Suspended
Open-Label Study of Abiraterone Acetate Plus Prednisone in Asymptomatic or Mildly Symptomatic Subjects With Metastatic Castration-Resistant Prostate Cancer
What is being tested
Abiraterone acetate
+ Prednisone or prednisolone
Drug
Who is eligible
Urogenital Diseases+7
+ Genital Diseases
+ Genital Diseases, Male
Over 18 Years
+27 Eligibility Criteria
How is it accessible
Suspended
Available upon a request by a licensed MDExpanded Access
Summary
Principal SponsorJanssen Research & Development, LLC
Last updated: November 7, 2018
Sourced from a government-validated database.Claim as a partner
This is an open-label (identity of assigned study drug will be known) early access protocol (EAP). Approximately 60 participants will be enrolled in this study. Participants will receive abiraterone acetate 1000 mg daily plus prednisone or prednisolone 5 mg daily. Treatment in 28-day cycles will continue until progression of clinical disease. Study drug will be provided until the company obtains market authorization and reimbursement in the participant countries for this indication.
Principal SponsorJanssen Research & Development, LLC
Last updated: November 7, 2018
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Male
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Urogenital DiseasesGenital DiseasesGenital Diseases, MaleGenital Neoplasms, MaleNeoplasmsNeoplasms by SiteProstatic DiseasesUrogenital NeoplasmsMale Urogenital DiseasesProstatic Neoplasms
Criteria
10 inclusion criteria required to participate
Adequate liver function according to protocol-defined parameters
Agrees to protocol-defined use of effective contraception
Be able to swallow the study drug whole as a tablet
Have Eastern Cooperative Oncology Group performance status of <= 2
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17 exclusion criteria prevent from participating
Eligible for another study of abiraterone acetate that is open to enrollment
Has a condition or situation which, in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with participant's participation in the study
Has a history of pituitary or adrenal dysfunction
Has active or symptomatic viral hepatitis or chronic liver disease
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Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 8 locations
Suspended8 Study Centers