The purpose of this study is to evaluate pharmacokinetics (PK) following a single dose and multiple dose treatment and the safety of apalutamide in Chinese participants with metastatic castration resistant prostate cancer (mCRPC) at dose of 240 milligram (mg).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
The participants will receive apalutamide 240 mg once daily orally.
Peking University Third Hospital
Beijing, China
Beijing Cancer Hospital of Peking University
Beijing, China
Jiangsu Cancer Hospital
Nanjing, China
Fudan Cancer Hospital
Shanghai, China
Plasma Concentration of Apalutamide
Plasma concentration of apalutamide will be reported.
Time frame: Predose; postdose up to 168 hours (hrs) (Cycle1 Day 7), Cycle 2 (pre-dose; on Day 1 and 15 of cycle 2) and Cycle 3 (pre-dose; up to 24 hrs post-dose). Each cycle is of 28 days
Number of Participants with Adverse Events
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Time frame: Up to 30 days of last study treatment (approximately 18 months)
Change from Baseline in Serum Prostate Specific Antigen (PSA) at Weeks 4 and 12
Change from baseline in serum PSA levels will be determined.
Time frame: Baseline, at Weeks 4 and 12 or earlier for those who discontinue therapy (up to approximately 4 months).
Maximal Decline in Prostate Specific Antigen
Maximal decline in PSA levels will be determined.
Time frame: Up to 30 days of last study treatment (approximately 18 months)
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