Global Study Looking at the Combination of RAD001 and Sorafenib to Treat Patients With Advanced Hepatocellular Carcinoma
This study has been terminated.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00828594
First received: January 9, 2009
Last updated: April 9, 2013
Last verified: April 2013
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatocellular Carcinoma |
Drug: RAD001 Drug: RAD001, sorafenib |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1 Open Label/ Phase 2 Randomized, Double-blind, Multicenter Study Investigating the Combination of RAD001 and Sorafenib (Nexavar®) in Patients With Advanced Hepatocellular Carcinoma |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Maximum tolerated dose of combination RAD001+sorafenib [ Time Frame: Until maximum tolerated dose is determined ] [ Designated as safety issue: Yes ]
- Time to disease progression assessed when 60 events have been observed [ Time Frame: Until number of events are reached ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Safety and tolerability of the combination of RAD001 plus sorafenib as measured by the rate and severity of adverse events [ Time Frame: Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity ] [ Designated as safety issue: Yes ]
- Tumor response [ Time Frame: Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity ] [ Designated as safety issue: Yes ]
- Biomarkers- effect of treatment on soluble markers of angiogenesis and apoptosis [ Time Frame: Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity ] [ Designated as safety issue: Yes ]
- Overall tumor response (phase 2) [ Time Frame: Estimate of 1 year for each patient - Until number of events reached and final analysis ] [ Designated as safety issue: Yes ]
- Progression Free Survivor, Overall Survivor (phase 2) [ Time Frame: Estimate of 1 year for each patient - Until number of events reached and final analysis ] [ Designated as safety issue: Yes ]
- Safety and tolerability - of the combination of RAD001 plus sorafenib as measured by the rate and severity of adverse events (phase 2) [ Time Frame: Estimate of 1 year for each patient - Until number of events reached and final analysis ] [ Designated as safety issue: Yes ]
- Pharmokinetics of RAD001 at pre-dose and 1 hour and 2 hours post-dose (phase 2) [ Time Frame: Estimate of 1 year for each patient - Until number of events reached and final analysis ] [ Designated as safety issue: Yes ]
- Biomarkers effect of treatment on soluble markers of angiogenesis and apoptosis (phase 2) [ Time Frame: Estimate of 1 year for each patient - Until number of events reached and final analysis ] [ Designated as safety issue: Yes ]
- Pharmokinetics of RAD001 at pre-dose and 1 hour and 2 hours post-dose [ Time Frame: Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity ] [ Designated as safety issue: Yes ]
| Enrollment: | 130 |
| Study Start Date: | December 2008 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Phase 1: RAD001 plus sorafenib | Drug: RAD001 Drug: RAD001, sorafenib |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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/exclusion criteria may apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00828594
Locations
| United States, California | |
| City of Hope Medical Center | |
| Duarte, California, United States, 91010 | |
| UCLA Department of Medicine | |
| Los Angeles, California, United States, 90005 | |
| United States, North Carolina | |
| Duke University | |
| Durham, North Carolina, United States, 27710 | |
| Korea, Republic of | |
| Novartis Investigative Site | |
| Seoul, Korea, Republic of | |
| Netherlands | |
| Novartis Investigative Site | |
| Amsterdam, Netherlands | |
| Spain | |
| Novartis Investigative Site | |
| Barcelona, Spain | |
| Novartis Invstigative Site | |
| Madrid, Spain | |
| Taiwan | |
| Novartis Investigative Site | |
| Tainan, Taiwan | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00828594 History of Changes |
| Other Study ID Numbers: | CRAD001O2101 |
| Study First Received: | January 9, 2009 |
| Last Updated: | April 9, 2013 |
| Health Authority: | United States: Food and Drug Administration Korea: Food and Drug Administration Spain: Ethics Committee Taiwan: Department of Health Hong Kong: Department of Health Netherlands: Medicines Evaluation Board (MEB) |
Keywords provided by Novartis:
|
Hepatocellular carcinoma dose-finding study randomized trial medical treatment |
RAD001 sorafenib Advanced hepatocellular cancer (HCC) |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases Sirolimus Everolimus Sorafenib |
Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013