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NCT00879619 · ClinicalTrials.gov registry record · Phase 1
Taxotere/Prednisone Plus Sunitinib in Chemotherapy-Naïve, Hormone Refractory Prostate Cancer Patients
A Phase 1 study, sponsored by John P. Fruehauf.
- Terminated
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT00879619: Clinical Trial Phase 1 study, sponsored by John P. Fruehauf.
NCT00879619 is a Phase 1 study that was terminated before completion, run by John P. Fruehauf. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00879619, a Phase 1 study, was terminated before completion, sponsored by John P. Fruehauf.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving docetaxel and prednisone together with sunitinib malate may kill more tumor cells. PURPOSE: This pilot phase I/II trial studies the side effects and best way to give docetaxel and prednisone together with sunitinib malate and to see how well it works in treating patients with prostate cancer that progressed after hormone therapy.
Primary Outcome
Defined by \>= 30% decline in PSA from baseline for at least 3 months during study entry. Response rates will be expressed with two-sided exact binomial confidence intervals. Significance of changes between pre- and after-treatment PSA or testosterone will be determined by the Wilcoxon signed-rank test. Associations between PSA response and tumor response will also be examined by Fisher's exact test.
Interventions
- DRUG prednisone
- DRUG docetaxel
- DRUG sunitinib malate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2009-07 |
| Est. Completion | 2011-11 |
| Phase | Phase 1 |
Why NCT00879619 stopped before completion
NCT00879619 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 3 interventions - of which prednisone is the first listed.
NCT00879619 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00879619 about?
NCT00879619 is a clinical study titled "Taxotere/Prednisone Plus Sunitinib in Chemotherapy-Naïve, Hormone Refractory Prostate Cancer Patients". RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth...
What is the current status of trial NCT00879619?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2009-07. Estimated completion is 2011-11.
What interventions are being tested in trial NCT00879619?
The interventions under investigation include: prednisone (DRUG), docetaxel (DRUG), sunitinib malate (DRUG).
Who is sponsoring clinical trial NCT00879619?
This trial is sponsored by John P. Fruehauf, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00879619's enrollment target sits among peer trials
4 1995th of 2000 higher than 2 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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