Ignite Creation Date:
2024-05-06 @ 2:59 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04486937
Status:
UNKNOWN
Last Update Posted:
2020-07-27
First Post:
2020-07-20
Brief Title:
SC10914 Monotherapy for the mCRPC With gs BRCA Mutation
Sponsor:
Jiangxi Qingfeng Pharmaceutical Co Ltd
Organization:
Jiangxi Qingfeng Pharmaceutical Co Ltd
Study Overview
Official Title:
Sc10914 Monotherapy for Metastatic Castration Resistant Prostate Cancer Patients With Germ and or Somatic BRCA Mutation a Single Arm Multicenter Clinical Tria
Status:
UNKNOWN
Status Verified Date:
2020-07
Last Known Status:
NOT_YET_RECRUITING
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:
mCRPC
Brief Summary:
This study is a multicenter single arm phase I II clinical study in mCRPC subjects who failed to receive docetaxel chemotherapy abitolone acetate and or enzalutamide including its analogues for the treatment of BRCA mutations in germ cells and or somatic cells
Detailed Description:
The subjects oral administration sc10914 tablets 400mg on an empty stomach three times a day for 28 consecutive days as a treatment cycle until disease progression PD according to Recist11 and the adjusted PCWG3 standard the subjects met the imaging CT MRI bone scan PD standard or the toxicity was intolerable
The study is divided into two stages in the first stageenrolled 36 patients whose response can be evaluated if there are at least 7 cases of objective remission CR or PR the second stage is allowed otherwise the study will be stopped in the second stage the number of subjects whose response can be evaluated is planned to continue to be enrolled to 70 casesstage 1 and stage 2
The study is divided into two stages in the first stageenrolled 36 patients whose response can be evaluated if there are at least 7 cases of objective remission CR or PR the second stage is allowed otherwise the study will be stopped in the second stage the number of subjects whose response can be evaluated is planned to continue to be enrolled to 70 casesstage 1 and stage 2
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