Open-label, phase I, pharmacokinetic studies of abiraterone acetate in healthy men
نویسندگان
چکیده
منابع مشابه
Comparison of a Novel Formulation of Abiraterone Acetate vs. the Originator Formulation in Healthy Male Subjects: Two Randomized, Open-Label, Crossover Studies
BACKGROUND AND OBJECTIVE Abiraterone acetate is approved for the treatment of metastatic castration-resistant prostate cancer. The originator abiraterone acetate (OAA) formulation is poorly absorbed and exhibits large pharmacokinetic variability in abiraterone exposure. Abiraterone acetate fine particle (AAFP) is a proprietary formulation (using SoluMatrix Fine Particle Technology™) designed to...
متن کاملPhase II Trial of Abiraterone Acetate Plus Prednisone in Black Men With Metastatic Prostate Cancer
LESSONS LEARNED The safety and activity findings of abiraterone acetate plus prednisone treatment in black men with mCRPC were similar to results from previously conducted studies with largely white populations.Poor trial accrual continues to be a challenge in black men with mCRPC and further efforts are needed to address such underrepresentation. BACKGROUND Self-identified black men have hig...
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BACKGROUND Gastroprotective agents are recommended for patients receiving low-dose aspirin (LDA) or nonsteroidal anti-inflammatory drugs (NSAIDs). Vonoprazan is a potassium-competitive acid blocker recently approved for the prevention of peptic ulcer recurrence in patients receiving LDA or NSAIDs. METHODS This phase 2, open-label, single-center study in healthy Japanese males evaluated drug-d...
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PURPOSE AT-101 binds and inhibits the antiapoptotic function of Bcl-2, Bcl-xL, Mcl-1, and Bcl-w and is a potent stimulator of proapoptotic proteins. In this multi-institution phase I/II trial, we evaluated the safety and efficacy of single-agent AT-101, in men with chemotherapy naïve, castrate-resistant prostate cancer (CRPC). EXPERIMENTAL DESIGN Patients with progressive CRPC were to be trea...
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BACKGROUND Live attenuated influenza vaccines (LAIV) against a variety of strains of pandemic potential are being developed and tested. We describe the results of an open-label phase I trial of a live attenuated H2N2 virus vaccine. OBJECTIVES To evaluate the safety, infectivity, and immunogenicity of a live attenuated H2N2 influenza virus vaccine. PARTICIPANTS/METHODS The A/Ann Arbor/6/60 (...
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ژورنال
عنوان ژورنال: Cancer Chemotherapy and Pharmacology
سال: 2012
ISSN: 0344-5704,1432-0843
DOI: 10.1007/s00280-012-1865-3