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NCT00392821 · ClinicalTrials.gov registry record · Phase 1
Dosing and Effectiveness Study of Sorafenib and RAD001 in the Treatment of Patients With Advanced Kidney Cancer
A Phase 1 study, sponsored by SCRI Development Innovations.
- Completed
- Registry status
- Phase 1
- Development phase
- 78
- Enrollment target
NCT00392821: Completed Phase 1 study, sponsored by SCRI Development Innovations.
NCT00392821 is a Phase 1 study that has completed, run by SCRI Development Innovations. The registered enrollment target is 78 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00392821, a Phase 1 study, has completed, sponsored by SCRI Development Innovations.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 78 participants
- Enrollment target
Study Summary
This study is being done in 2 parts. The first part is to determine the dose of RAD001 that should be used in combination with sorafenib. The second part is using the above determined dose of RAD001 in combination with sorafenib to see how effective these 2 drugs are against advanced kidney cancer. Participants will be asked to keep a pill diary.
Primary Outcome
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = Percentage of Patients Who Experience an Objective Response (CR+ PR) to Treatment. In oncology, this outcome measure is reported for all patients treated at the same dose level and is not separated
Interventions
- DRUG Sorafenib
- DRUG RAD001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2006-12 |
| Est. Completion | 2013-10 |
| Phase | Phase 1 |
What the finished NCT00392821 record still lists
NCT00392821 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% higher).
The record links to 0 conditions, and to 2 interventions - of which Sorafenib is the first listed.
NCT00392821 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00392821 about?
NCT00392821 is a clinical study titled "Dosing and Effectiveness Study of Sorafenib and RAD001 in the Treatment of Patients With Advanced Kidney Cancer". This study is being done in 2 parts. The first part is to determine the dose of RAD001 that should be used in combination with sorafenib. The second part is using the above determined dose of RAD001 in combination with sorafenib to see how effective these 2 drugs are against advanced kidney cancer. ...
What is the current status of trial NCT00392821?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 78 participants. The study started on 2006-12. Estimated completion is 2013-10.
What interventions are being tested in trial NCT00392821?
The interventions under investigation include: Sorafenib (DRUG), RAD001 (DRUG).
Who is sponsoring clinical trial NCT00392821?
This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00392821's enrollment target sits among peer trials
78 697th of 2000 higher than 1,298 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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