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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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower). 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).
Primary Outcome
A single-course MTD is defined as the dose level having mean posterior dose limiting toxicity probability closest to 25%.
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 |
What the finished NCT00059631 record still lists
NCT00059631 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 2 interventions - of which Mitoxantrone (Novantrone) is the first listed.
NCT00059631 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00059631's enrollment target sits among peer trials
42 1105th of 2000 higher than 876 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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