Hepatocellular CarcinomaPhase 1NCT00828594
Global Study Looking at the Combination of RAD001 and Sorafenib to Treat Patients With Advanced Hepatocellular Carcinoma
A Phase 1 study testing RAD001 and RAD001, sorafenib in people with Hepatocellular Carcinoma, run by Novartis Pharmaceuticals at 8 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- RAD001 and RAD001, sorafenib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 8 sitesin 5 countries
- Study dates
- Dec 2008to Jun 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced liver cancer
- No previous systemic therapy for liver cancer
- Measurable disease on CT or MRI
- ECOG 1 or less
- Child-Pugh A
Who cannot join
- 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
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
United States3 sites
City of Hope Medical Center
Duarte, California, 91010
Duke University
Durham, North Carolina, 27710
UCLA Department of Medicine
Los Angeles, California, 90005
Spain2 sites
Novartis Investigative Site
Barcelona
Novartis Invstigative Site
Madrid
About this study
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
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
- Conditions
- Hepatocellular Carcinoma
- Being tested
- RAD001, RAD001, sorafenib
- Keywords
- Hepatocellular carcinoma, dose-finding study, randomized trial, medical treatment, RAD001, sorafenib, Advanced hepatocellular cancer (HCC)
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAD001Drug
RAD001, sorafenibDrug
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: RAD001 plus sorafenib | Experimental | Not described Receives: Drug: RAD001; Drug: RAD001, sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose of combination RAD001+sorafenib
Measured: Until maximum tolerated dose is determined
Time to disease progression assessed when 60 events have been observed
Measured: Until number of events are reached
Secondary outcomes (9)
Safety and tolerability of the combination of RAD001 plus sorafenib as measured by the rate and severity of adverse events
Measured: Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity
Tumor response
Measured: 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
Measured: 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)
Measured: Estimate of 1 year for each patient - Until number of events reached and final analysis
Progression Free Survivor, Overall Survivor (phase 2)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00828594
- Sponsor's protocol ID
- CRAD001O2101
- Status last verified
- Apr 2013
- First submitted
- 9 Jan 2009
- Last updated
- 11 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00828594
- Acronym / sponsor ID
- CRAD001O2101
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular carcinoma, dose-finding study, randomized trial, medical treatment, RAD001, sorafenib, Advanced hepatocellular cancer (HCC)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 26 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase 1: RAD001 plus sorafenib | Experimental | Drug: RAD001, Drug: RAD001, sorafenib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Advanced liver cancer
- No previous systemic therapy for liver cancer
- Measurable disease on CT or MRI
- ECOG 1 or less
- Child-Pugh A
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RAD001 | Drug | Phase 1: RAD001 plus sorafenib |
| RAD001, sorafenib | Drug | Phase 1: RAD001 plus sorafenib |
Primary outcome
Maximum tolerated dose of combination RAD001+sorafenib
Time frame: Until maximum tolerated dose is determined
Time to disease progression assessed when 60 events have been observed
Time frame: Until number of events are reached
9 secondary outcomes
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
Tumor response
Time frame: 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
Time frame: 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)
Time frame: Estimate of 1 year for each patient - Until number of events reached and final analysis
Progression Free Survivor, Overall Survivor (phase 2)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2013.
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RAD001 and RAD001, sorafenib in people with Hepatocellular Carcinoma, run by Novartis Pharmaceuticals at 8 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Spain, Netherlands, South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose of combination RAD001+sorafenib (time frame: Until maximum tolerated dose is determined). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2013.