Phase I/II Study of Abiraterone Acetate and Prednisone in Combination With Cabazitaxel in Patients With Metastatic Castrate Resistant Prostate Cancer That is Refractory to Docetaxel
Abiraterone acetate and cabazitaxel have been approved by the United States Food and Drug
Administration (FDA) to treat prostate cancer that has spread to other parts of the body
such as the lymph nodes or bone. These drugs are approved individually for use when the
cancer has become resistant to other treatments, including chemotherapy with docetaxel. The
combination of these two drugs has not been approved, so the research team will study the
safety and effectiveness of the combination.
Patients are being asked to participate in this study because their tumor has grown or
spread during therapy. Patients may benefit from a new combination of drugs to treat it.
Abiraterone acetate and prednisone have been shown to prevent the growth of prostate cancer
cells by lowering the level of testosterone in the blood. It works in different areas of
the body to block the production of this hormone that signals the cancer cells to grow.
Cabazitaxel and prednisone prevent cancer cells from growing by blocking certain structures
from functioning properly in the cell. These structures help cells divide and therefore
grow. By blocking their function, the cell will not be able to divide and will die.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and efficacy of Cabazitaxel in combination with Abiraterone acetate and Prednisone
Phase I dose escalation portion: To determine the maximum tolerated dose, dose limiting toxicities, safety, and recommended phase 2 dose of cabazitaxel, administered as a single intravenous dose every 3 weeks, in combination with abiraterone acetate and prednisone taken daily, to patients with castrate-resistant prostate cancer. Phase II portion: To assess the anti-cancer efficacy of the combination in patients with Castrate Resistant Prostate Cance (CRPC), as determined by a prostatic specific antigen (PSA) decline of 50% or more from baseline during the first 6 cycles (18 weeks), measured every 3 weeks while on study.
Every 3 weeks for duration of study treatment
Yes
Elaine Lam, MD
Principal Investigator
University of Colorado, Denver
United States: Institutional Review Board
13-1489.cc
NCT01845792
July 2013
July 2019
Name | Location |
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University of Colorado Cancer Center | Denver, Colorado 80262 |