Ignite Creation Date:
2024-05-06 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06099990
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-25
First Post:
2023-10-13
Brief Title:
Dalpiciclib Isethionate Tablets Combined With Abiraterone Acetate Tablets I and Prednisone Tablets AA-P Versus Placebo Combined With AA-P in Treatment of High-volume Metastatic Hormone-sensitive Prostate Cancer mHSPC
Sponsor:
Jiangsu HengRui Medicine Co Ltd
Organization:
Jiangsu HengRui Medicine Co Ltd
Study Overview
Official Title:
A Multicenter Randomized Double-blind Phase IbIII Clinical Study of Dalpiciclib Isethionate Tablets Combined With Abiraterone Acetate Tablets I and Prednisone Tablets AA-P Versus Placebo Combined With AA-P in Treatment of High-volume Metastatic Hormone-sensitive Prostate Cancer mHSPC
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 survivalrPFS based on BICR assessment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None