Phase 3
N=546
Global Study Looking at the Combination of RAD001 Plus Best Supportive Care (BSC) and Placebo Plus BSC to Treat Patients With Advanced Hepatocellular Carcinoma.
Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT01035229 ↗Enrolled (actual)
546
Serious AEs
43.3%
Results posted
Oct 2014
Primary outcome: Primary: Overall Survival (OS) — 7.56; 7.33 Months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Everolimus (Drug); Everolimus Placebo (Drug); Best Supportive Care (BSC) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
7.56; 7.33 | — |
| SECONDARY Time to Tumor Progression (TTP) |
2.96; 2.60 | — |
| SECONDARY Percentage of Participants With Disease Control Rate (DCR) |
56.1; 45.1 | — |
| SECONDARY Time to Definitive Deterioration of ECOG Performance Score (PS) Score |
4.27; 4.47 | — |
| SECONDARY Time to Definitive Deterioration of EORTC QLQ-C30 Scores |
2.86; 3.45 | — |
| SECONDARY Pharmacokinetics Assessments - Cmin |
16.141; 9.318 | — |
| SECONDARY Pharmacokinetics Assessments - Cmax |
47.881; 31.592 | — |
Summary
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.
Eligibility Criteria
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:
- 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.
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
- ECOG performance status of ≤ 2
- Child-Pugh A
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01035229). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.