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NCT00631527 · ClinicalTrials.gov registry record · Phase 1
Sunitinib Malate, Hormone Ablation and Radiation Therapy in Patients With Prostate Cancer
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT00631527: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00631527 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00631527, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn the safety of adding 3 different dose-levels of Sutent® (sunitinib malate) to a combination of hormone therapy and radiation in patients with prostate cancer.
Primary Outcome
DLT defined as inability to complete the schedule course of radiation therapy for toxicity of any grade. If \< 2 patients in initial cohort of 6 experience DLT then a subsequent dose-level cohort initiated. If 2 or more patients in a cohort experience DLT then further accrual to that cohort curtailed and no higher dose level examined. Maximum tolerated dose (MTD) for oral sunitinib in combination with radiation and hormone ablation defined as highest dose level in which 6 patients have been trea
Interventions
- DRUG Goserelin
- RADIATION Radiation Therapy (RT)
- DRUG Leuprolide
- DRUG Sunitinib Malate
- DRUG Casodex
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2008-02 |
| Phase | Phase 1 |
What the finished NCT00631527 record still lists
NCT00631527 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 5 interventions - of which Goserelin is the first listed.
NCT00631527 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00631527 about?
NCT00631527 is a clinical study titled "Sunitinib Malate, Hormone Ablation and Radiation Therapy in Patients With Prostate Cancer". The goal of this clinical research study is to learn the safety of adding 3 different dose-levels of Sutent® (sunitinib malate) to a combination of hormone therapy and radiation in patients with prostate cancer.
What is the current status of trial NCT00631527?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2008-02.
What interventions are being tested in trial NCT00631527?
The interventions under investigation include: Goserelin (DRUG), Radiation Therapy (RT) (RADIATION), Leuprolide (DRUG), Sunitinib Malate (DRUG), Casodex (DRUG).
Who is sponsoring clinical trial NCT00631527?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00631527's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 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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