Phase Ib/IIa Study of Cabazitaxel Plus Bavituximab for Patients With Castration-resistant Prostate Cancer Previously Treated With Chemotherapy
Cabazitaxel will be administered IV on day 1 of each 21-day treatment cycle. Bavituximab (3
mg/kg) will be administered as an intravenous (IV) infusion on a weekly basis (Cycle 1 Day
2, all other cycles Day 1; day 8, day 15). Patients will receive cabazitaxel (day 1) plus
bavituximab weekly of each 21-day cycle for up to 8 cycles.
Up to 31 patients will be enrolled to ensure 28 evaluable subjects. The accrual period is
expected to be between 12 to 18 months (1-1.5 years).
Subjects will remain on the treatment phase of the study until any of the following events
occur:
- Disease progression as evidenced by an increase in the prostate-specific antigen (PSA)
level, worsening of pain, or disease progression by Response Evaluation Criteria in
Solid Tumors (RECIST)
- Completion of 8 cycles of cabazitaxel-bavituximab therapy (day 169)
- Development of toxicity that, in the investigator's judgment, precludes further study
participation
- Significant protocol violations or noncompliance on the part of the patient or
investigator
- The investigator's judgment that discontinuation is in the patient's best interest
- Initiation of alternative antineoplastic treatments.
- Refusal of the patient to continue treatment or follow-up
- Loss to follow-up
After completion of the treatment phase, subjects will remain on the followup phase of the
study until any of the following events occur:
- Refusal of the patient to continue treatment or follow-up
- Loss to follow-up
- Death
- The investigator's judgment that discontinuation is in the patient's best interest
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Probability of progression-free survival at day 85
The primary objective of this study is to determine the probability of progression-free survival (PFS) after 12 weeks of therapy in subjects with CRPC treated with cabazitaxel + bavituximab.
12 weeks
Yes
Michael Lilly, MD
Principal Investigator
Medical University of South Carolina
United States: Food and Drug Administration
MUSC 101637
NCT01335204
June 2011
March 2013
Name | Location |
---|---|
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |