Hepatocellular Carcinoma
Conditions
Keywords
Hepatocellular carcinoma, dose-finding study, randomized trial, medical treatment, RAD001, sorafenib, Advanced hepatocellular cancer (HCC)
Brief summary
Phase 1 Evaluate the safety and tolerability of RAD001 in combination with sorafenib in patients with advance hepatocellular cancer (HCC) and to determine the maximum tolerated dose (MTD) Phase 2 To estimate the treatment effect as a measure of anti-tumor activity in terms of Time to Progression (TTP) of the combination of RAD001 plus sorafenib, at the MTD, as compared to sorafenib alone
Interventions
DRUGRAD001
DRUGRAD001, sorafenib
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Advanced liver cancer * No previous systemic therapy for liver cancer * Measurable disease on CT or MRI * ECOG 1 or less * Child-Pugh A
Exclusion criteria
* Active bleeding during the last 30 days * Known history of HIV seropositivity * Any severe and/or uncontrolled medical conditions including Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose of combination RAD001+sorafenib | Until maximum tolerated dose is determined |
| Time to disease progression assessed when 60 events have been observed | Until number of events are reached |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability of the combination of RAD001 plus sorafenib as measured by the rate and severity of adverse events | Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity |
| Tumor response | Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity |
| Biomarkers- effect of treatment on soluble markers of angiogenesis and apoptosis | Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity |
| Overall tumor response (phase 2) | Estimate of 1 year for each patient - Until number of events reached and final analysis |
| Progression Free Survivor, Overall Survivor (phase 2) | Estimate of 1 year for each patient - Until number of events reached and final analysis |
| Safety and tolerability - of the combination of RAD001 plus sorafenib as measured by the rate and severity of adverse events (phase 2) | Estimate of 1 year for each patient - Until number of events reached and final analysis |
| Pharmokinetics of RAD001 at pre-dose and 1 hour and 2 hours post-dose (phase 2) | Estimate of 1 year for each patient - Until number of events reached and final analysis |
| Biomarkers effect of treatment on soluble markers of angiogenesis and apoptosis (phase 2) | Estimate of 1 year for each patient - Until number of events reached and final analysis |
| Pharmokinetics of RAD001 at pre-dose and 1 hour and 2 hours post-dose | Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity |
Countries
Netherlands, South Korea, Spain, Taiwan, United States
Outcome results
None listed