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 : August 19, 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 :||March 31, 2022|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|