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NCT01385059 · ClinicalTrials.gov registry record · Phase 2
Axitinib Before Surgery in Treating Patients With High-Risk Prostate Cancer
A Phase 2 study, sponsored by City of Hope Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT01385059: Completed Phase 2 study, sponsored by City of Hope Medical Center.
NCT01385059 is a Phase 2 study that has completed, run by City of Hope Medical Center. The registered enrollment target is 11 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01385059, a Phase 2 study, has completed, sponsored by City of Hope Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
This randomized phase II trial studies how well axitinib works in treating patients with high-risk prostate cancer before undergoing surgery. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving axitinib before surgery may make the tumor smaller and reduce the amount of normal cells that have to be removed
Primary Outcome
The niche density is defined as the average number of VEGF receptor 1 (VEGFR1) clusters in 8 distinct 40X microscopic fields in the regional lymph nodes of patients. We will use a two sample student's T-test to compare the primary endpoint of pre-metastatic niche density in the patients treated with axitinib, as compared to the pre-metastatic niche density in the patients enrolled on the control arm.
Interventions
- OTHER laboratory biomarker analysis
- DRUG axitinib
- PROCEDURE therapeutic conventional surgery
- OTHER enzyme-linked immunosorbent assay
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2011-10-28 |
| Est. Completion | 2013-10-09 |
| Phase | Phase 2 |
What the finished NCT01385059 record still lists
NCT01385059 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 4 interventions - of which laboratory biomarker analysis is the first listed.
NCT01385059 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01385059 about?
NCT01385059 is a clinical study titled "Axitinib Before Surgery in Treating Patients With High-Risk Prostate Cancer". This randomized phase II trial studies how well axitinib works in treating patients with high-risk prostate cancer before undergoing surgery. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving axitinib before surgery may make the tumor smaller ...
What is the current status of trial NCT01385059?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2011-10-28. Estimated completion is 2013-10-09.
What interventions are being tested in trial NCT01385059?
The interventions under investigation include: laboratory biomarker analysis (OTHER), axitinib (DRUG), therapeutic conventional surgery (PROCEDURE), enzyme-linked immunosorbent assay (OTHER).
Who is sponsoring clinical trial NCT01385059?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01385059's enrollment target sits among peer trials
11 1967th of 2000 higher than 33 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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