Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| West China Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
This is a phase I study evaluating tolerability, pharmacokinetics, and preliminary efficacy of HC-1119 in patients with metastatic castration-resistant prostate cancer. The study objective is to study the tolerability, safety, and dose-limiting toxicities (DLT) of HC-1119 in patients with mCRPC.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dose group | Experimental | Drug name L:HC-1119 Dosage: 40 mg, 80 mg, 160 mg, and 200 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HC-1119 | Drug | oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicities(DLT) | Safety measures | From the first dose of the study to the 12th week after dose |
| Number of patients with adverse events | Safety measures | From the first dose of the study to the 12th week after dose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum drug concentration(Cmax) | Single-dose and repeated-dose | From the first dose of the study to the 12th week after dose |
| Time of maximum drug concentration(Tmax) | Single-dose and repeated-dose |
Not provided
Inclusion Criteria (those who meet all of the following are eligible):
Voluntarily participated in the study, with understanding of relevant study procedures and signed informed consent form;
Male , ≥18 years old;
With histologically or cytologically confirmed prostate cancer, without neuroendocrine carcinoma or ductal adenocarcinoma;
With evidence of metastatic disease (such as bone scan and CT/MRI results);
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: Serum 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 disease progression defined by PCWG2 with 2 or more new metastatic lesions on bone scan);
Castrate levels of testosterone (< 50 ng/dl) at screening;
Bilateral orchiectomy or ongoing androgen deprivation therapy with effective GnRH analogues;
Estimated life expectancy > 6 months;
ECOG performance status ≤ 1;
Laboratory tests must meet the following criteria:
Exclusion Criteria (those who meet any one of the following are ineligible):
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Feng Bi, professor | West China Hospital | Principal Investigator |
| Li Zheng, professor | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hinova Pharmaceuticals Inc. | Chengdu | Sichuan | 610041 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34109624 | Derived | Li X, Cheng K, Li X, Zhou Y, Liu J, Zeng H, Chen Y, Liu X, Zhang Y, Wang Y, Bi F, Zheng L. Phase I clinical trial of HC-1119: A deuterated form of enzalutamide. Int J Cancer. 2021 Oct 1;149(7):1473-1482. doi: 10.1002/ijc.33706. Epub 2021 Jul 7. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C540278 | enzalutamide |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| From the first dose of the study to the 12th week after dose |
| Area under curve from time 0 to 24h (AUC0-24h) | Single-dose and repeated-dose | From the first dose of the study to the 12th week after dose |
| Maximal PSA Response Rate | Percentage of patients with > 50% decrease in PSA levels from baseline during the 12-week treatment period | From the first dose of the study to the 12th week after dose |
| Response rate of prostate specific antigen (PSA) | Percentage of patients with > 50% decrease in PSA levels from baseline at weeks 6, 8, 10, and 12. | From the first dose of the study to the 12th week after dose |