A Study of Androgen Receptor (AR) Antagonist Apalutamide in Chinese Participants With Metastatic Castration-Resistant Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT03523442|
Recruitment Status : Active, not recruiting
First Posted : May 14, 2018
Last Update Posted : May 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Neoplasms||Drug: Apalutamide||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of Androgen Receptor (AR) Antagonist Apalutamide in Chinese Subjects With Metastatic Castration-Resistant Prostate Cancer|
|Actual Study Start Date :||August 31, 2018|
|Estimated Primary Completion Date :||October 31, 2019|
|Estimated Study Completion Date :||December 30, 2020|
Participants will receive a single oral dose of apalutamide 240 milligram (mg) during pharmacokinetics (PK) Week Day 1 and will be monitored for one week (that is; PK Week) to assess PK and safety of drug. Subsequently, participants will further receive daily treatment of apalutamide from Cycle 1 Day 1 onwards until disease progression, withdrawal of consent, lost to follow-up, or the occurrence of unacceptable toxicity. Each treatment cycle consists of 28 days.
The participants will receive apalutamide 240 mg once daily orally.
Other Name: JNJ-56021927
- Plasma Concentration of Apalutamide [ 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 ]Plasma concentration of apalutamide will be reported.
- Number of Participants with Adverse Events [ Time Frame: Up to 30 days of last study treatment (approximately 18 months) ]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.
- Change from Baseline in Serum Prostate Specific Antigen (PSA) at Weeks 4 and 12 [ Time Frame: Baseline, at Weeks 4 and 12 or earlier for those who discontinue therapy (up to approximately 4 months). ]Change from baseline in serum PSA levels will be determined.
- Maximal Decline in Prostate Specific Antigen [ Time Frame: Up to 30 days of last study treatment (approximately 18 months) ]Maximal decline in PSA levels will be determined.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523442
|Peking University Third Hospital|
|Beijing, China, 100083|
|Beijing Cancer Hospital of Peking University|
|Beijing, China, 100142|
|Jiangsu Cancer Hospital|
|NanJing, China, 210000|
|Fudan Cancer Hospital|
|ShangHai, China, 200032|
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|