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NCT00299741 · ClinicalTrials.gov registry record · Phase 2
Study of SU11248 in Men With Advanced Prostate Cancer
A Phase 2 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT00299741: Completed Phase 2 study, sponsored by Massachusetts General Hospital.
NCT00299741 is a Phase 2 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00299741, a Phase 2 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study Summary
* There are nearly 30,000 deaths per year in the United States from prostate cancer, making this a large and important target patient population for new cancer treatments. * SU011248 is an exciting, new, experimental drug that inhibits a number of proteins, or more specifically receptor tyrosine kinases, in tumor cells. These proteins are active in cellular pathways that are important for development and growth of a variety of different cancers. The targets of SU011248 include the receptors for vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF), and others. By blocking the VEGF and PDGF pathways, SU011248 can induce death of the blood vessels that nourish the cancer cells and death of the cancer cells themselves. * SU011248 has demonstrated significant anti-tumor activity in renal cell carcinoma, gastrointestinal stromal tumors, and other cancers. Its effect against prostate cancer has not been studied to date. * This study is directed at two populations of men with advanced prostate cancer: 1. Men with advanced prostate cancer who have a rising PSA despite hormone therapy, but have not yet received any chemotherapy. 2. Men with metastatic prostate cancer who have received prior chemotherapy (with a docetaxel-based regimen) and have increasing disease following chemotherapy. * Men in this study will receive SU011248 on a six-week repeating schedule, with four weeks of daily treatment followed by a two-week rest. The goals of the study are: 1. to determine whether SU011248 is an important therapeutic agent in men with advanced prostate cancer, and 2. to identify predictive markers of anti-cancer activity within individual subjects that would allow selective treatment of appropriate subjects in the future.
Primary Outcome
Prostate specific antigen (PSA) responses, defined as the number of men who exhibit PSA decline of at least 50% that is confirmed by a second PSA value 4 or more weeks later (PSA Working Group I Criteria)
Interventions
- DRUG Sunitinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2006-03 |
| Est. Completion | 2008-06 |
| Phase | Phase 2 |
What the finished NCT00299741 record still lists
NCT00299741 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 1 intervention - of which Sunitinib is the first listed.
NCT00299741 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00299741 about?
NCT00299741 is a clinical study titled "Study of SU11248 in Men With Advanced Prostate Cancer". * There are nearly 30,000 deaths per year in the United States from prostate cancer, making this a large and important target patient population for new cancer treatments. * SU011248 is an exciting, new, experimental drug that inhibits a number of proteins, or more specifically receptor tyrosine kin...
What is the current status of trial NCT00299741?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2006-03. Estimated completion is 2008-06.
What interventions are being tested in trial NCT00299741?
The interventions under investigation include: Sunitinib (DRUG).
Who is sponsoring clinical trial NCT00299741?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00299741's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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