Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Bavituximab

Antineoplastic Agents, Immunological

Cabazitaxel (25 mg/m2) will be administered IV on Day 1 of each 21-day treatment cycle. Bavituximab (3 mg/kg) will be administered as an IV infusion on a weekly basis (Cycle 1 Day 2, all other cycles Day 1; day 8; day 15) for 8 cycles.

Cabazitaxel (25 mg/m2) will be administered IV on Day 1 of each 21-day treatment cycle, and bavituximab (3 mg/kg) will be administered as an IV infusion on a weekly basis (Cycle 1 Day 2, all other cycles Day 1; day 8; day 15) for 8 cycles.

Cabazitaxel plus bavituximab

Michael Lilly, MD

This is a Phase Ib/IIa Study of Cabazitaxel plus Bavituximab in patients with castration-resistant prostate cancer (CRPC). The current study is designed to determine if the addition of bavituximab to cabazitaxel will improve progression free survival (PFS) or overall survival (OS). In addition, the Lead Researcher is requiring the collection of urine, and blood specimens for future research.

This study will enroll patients with CRPC, who have been previously treated with docetaxel or a docetaxel-containing regimen. Patients may be intolerant of, or resistant to, docetaxel, or may have been previously treated with the agent without definite disease progression during therapy.

Patients must meet the study eligibility criteria and must be competent to give informed consent.

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

Ph Ib/IIa Study of Cabazitaxel Plus Bavituximab in Castration-resistant Prostate Cancer

Phase Ib/IIa Study of Cabazitaxel Plus Bavituximab for Patients With Castration-resistant Prostate Cancer Previously Treated With Chemotherapy

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.

To estimate the PSA response rate from cabazitaxel + bavituximab therapy in CRPC patients previously treated with docetaxel. PSA response rate will be assessed at multiple time points during the 24 wks of study treatment.

To estimate the objective response rate from cabazitaxel + bavituximab therapy in CRPC patients previously treated with docetaxel. Objective response rate will be assessed at day 85, 169

To estimate the overall survival in subjects with CRPC (previously treated with docetaxel) following cabazitaxel + bavituximab therapy. Overall survival will be assessed continually during the duration of the study.

To document the toxicity of cabazitaxel + bavituximab therapy in CRPC patients previously treated with docetaxel. Toxicity will be assessed continually during the 24 wks of study therapy.

Determination of progression-free survival in subjects treated with cabazitaxel + bavituximab for CRPC previously treated with docetaxel. PFS will be assessed continually during the entire study.

Peregrine Pharmaceuticals

Medical University of South Carolina

Cabazitaxel (25 mg/m2) will be administered IV on Day 1 of each 21-day treatment cycle. Bavituximab (3 mg/kg) will be administered as an IV infusion on a weekly basis (Cycle 1 Day 2, all other cycles Day 1; day 8; day 15) for 8 cycles.

Cabazitaxel plus bavituximab: Cabazitaxel (25 mg/m2) will be administered IV on Day 1 of each 21-day treatment cycle, and bavituximab (3 mg/kg) will be administered as an IV infusion on a weekly basis (Cycle 1 Day 2, all other cycles Day 1; day 8; day 15) for 8 cycles.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Ph Ib/IIa Study of Cabazitaxel Plus Bavituximab in Castration-resistant Prostate Cancer	NCT01335204	Prostate Cancer Prostatic Neopl...	Cabazitaxel plu...	18 Years -	Medical University of South Carolina
Ph Ib/IIa Study of Cabazitaxel Plus Bavituximab in Castration-resistant Prostate Cancer	NCT01335204	Prostate Cancer Prostatic Neopl...	Cabazitaxel plu...	18 Years -	Medical University of South Carolina

Spots Global Cancer Trial Database for cabazitaxel plus bavituximab