drugset / Trial / NCT00059631
Phase I Study of Weekly Intravenous PS-341 (Bortezomib) Plus Mitoxantrone
Phase 1
Completed
42 enrolled
M.D. Anderson Cancer Center
Millennium Pharmaceuticals, Inc. · collabNational Cancer Institute (NCI) · collab
NaSingle-groupOpen-labelTreatment
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).
Timeline
- Start
- 2003-03-20
- Primary completion
- 2015-06-17
- Completion
- 2015-06-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 1.4 mg/m2 | Intravenous |
| Subject | Mitoxantrone | Small molecule | 3 mg/m2 | Intravenous |