Study Phase 2

An Observational Study of Continuous Oral Dosing of an Irreversible CYP17 Inhibitor, Abiraterone Acetate (CB7630), in Castration-Resistant Prostate Cancer Patients Evaluating Androgens and Steroid Metabolites in Bone Marrow Plasma

  • 1 CSR Summary Not Yet Avaiable
  • 1 NCT00544440
  • 1 Primary Citation Not Available
  • Data Specification Not Available

Trial Information

Generic NameAbiraterone acetateProduct NameZYTIGA®Therapeutic AreaCancers and Other NeoplasmsEnrollment57% FemaleN/A% WhiteN/A
Product ClassHormonesSponsor Protocol NumberCOU-AA-BMAData PartnerJohnson & JohnsonCondition StudiedNeoplasms, ProstaticMean/Median Age (Years)69.1

Supporting Documentation

  • Collected Datasets Available
  • Data Definition Specification Available
  • Protocol with Amendments Available
  • Statistical Analysis Plan Available
  • Clinical Study Report Available

Approved Data Requests Associated with this Trial

Disclaimer

Clinical study data provided through this site do not replace the official labeling of a given drug product, which presents benefits and risks of the product for approved use(s). Before prescribing any product, health care professionals should consult the current prescribing information approved in their country. Patients seeking information may consult with their health care professional about the product, for which health authority approved written patient information may be available.