The investigational drug Abiraterone, designed for the treatment of men with advanced prostate cancer who have failed chemotherapy has not yet been approved by the FDA. Because of the extraordinarily positive results that were obtained on the phase III trials (which were stopped early because of these fantastic results) the pharmaceutical manufacturer of the drug has worked with the FDA to allow an expanded access, compassionate usage program while formal approval of the FDA is pending.
The following web page describes the program:
This website https://malecare.org is designed for health care professionals to learn more about an expanded access program (EAP) to provide subjects with the opportunity for treatment with an investigational drug, abiraterone acetate, before Marketing Authorization. Abiraterone acetate is an investigational drug and is not currently approved by the Food and Drug Administration (FDA). The safety and efficacy of abiraterone acetate has not been fully established or thoroughly evaluated by regulatory agencies. In accordance with local regulations, the EAP is either run as a clinical trial or on a named patient basis in a particular country.
Subjects with metastatic, castration-resistant prostate cancer (mCRPC) who have progressed after treatment with taxane-based chemotherapy may be eligible to receive investigational drug based on certain criteria.
This EAP is available to subjects who (not all criteria are listed):
• Are males age 18 or older
• Have histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
• Received at least one, but not more than two cytotoxic chemotherapy regimens for mCRPC. At least one regimen must have contained a taxane such as docetaxel
• Have had progressive disease according to Prostate Cancer Working Group 2 (PCWG2) Criteria
This EAP is not available to subjects who (not all criteria are listed):
• Do not have metastatic disease which has become resistant to conventional hormone therapy
• Have serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
• Have active or symptomatic viral hepatitis, chronic liver disease, or moderate to severe hepatic function abnormality
• Have a history of pituitary or adrenal dysfunction
• Have poorly controlled or uncontrolled hypertension
• Have uncorrected hypokalemia (low serum levels of potassium)
Subjects will receive an investigational treatment, abiraterone acetate 1,000 mg orally/once daily (administered as four 250 mg tablets) and prednisone or prednisolone 5 mg orally/ twice a day. Subjects will be treated until disease progression.
Additional information about this study may also be found at www.clinicaltrials.gov.
This EAP is available in the following countries: United States
212072PCR3001 Open Study Sites
Study sites conducting the 212PCR3001 study are located in the following areas. To learn more about a study center, please contact the Customer Communications Center at (800) 457?6399 or MedInfo@CentocorOrthoBiotech.com.
United States of America
Marina Del Rey, California
Santa Rosa, California
Boca Raton, Florida
Palm Beach Gardens, Florida
Morristown, New Jersey
East Setauket, New York
I am anticipating that the number of sites which will be authorized to participate in the program will grow.
If you are interested in participating in the program have your doctor contact the Customer Communications Center at (800) 457?6399 or MedInfo@CentocorOrthoBiotech.com.
Joel T Nowak, M.A., M.S.W.