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NCT00059631 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of Weekly Intravenous PS-341 (Bortezomib) Plus Mitoxantrone
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
NCT00059631: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00059631 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 42 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00059631, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
Study Summary
Primary Objective: -Establish the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of weekly mitoxantrone in combination with weekly PS-341 in patients with advanced AI-PCa. Secondary objectives: * Evaluate the effect of bortezomib and mitoxantrone in combination on PSA levels among patients with baseline PSA levels \>/=5 ng/mL who are treated near the maximum tolerated dose. * Monitor the effect of escalating doses of bortezomib combined with mitoxantrone on selected parameters of clinical benefit (i.e. performance status, tumor-related symptoms, measurable disease response).
Interventions
- DRUG Mitoxantrone (Novantrone)
- DRUG Bortezomib (PS-341)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2003-03-20 |
| Est. Completion | 2015-06-17 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00059631
The ClinicalTrials.gov registry entry for NCT00059631 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Mitoxantrone (Novantrone) is the first listed.
NCT00059631 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00059631 about?
NCT00059631 is a clinical study titled "Phase I Study of Weekly Intravenous PS-341 (Bortezomib) Plus Mitoxantrone". Primary Objective: -Establish the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of weekly mitoxantrone in combination with weekly PS-341 in patients with advanced AI-PCa. Secondary objectives: * Evaluate the effect of bortezomib and mitoxantrone in combination on PSA levels among ...
What is the current status of trial NCT00059631?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2003-03-20. Estimated completion is 2015-06-17.
What interventions are being tested in trial NCT00059631?
The interventions under investigation include: Mitoxantrone (Novantrone) (DRUG), Bortezomib (PS-341) (DRUG).
Who is sponsoring clinical trial NCT00059631?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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