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This is a study for evaluating enzalutamide pharmacokinetics and pharmacodynamics, and related changes after drug switch in Chinese patients with metastatic castration-resistant prostate cancer. The study primary objective is to evaluate the pharmacokinetic characteristics of enzalutamide in Chinese patients with mCRPC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| enzalutamide | Experimental | 160mg |
|
| HC-1119 | Experimental | To be determined |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enzalutamide | Drug | oral |
| |
| HC1119 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum drug concentration(Cmax) | From the first dose of the study drug to 12 weeks after dose | |
| Time of maximum drug concentration(Tmax) | From the first dose of the study drug to 12 weeks after dose | |
| Area under curve from time 0 to 24h (AUC0-24h) | From the first dose of the study drug to 12 weeks after dose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum drug concentration(Cmax) | From 13 weeks to 24 weeks after dose | |
| Time of maximum drug concentration(Tmax) | From 13 weeks to 24 weeks after dose | |
| Area under curve from time 0 to 24h (AUC0-24h) |
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Inclusion Criteria:
Voluntarily participated in the study, with understanding of and will to comply with relevant study procedures and signed informed consent form;
Chinese male, ≥ 18 years old;
With histologically or cytologically confirmed prostate cancer, without neuroendocrine carcinoma or ductal adenocarcinoma;
With evidence of metastatic lesions (such as bone scan and CT/MRI);
Patients with relapsed, refractory, or progressive disease despite castration (surgery or chemical) or combined androgen deprivation therapy. (Progressive disease is defined as 1 or more of the following 3 criteria: PSA progression: A minimum of 3 rising PSA values with an interval of at least 1 week between determinations, resulting in a final value higher than 50% of the minimum, with a starting PSA value > 2 ng/ml; Soft tissue disease progression as defined by RECIST 1.1; Bone progression as defined by PCWG2 with 2 or more new lesions on bone scan);
Castrate levels of testosterone (< 50 ng/dl) at screening; bilateral orchiectomy or ongoing androgen deprivation therapy with effective GnRH analogues;
ECOG performance status ≤1;
Laboratory tests must meet the following criteria:
Estimated life expectancy > 6 months.
Exclusion Criteria:
Participated in other clinical drug trials within 1 month prior to screening, or the occurrence of toxicity caused by previous treatments that has not been relieved to ≤ Grade 2 toxicity (according to CTCAE 4.03) prior to enrollment;
Brain metastases;
Subjects are excluded if any of the following conditions are met:
Subjects are excluded if any of the following conditions regarding past or concomitant medication are met:
Known hypersensitivity to any ingredient of the study drugs (enzalutamide and HC-1119) or similar drugs;
HIV seropositive;
History of medication or drug abuse;
Other conditions that subject is determined by the investigator to be unsuitable for this study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Ethics Committee of Hunan Cancer Hospital | Changsha | China |
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| ID | Term |
|---|---|
| C540278 | enzalutamide |
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| Drug |
oral |
|
| From 13 weeks to 24 weeks after dose |
| Number of patients with adverse events | Safety measures | From the first dose of the study drug to 24 weeks after dose |
| Percentage of patients with > 50% decrease in prostate specific antigen (PSA) | Percentage of patients with > 50% decrease in PSA levels from baseline at weeks1,3,5 6, 8, 10, and 12. | From the first dose of the study drug to 12 weeks after dose |