Phase I Study of Weekly Intravenous PS-341 (Bortezomib) Plus Mitoxantrone
Status:
Completed
Trial end date:
2015-06-17
Target enrollment:
Participant gender:
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).
Phase:
Phase 1
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborators:
Millennium Pharmaceuticals, Inc. National Cancer Institute (NCI)