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NCT00402415 · ClinicalTrials.gov registry record · Phase 1
Study of Combination of Sirolimus and Sutent in Patients With Advanced Solid Tumors Non-Curable With Standard Therapy
A Phase 1 study, sponsored by Yale University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT00402415: Clinical Trial Phase 1 study, sponsored by Yale University.
NCT00402415 is a Phase 1 study that was terminated before completion, run by Yale University. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00402415, a Phase 1 study, was terminated before completion, sponsored by Yale University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
There are two drugs involved in this study. Sunitinib (Sutent(R)) is approved by the Food and Drug Administration (FDA) for the treatment of advanced renal cell (kidney) cancer and gastrointestinal stromal tumors. Sunitinib is thought to work by blocking the growth of blood vessels into tumors; reducing the blood supply to tumors can slow their growth and sometimes causes the tumors to shrink. Sirolimus has been approved by the FDA to prevent the body from rejecting organ transplants. Sirolimus is being tested for its effects against cancer because it can slow the growth of some tumors in animal models. Sirolimus is thought to slow cancer growth in these animal models both by direct effects on the tumor cells, and also by blocking production of growth factors that stimulate production of blood vessels. We hope that the combined use of these two drugs will have better anti-cancer effects than either agent alone. This study is designed to find out if different doses of Sirolimus combined with a standard dose of Sutent are safe and well tolerated. Additionally, it is hoped to gain knowledge about the way that Sutent(R) in combination with sirolimus affects the blood vessels produced by cancer.
Interventions
- DRUG Rapamycin
- DRUG Sunitinib malate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2006-02 |
| Est. Completion | 2008-07 |
| Phase | Phase 1 |
Why NCT00402415 stopped before completion
NCT00402415 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Rapamycin is the first listed.
NCT00402415 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00402415 about?
NCT00402415 is a clinical study titled "Study of Combination of Sirolimus and Sutent in Patients With Advanced Solid Tumors Non-Curable With Standard Therapy". There are two drugs involved in this study. Sunitinib (Sutent(R)) is approved by the Food and Drug Administration (FDA) for the treatment of advanced renal cell (kidney) cancer and gastrointestinal stromal tumors. Sunitinib is thought to work by blocking the growth of blood vessels into tumors; redu...
What is the current status of trial NCT00402415?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2006-02. Estimated completion is 2008-07.
What interventions are being tested in trial NCT00402415?
The interventions under investigation include: Rapamycin (DRUG), Sunitinib malate (DRUG).
Who is sponsoring clinical trial NCT00402415?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00402415's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 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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