Skip to main content

NCT01314118 - A Multicenter, Open-label, Single-arm, Phase 2 Study of Abiraterone Acetate Plus Prednisone in Subjects With Advanced Prostate Cancer Without Radiographic Evidence of Metastatic Disease

A Multicenter, Open-label, Single-arm, Phase 2 Study of Abiraterone Acetate Plus Prednisone in Subjects With Advanced Prostate Cancer Without Radiographic Evidence of Metastatic Disease


CSR Summary

Not Yet Available


Data Specification

Available upon data request approval


Annotated CRF

Available upon data request approval

Product Info

Generic Name
Abiraterone acetate
Product Name
ZYTIGA¬ģ
Therapeutic Area
Cancers and Other Neoplasms
Enrollment
131
% Female
0.0%
% White
82.4%
Product Class
Hormones
Sponsor Protocol Number
212082PCR2005
Data Partner
Johnson & Johnson
Condition Studied
Neoplasms, Prostatic
Mean/Median Age (Years)
72.0

Supporting Documentation

Clinical Study Report
Collected Datasets
Data Definition Specification
Annotated Case Report Form
Protocol with Amendments
Statistical Analysis Plan
Study Phase 
2
Additional Information: 

Please note: only primary analysis data (completed in 2013) are available for this study.

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.