Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2026-01-05 @ 5:09 PM
Study NCT ID:
NCT04983550
Status:
UNKNOWN
Last Update Posted:
2021-07-30
First Post:
2021-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of SG001 Combined With PLD in Patients With Platinum-resistant Relapsed EOC
Sponsor:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Organization:
Study Overview
Official Title:
A Multicenter, Randomized, Controlled, Open-label, Phase II Study to Evaluate the Efficacy and Safety of SG001 in Combination With PLD in Patients With Platinum-resistant Relapsed Epithelial Ovarian Cancer
Status:
UNKNOWN
Status Verified Date:
2021-07
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:
None
Brief Summary:
This study is a multicenter, randomized, controlled, open-label, phase II study to evaluate the efficacy and safety of SG001 in combination with doxorubicin hydrochloride liposome injection in patients with platinum-resistant relapsed epithelial ovarian cancer.
Detailed Description:
This is a multicenter, randomized, controlled, open-label, phase II clinical study to evaluate the efficacy and safety of SG001 in combination with doxorubicin hydrochloride liposome injection in patients with platinum-resistant relapsed intermediate to advanced epithelial ovarian cancer, and to provide a basis for recommending the SG001 combination dosing regimen for subsequent studies. This study will enroll patients with histologically or cytologically confirmed epithelial ovarian, fallopian tube, or peritoneal cancer, FIGO stage II-IV, platinum-resistant relapse (defined as disease progression within 6 months after the last platinum-containing chemotherapy) and non-platinum refractory (defined as disease progression within 4 weeks after the first platinum-containing chemotherapy) with up to three prior lines of platinum-containing systemic chemotherapy, up to two lines of platinum-free systemic chemotherapy, and at least one measurable tumor lesion (according to RECIST 1.1).
Study Oversight
Has Oversight DMC:
False
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?: