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Study of Abiraterone Acetate in Patients With Advanced Prostate Cancer

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ClinicalTrials.gov Identifier: NCT01217697
Expanded Access Status : Approved for marketing
First Posted : October 8, 2010
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Tracking Information
First Submitted Date October 7, 2010
First Posted Date October 8, 2010
Last Update Posted Date March 24, 2017
 
Descriptive Information
Brief Title Study of Abiraterone Acetate in Patients With Advanced Prostate Cancer
Brief Summary The purpose of this study is to collect additional safety information on abiraterone acetate administered with prednisone to patients with metastatic castration-resistant prostate cancer (CRPC).
Detailed Description This is a study to collect information on adverse events (side effects) that occur during treatment with abiraterone acetate in patients with metastatic castration-resistant prostate cancer (CRPC). To participate in this study patients must have failed 1 or 2 chemotherapy regimens (1 of which contained a taxane such as docetaxel), reside in an area where abiraterone acetate is not yet available through local healthcare providers, and not be eligible for enrollment in any other ongoing clinical research study of abiraterone acetate. CRPC is progressive form of prostate cancer where the cancer cells become resistant to hormonal therapies that are designed to block the release or uptake of testosterone and the cancer cells metastasize (ie, spread to other parts of the body). Abiraterone acetate (referred to as abiraterone) is a drug currently under development for use in treating men with CRPC. Patients will be treated with abiraterone and prednisone daily until progression of clinical disease (ie, includes signs of clinical disease progression and/or clinical disease progression confirmed by radiographic and prostate-specific antigen [PSA] test results). Other reasons for discontinuation of treatment may include adverse events reported, initiation of other anticancer therapies, or the patient's inability to comply with dosing instructions. Patients will be followed for 30 days after the discontinuation of treatment with abiraterone acetate. Patients will take four 250-mg tablets of abiraterone orally at least 1 hour before a meal or 2 hours after a meal any time up to 10 pm every day. Patients will also take 5 mg of oral prednisone, twice daily. Each treatment cycle consists of 28 days and patients will take abiraterone continually on a daily basis until disease progression is observed at which time abiraterone will be discontinued and the dose of prednisone reduced if clinically indicated.
Study Type Expanded Access
Intervention
  • Drug: Abiraterone Acetate
    Abiraterone acetate, type=equal, unit=mg, number=250, form=tablet, route=oral use, 4 tablets once daily.
  • Drug: Prednisone\Prednisolone
    Participants will receive prednisone 5 mg twice daily as oral tablet OR prednisolone 5 mg (if prednisone is not available).
Publications * Sternberg CN, Castellano D, Daugaard G, Géczi L, Hotte SJ, Mainwaring PN, Saad F, Souza C, Tay MH, Garrido JM, Galli L, Londhe A, De Porre P, Goon B, Lee E, McGowan T, Naini V, Todd MB, Molina A, George DJ; Abiraterone Global EAP Investigators. Abiraterone acetate for patients with metastatic castration-resistant prostate cancer progressing after chemotherapy: final analysis of a multicentre, open-label, early-access protocol trial. Lancet Oncol. 2014 Oct;15(11):1263-8. doi: 10.1016/S1470-2045(14)70417-6. Epub 2014 Sep 18. Erratum in: Lancet Oncol. 2014 Nov;15(12):e528.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Approved for marketing
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia,   Brazil,   Canada,   Colombia,   Croatia,   Czech Republic,   Denmark,   Greece,   Hong Kong,   Hungary,   Indonesia,   Korea, Republic of,   Malaysia,   Mexico,   New Zealand,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Singapore,   Spain,   Taiwan,   Thailand,   United States
Removed Location Countries India
 
Administrative Information
NCT Number NCT01217697
Responsible Party Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Sponsor Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators Not Provided
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PRS Account Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Verification Date March 2017