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NCT00879333 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of RAD001 (Everolimus) Monotherapy Plus Best Supportive Care in Patients With Advanced Gastric Cancer (AGC)
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 656
- Enrollment target
NCT00879333: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT00879333 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 656 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00879333, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 656 participants
- Enrollment target
Study Summary
This study is designed to assess the safety and efficacy of RAD001 monotherapy in patients with advanced gastric cancer which has progressed after one or two lines of prior chemotherapy.
Primary Outcome
The primary objective of this study was to compare OS between everolimus + best supportive care (BSC) and placebo + BSC. OS, was defined as the time from date of randomization to the date of death due to any cause. If at the analysis cut-off date a patient was not known to have died, survival was censored at the date of the last contact. OS was analyzed using the Kaplan Meier estimates method.
Interventions
- DRUG Everolimus
- DRUG Best Supportive Care (BSC)
- DRUG Everolimus placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 656 participants |
| Start Date | 2009-07 |
| Est. Completion | 2014-01 |
| Phase | Phase 3 |
What the finished NCT00879333 record still lists
NCT00879333 is an interventional study that assigns participants to a tested intervention. The registered 656 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 (15% lower).
The record links to 0 conditions, and to 3 interventions - of which Everolimus is the first listed.
NCT00879333 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00879333 about?
NCT00879333 is a clinical study titled "Safety and Efficacy of RAD001 (Everolimus) Monotherapy Plus Best Supportive Care in Patients With Advanced Gastric Cancer (AGC)". This study is designed to assess the safety and efficacy of RAD001 monotherapy in patients with advanced gastric cancer which has progressed after one or two lines of prior chemotherapy.
What is the current status of trial NCT00879333?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 656 participants. The study started on 2009-07. Estimated completion is 2014-01.
What interventions are being tested in trial NCT00879333?
The interventions under investigation include: Everolimus (DRUG), Best Supportive Care (BSC) (DRUG), Everolimus placebo (DRUG).
Who is sponsoring clinical trial NCT00879333?
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 NCT00879333's enrollment target sits among peer trials
656 565th of 2000 higher than 1,436 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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