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NCT00410124 · ClinicalTrials.gov registry record · Phase 3
RAD001 Plus Best Supportive Care (BSC) Versus BSC Plus Placebo in Patients With Metastatic Carcinoma of the Kidney Which Has Progressed After Treatment With Sorafenib and/or Sunitinib
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 416
- Enrollment target
NCT00410124: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT00410124 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 416 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00410124, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 416 participants
- Enrollment target
Study Summary
To assess whether daily treatment with RAD001 could slow the growth and spread of metastatic carcinoma of the kidney. The safety of RAD001 was also to be studied in this trial.
Primary Outcome
Progression Free survival is defined as the time from randomization to the date of first documented disease progression or death from any cause. The primary statistical analysis of PFS was based on central radiological assessments using a one-sided stratified log-rank test. Radiological assessments: every 8 weeks (+/-1 week) during the first year and every 12 weeks (+/- 1 week) during the second year and thereafter and at the end of the study. Kaplan-Meier methodology was used to estimate the me
Interventions
- DRUG Placebo
- DRUG RAD001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 416 participants |
| Start Date | 2006-11 |
| Est. Completion | 2011-10 |
| Phase | Phase 3 |
What the finished NCT00410124 record still lists
NCT00410124 is an interventional study that assigns participants to a tested intervention. The registered 416 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 (46% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00410124 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00410124 about?
NCT00410124 is a clinical study titled "RAD001 Plus Best Supportive Care (BSC) Versus BSC Plus Placebo in Patients With Metastatic Carcinoma of the Kidney Which Has Progressed After Treatment With Sorafenib and/or Sunitinib". To assess whether daily treatment with RAD001 could slow the growth and spread of metastatic carcinoma of the kidney. The safety of RAD001 was also to be studied in this trial.
What is the current status of trial NCT00410124?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 416 participants. The study started on 2006-11. Estimated completion is 2011-10.
What interventions are being tested in trial NCT00410124?
The interventions under investigation include: Placebo (DRUG), RAD001 (DRUG).
Who is sponsoring clinical trial NCT00410124?
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 NCT00410124's enrollment target sits among peer trials
416 902nd of 2000 higher than 1,098 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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