Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
The purpose of this study is to 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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:
NOTE:
Sorafenib must be the last antineoplastic treatment before randomization
Prior local and/or hormonal therapy (e.g., tamoxifen) before sorafenib is allowed
One systemic chemotherapy regimen for advanced HCC is allowed before sorafenib treatment
Exclusion criteria
Other protocol-defined inclusion/exclusion criteria may apply
Primary purpose
Allocation
Interventional model
Masking
546 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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