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NCT01035229 · ClinicalTrials.gov registry record · Phase 3
Global Study Looking at the Combination of RAD001 Plus Best Supportive Care (BSC) and Placebo Plus BSC to Treat Patients With Advanced Hepatocellular Carcinoma.
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 546
- Enrollment target
NCT01035229: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT01035229 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 546 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01035229, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 546 participants
- Enrollment target
Study 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.
Primary Outcome
OS was defined as the time from the date of randomization to the date of death from any cause. The comparison of OS between the 2 arms was done using a stratified log-rank test at one-sided 2.5% level of significance.
Interventions
- DRUG Everolimus
- OTHER Best Supportive Care (BSC)
- DRUG Everolimus Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 546 participants |
| Start Date | 2010-04 |
| Est. Completion | 2013-10 |
| Phase | Phase 3 |
What the finished NCT01035229 record still lists
NCT01035229 is an interventional study that assigns participants to a tested intervention. The registered 546 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (29% lower).
The record links to 0 conditions, and to 3 interventions - of which Everolimus is the first listed.
NCT01035229 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01035229 about?
NCT01035229 is a clinical study titled "Global Study Looking at the Combination of RAD001 Plus Best Supportive Care (BSC) and Placebo Plus BSC to Treat Patients With Advanced Hepatocellular Carcinoma.". 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.
What is the current status of trial NCT01035229?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 546 participants. The study started on 2010-04. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01035229?
The interventions under investigation include: Everolimus (DRUG), Best Supportive Care (BSC) (OTHER), Everolimus Placebo (DRUG).
Who is sponsoring clinical trial NCT01035229?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01035229's enrollment target sits among peer trials
546 689th of 2000 higher than 1,312 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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