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The purpose of this study was to observe and evaluate the tolerability, safety, and pharmacokinetics of HRS-1167 combined with abiraterone acetate tablets (II) and prednisone in patients with metastatic prostate cancer, determine the RP2D, and evaluate the effectiveness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-1167 combined with abiraterone acetate tablets (II) and prednisone | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-1167 tablets | Drug | HRS-1167 tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicity (DLT) | 28 days | |
| Recommended phase II dose (RP2D) | 28 days | |
| The dose suspension rate caused by drug-related adverse events | 2 years | |
| The dose downregulation rate caused by drug-related adverse events | 2 years | |
| The dose termination rate caused by drug-related adverse events | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| PSA response rate | 1 year | |
| Time to PSA progression as assessed by the investigator | 1 year | |
| Objective response rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ke Liu, M.M | Contact | 0518-81220121 | ke.liu.kl53@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital Of Anhui Medical University | Recruiting | Hefei | Anhui | 230000 | China |
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| Abiraterone Acetate tablets(II) | Drug | Abiraterone Acetate tablets(II) |
|
| Prednisone Acetate tablets | Drug | Prednisone Acetate tablets |
|
| 1 year |
| Disease control rate (DCR) | 1 year |
| Duration of response (DoR) | 1 year |
| Time to remission (TTR) | 1 year |
| Radiographic progression-free survival (rPFS) | 1 year |
| Overall survival (OS) | 3 years |
| Steady-state peak concentration (Cmax,ss) of HRS-1167 | 16 weeks |
| Adverse events | 2 years |
| 12-lead electrocardiogram | 2 years |
| ECOG score | 2 years |
| Steady-state peak time (Tmax,ss) of HRS-1167 | 16 weeks |
| Steady-state valley concentration (Cmin,ss) | 16 weeks |
| Steady-state area under the concentration-time curve (AUCss) | 16 weeks |
| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | 410000 | China |
|
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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