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NCT00828594 · ClinicalTrials.gov registry record · Phase 1
Global Study Looking at the Combination of RAD001 and Sorafenib to Treat Patients With Advanced Hepatocellular Carcinoma
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 130
- Enrollment target
NCT00828594 is a Phase 1 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 130 participants.
The verdict
NCT00828594, a Phase 1 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 130 participants
- Enrollment target
Study 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
- DRUG RAD001
- DRUG RAD001, sorafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2008-12 |
| Est. Completion | 2011-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00828594
The ClinicalTrials.gov registry entry for NCT00828594 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which RAD001 is the first listed.
NCT00828594 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00828594 about?
NCT00828594 is a clinical study titled "Global Study Looking at the Combination of RAD001 and Sorafenib to Treat 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 (T...
What is the current status of trial NCT00828594?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 130 participants. The study started on 2008-12. Estimated completion is 2011-06.
What interventions are being tested in trial NCT00828594?
The interventions under investigation include: RAD001 (DRUG), RAD001, sorafenib (DRUG).
Who is sponsoring clinical trial NCT00828594?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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