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This study was to evaluate the safety and efficacy of dalcilide tablets in combination with AA-P in the treatment of subjects with high tumor burden mHSPC and to determine the second stage starting dose and progression-free survival(rPFS) based on BICR assessment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dalpiciclib+ abiraterone+ prednisone | Experimental |
| |
| placebo+abirarerone+prenisone | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dalpiciclib isethionate tablets; abiraterone acetate tablets; prednisone tablets | Drug | dalpiciclib+ abiraterone+ prednisone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event (AE) incidence | approximately 63 months |
| Measure | Description | Time Frame |
|---|---|---|
| PK: Steady-state trough concentrations of Dalsili and Abiraterone (Cmin, ss) | approximately 6 months | |
| rPFS | Time from randomisation to radiologically confirmed progressive disease or death due to any cause |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feng Liu | Contact | +86-18875033874 | feng.liu.fl10@hengrui.com |
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| placebo; abiraterone acetate tablets; prednisone tablets | Drug | placebo+abirarerone+prenisone |
|
| approximately 63 months |
| PSA response rate | In patients who had not started androgen deprivation prior to randomization, the proportion of patients whose PSA levels were ≥ 90% lower than baseline by the end of the study treatment week | approximately 63 months |
| ORR | Objective response rate+ The proportion of participants evaluated according to RECIST v1.1 and PCWG3 criteria that achieved predetermined tumor volume reduction and maintained the minimum duration was the sum of the proportion of complete and partial responses | approximately 63 months |
| Time to PSA progression | Time from randomisation to the first time of PSA progression | approximately 63 months |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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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