Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00313482 · ClinicalTrials.gov registry record · Phase 2
PII Trial of Docetaxel/Prednisone w/Sargramostim for HRPC
A Phase 2 study, sponsored by Veeda Oncology.
- Terminated
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
NCT00313482: Clinical Trial Phase 2 study, sponsored by Veeda Oncology.
NCT00313482 is a Phase 2 study that was terminated before completion, run by Veeda Oncology. The registered enrollment target is 35 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00313482, a Phase 2 study, was terminated before completion, sponsored by Veeda Oncology.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
Study Summary
This is a Phase II, open-label study in male patients with metastatic HRPC. Each cycle will be 21 days (3 weeks). Patients will receive the following drugs: * Docetaxel 75 mg/m2 IV given over 1 hour on Day 1. * Prednisone 5 mg orally twice daily beginning on Day 1 and continuing until disease progression. * Sargramostim 250 mcg/m2 SC on Days 2-15 of each cycle. Patients will be evaluated every 4 cycles (12 weeks) for response using RECIST criteria. PSA response will be evaluated according to the National Cancer Institute (NCI) PSA Working Group Criteria. To evaluate the safety of this drug combination, patients will be evaluated at each clinic visit for adverse events. Toxicities will be assessed per National Cancer Institute (NCI) CTCAE Version 3.0. Those patients achieving stable disease or better will continue therapy. Those patients experiencing progressive disease will be taken off study. Patients will receive a maximum of 10 cycles of treatment.
Interventions
- DRUG Docetaxel
- DRUG Prednisone
- DRUG Sargramostim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2006-04 |
| Est. Completion | 2008-08 |
| Phase | Phase 2 |
Why NCT00313482 stopped before completion
NCT00313482 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 3 interventions - of which Docetaxel is the first listed.
NCT00313482 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00313482 about?
NCT00313482 is a clinical study titled "PII Trial of Docetaxel/Prednisone w/Sargramostim for HRPC". This is a Phase II, open-label study in male patients with metastatic HRPC. Each cycle will be 21 days (3 weeks). Patients will receive the following drugs: * Docetaxel 75 mg/m2 IV given over 1 hour on Day 1. * Prednisone 5 mg orally twice daily beginning on Day 1 and continuing until disease prog...
What is the current status of trial NCT00313482?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2006-04. Estimated completion is 2008-08.
What interventions are being tested in trial NCT00313482?
The interventions under investigation include: Docetaxel (DRUG), Prednisone (DRUG), Sargramostim (DRUG).
Who is sponsoring clinical trial NCT00313482?
This trial is sponsored by Veeda Oncology, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00313482's enrollment target sits among peer trials
35 1524th of 2000 higher than 462 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01697371 · 35 participants · NA
Proton Therapy in the Treatment of Liver Metastases
- NCT01940757 · 35 participants · Phase 1
Experimental Infection of Hookworm-naïve Adults With Dermally-applied Infectious Necator Americanus Hookworm Larvae
- NCT02235857 · 35 participants · NA
Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in Children
- NCT02637934 · 35 participants · Phase 1
Phase I Pilot Study of Biodistribution, Metabolism and Excretion of Novel Radiotracer [18F]Fluorthanatrace (FTT) by PET/CT
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia