WIDE Program: Worldwide Initiative to Develop Everolimus
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Hepatocellular Carcinoma - EVOLVE-1

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EVOLVE-1: Advanced Hepatocellular Carcinoma After Disease Progression or
Intolerance to Sorafenib

EVOLVE-1 (EVerOlimus for LiVer cancer Evaluation-1) is a phase III, randomized, double-blind study of everolimus in advanced hepatocellular carcinoma after failure of sorafenib therapy.

EVOLVE-1: EVerOlimus for LiVer cancer Evaluation

Patients are randomized to receive either everolimus (RAD001) 7.5 mg/day orally or placebo, plus best supportive care. This global clinical trial will enroll 531 patients with HCC in a 2:1 randomization to everolimus or placebo, at more than 100 sites. Patients may have received 1 prior systemic chemotherapy regimen for advanced HCC, providing sorafenib was the last antineoplastic treatment prior to entering the study.

 

EVOLVE-1 Key facts
Primary endpoint: Overall survival
Secondary endpoints:
Time to tumor progression
Disease control rate (complete response + partial response + stable disease)
Quality of life
Everolimus pharmacokinetics
Time to definitive deterioration in Eastern Cooperative Oncology Group performance status
Safety
Target enrollment: 531

 

 
EVOLVE-1 Study Design: EVerOlimus for LiVer cancer Evaluation-1
*Treatment until disease progression, unacceptable toxicity, or discontinuation for any other reason.
 
ClinicalTrials.gov identifier: NCT01035229; Novartis Protocol CRAD001O2301.
 
Click here to learn more about this clinical trial and participating centers from ClinicalTrials.gov.
 
Disclaimer : These are investigational studies; there is no guarantee that everolimus will become commercially available for these indications
 
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