Trial Increased Primary Objective: August 2013 212082PCR2008 exposure with To establish the safety food An Open-Label profile of oral abiraterone Study to acetate and oral prednisone Determine the following short-term Short-Term administration after Safety of standardized low-fat or Continuous high-fat meals to subjects Dosing of with metastatic Abiraterone prostate cancer Acetate and (mCRPC) Prednisone in Secondary Objective: Modified Fasting and Fed States to To evaluate the exposure to Subjects With abiraterone following Metastatic administration of oral abiraterone acetate in the modified fasting state and Prostate Cancer. after standardized low-fat Protocol or high-fat meals to subjects available with mCRPC Trial Use in patients Protocol not available but March 2013 212082PCR1004 with study is nearly complete. moderate/severe Severe hepatic hepatic impairment impairment and (single dose PK chronic liver trial). Protocol disease not available Trials: Use in non-White Multiple (see individual patients study protocols) 212082PCR3001 Q4, 2014 212082JPN102 Dec 2012 212082PCR2007 Jun 2014 ABI-PRO-3001 Dec 2015 ABI-PRO-3002 Sep 2013 OPR reviewer’s comments in regard to the pharmacovigilance plan (PP) and the appropriateness of milestones The sponsor mainly plans routine pharmacovigilance activities. Only some safety concerns have been assigned an additional activity. The sponsor’s proposed pharmacovigilance activities and milestones were considered to be acceptable. All relevant studies were ongoing at the time of this evaluation. The available study protocols submitted were considered to be acceptable in regard to the assigned safety concern for RMP purposes.
Trial 212082PCR2008 An Open-Label Study to Determine the Short-Term Safety of Continuous Dosing of Abiraterone Acetate and Prednisone in Modified Fasting and Fed States to Subjects With Metastatic Prostate Cancer. Protocol available Increased exposure with food Primary Objective: To establish the safety profile of oral abiraterone acetate and oral prednisone following short-term administration after standardized low-fat or high-fat meals to subjects with metastatic prostate cancer (mCRPC) Secondary Objective: To evaluate the exposure to abiraterone following administration of oral abiraterone acetate in the modified fasting state and after standardized low-fat or high-fat meals to subjects with mCRPC August 2013 Trial 212082PCR1004 Severe hepatic impairment (single dose PK trial). Protocol not available Use in patients with moderate/severe hepatic impairment and chronic liver disease Protocol not available but study is nearly complete. March 2013 Trials: 212082PCR3001 212082JPN102 212082PCR2007 ABI-PRO-3001 ABI-PRO-3002 Use in non-White patients Multiple (see individual study protocols) Q4, 2014 Dec 2012 Jun 2014 Dec 2015 Sep 2013 OPR reviewer’s comments in regard to the pharmacovigilance plan (PP) and the appropriateness of milestones The sponsor mainly plans routine pharmacovigilance activities. Only some safety concerns have been assigned an additional activity. The sponsor’s proposed pharmacovigilance activities and milestones were considered to be acceptable. All relevant studies were ongoing at the time of this evaluation. The available study protocols submitted were considered to be acceptable in regard to the assigned safety concern for RMP purposes.
auspar-abiraterone-acetate-140122.docx