hepatocellular Carcinoma
Product Name/Compound: Everolimus
Full Study Title: A randomized phase III, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of everolimus (RAD001) in adult patients with advanced Hepatocellular Carcinoma after failure of sorafenib treatment – The EVOLVE-1 Study
Study Summary: Compare treatment with RAD001 plus best supportive care (BSC) to placebo plus BSC in patients with advanced HCC whose disease progressed while on or after sorafenib treatment or who are intolerant to sorafenib.
Eligible Participants:
Inclusion (Eligible):
- Advanced liver cancer
- Prior systemic treatment with sorafenib for advanced HCC and for whom their disease progressed during or after sorafenib treatment, or were intolerant to sorafenib treatment. Specifically, this can be defined as:
- Documented radiological confirmation (radiology scans or report) of disease progression during or after sorafenib treatment
- Intolerance to sorafenib (at any dose and/or duration) is defined as documented sorafenib-related grade 3 or 4 adverse events that led to sorafenib discontinuation.
- ECOG performance status of ≤2
- Child-Pugh A
Exclusion (Not Eligible):
- Active bleeding during the last 28 days
- Prior therapy with mTOR inhibitors
- Prior liver or other organ transplantation which mandates systemic immunosuppression
- Other protocol-defined inclusion/exclusion criteria may apply
Study Phase: Phase III (What are Phases?)
To receive information and updates for this trial:
Please contact us and mention the Trial ID below.
Trial ID (ClinicalTrials.gov): NCT01035229
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