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NCT00831792 · ClinicalTrials.gov registry record · Phase 2
TKI258 in Castrate Resistant Prostate Cancer
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
NCT00831792: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00831792 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 46 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00831792, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if a decrease in the levels of prostate specific antigen (PSA) may be linked with the status of prostate cancer that has spread to the bones. Researchers also want to learn how changes in your blood PSA level might affect the rebuilding of healthy bones while you are being treated with TKI258 for prostate cancer.
Primary Outcome
Three consecutive PSA elevations above nadir or baseline are required for progression. Each increment in PSA should be a minimum of 1 ng/ml and at least 2 weeks apart or will not count. The time of PSA progression will be taken as the time of the first of these PSA elevations that represents an increment by at least 25% above the nadir or baseline. Given that increments in PSA do not always represent treatment failure, particularly when novel agents with uncertain effects on PSA levels are being
Interventions
- DRUG TK1258
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2010-04-07 |
| Est. Completion | 2017-06-12 |
| Phase | Phase 2 |
What the finished NCT00831792 record still lists
NCT00831792 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 1 intervention - of which TK1258 is the first listed.
NCT00831792 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00831792 about?
NCT00831792 is a clinical study titled "TKI258 in Castrate Resistant Prostate Cancer". The goal of this clinical research study is to learn if a decrease in the levels of prostate specific antigen (PSA) may be linked with the status of prostate cancer that has spread to the bones. Researchers also want to learn how changes in your blood PSA level might affect the rebuilding of healthy...
What is the current status of trial NCT00831792?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2010-04-07. Estimated completion is 2017-06-12.
What interventions are being tested in trial NCT00831792?
The interventions under investigation include: TK1258 (DRUG).
Who is sponsoring clinical trial NCT00831792?
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 NCT00831792's enrollment target sits among peer trials
46 1286th of 2000 higher than 705 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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