Ignite Creation Date:
2024-07-17 @ 11:15 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06500247
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-06-27
Brief Title:
Darxicilib Combined With Abiraterone Acetate Tablets II for the Treatment of Advanced Metastatic Castration-resistant Prostate Cancer
Sponsor:
Qilu Hospital of Shandong University
Organization:
Qilu Hospital of Shandong University
Study Overview
Official Title:
A Prospective Exploratory Phase II Study on the Treatment of Advanced Metastatic Castration-resistant Prostate Cancer With Darxicilib in Combination With Abiraterone Acetate II
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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 is a single-arm multicenter phase II exploratory trial The purpose is to explore the efficacy and safety of Darxicilib in combination with Abiraterone Acetate for the treatment of subjects with metastatic castration-resistant prostate cancerThe main questions it aims to answer are
PSA50 response rate at the end of week 12
Participants will
Darxicilib 125mg per tablet oral administration once daily for 21 consecutive days followed by a 7-day break
Abiraterone Acetate tablets II 300mg per dose oral administration once daily for a 28-day cycle
Prednisone 5mg per tablet oral administration twice daily
PSA50 response rate at the end of week 12
Participants will
Darxicilib 125mg per tablet oral administration once daily for 21 consecutive days followed by a 7-day break
Abiraterone Acetate tablets II 300mg per dose oral administration once daily for a 28-day cycle
Prednisone 5mg per tablet oral administration twice daily
Detailed Description:
1 This research constitutes a phase II single-arm multicenter exploratory study aimed at assessing the therapeutic efficacy and safety profile of the combination therapy involving Darxicilib and Abiraterone Acetate II in patients diagnosed with metastatic castration-resistant prostate cancer mCRPC The enrollment target is set at 43 participants who meet the eligibility criteria for the efficacy assessment phase of the trial
2 1Main Research Objective To evaluate the efficacy of the treatment modality of Darxicilib in combination with Abiraterone Acetate II in patients with mCRPC metastatic castration-resistant prostate cancer
2Secondary Research Objectives
1 To assess the efficacy of the combination therapy in target mCRPC subjects through the time to PSA progression PSA response rate at 12 weeks PSA50 PSA90 and PSA 02 ngml disease-free survival PFS rates at 6 and 12 months overall survival OS and duration of response DOR
2 To evaluate the safety of the combination therapy for target mCRPC by assessing the incidence of adverse events time to pain progression and time to symptom progression
3Exploratory Research Objective Quality of life
2 1Main Research Objective To evaluate the efficacy of the treatment modality of Darxicilib in combination with Abiraterone Acetate II in patients with mCRPC metastatic castration-resistant prostate cancer
2Secondary Research Objectives
1 To assess the efficacy of the combination therapy in target mCRPC subjects through the time to PSA progression PSA response rate at 12 weeks PSA50 PSA90 and PSA 02 ngml disease-free survival PFS rates at 6 and 12 months overall survival OS and duration of response DOR
2 To evaluate the safety of the combination therapy for target mCRPC by assessing the incidence of adverse events time to pain progression and time to symptom progression
3Exploratory Research Objective Quality of life
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