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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 is a Phase 2 study that was terminated before completion, run by Veeda Oncology. The registered enrollment target is 35 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00313482
The ClinicalTrials.gov registry entry for NCT00313482 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Veeda Oncology, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Docetaxel is the first listed.
NCT00313482 reports 0 study locations.
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.
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