Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Medical University of South Carolina
With
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
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
