Ignite Creation Date:
2024-05-06 @ 3:14 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04566952
Status:
UNKNOWN
Last Update Posted:
2020-10-30
First Post:
2020-09-24
Brief Title:
Anlotinib Combined With Dose-reduced Olaparib in Patients With Platinum-Sensitive Recurrent Ovarian Cancer
Sponsor:
Xiaoxiang Chen
Organization:
Jiangsu Cancer Institute Hospital
Study Overview
Official Title:
A Prospective Single-arm Single-center Exploratory Phase II Study to Evaluate the Efficacy and Safety of Anlotinib Combined With Dose-reduced Olaparib in Patients With Platinum-Sensitive Recurrent Ovarian Cancer
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
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:
ANLOLA
Brief Summary:
PARP inhibitors have changed the treatment paradigm of ovarian cancer Most patients using PARPpoly-ADP ribose polymerase inhibitors will suffer different grades of adverse eventsAEs followed by dose reduction It has not been reported whether the dose-reduced olaparib as maintenance treatment have an impact on efficacy Both PAOLA-1 and AVANOVA 2 studies showed that combined PARP inhibitors and antiangiogenic drugs have synergistic anti-tumor effect Anlotinib is a novel multi-target tyrosine kinase inhibitor that can inhibit VEGFRvascular endothelial growth factor receptor FGFRfibroblast growth factor receptor PDGFRplatelet-derived growth factor receptor αβ c-Kit and Ret And anlotinib has been approved as orphan drug designations for treatment of ovarian cancer by FDA in 2015 Previous studies showed that anlotinib had manageable toxicity and promising antitumor effect Our study is expected to investigate the efficacy and safety of anlotinib combined with dose-reduced olaparib as maintenance treatment in platinum-sensitive recurrent ovarian cancer patients
Detailed Description:
This study is a single-arm single-center exploratory phase II study to observe the efficacy and safety of anlotinib combined with dose-reduced olaparib in patients with platinum-sensitive recurrent ovarian cancer fallopian tube cancer and primary peritoneal cancer We will enroll the subjects who are treated with olaparib as maintenance treatment followed by dose reduction due to adverse events The primary end points are progression free survival and adverse events The secondary end points include objective response rate disease control rate overall survival time from enrollment to first subsequent treatment 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