Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2026-02-20 @ 12:54 PM
Study NCT ID:
NCT02736305
Status:
COMPLETED
Last Update Posted:
2022-06-13
First Post:
2015-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Regorafenib in Recurrent Epithelial Ovarian Cancer
Sponsor:
National Cancer Centre, Singapore
Organization:
Study Overview
Official Title:
An Open-Label, Single-Arm Phase 2 Clinical Trial Of Regorafenib in Patients With Multiply Recurrent Epithelial Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2022-06
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:
Regorafenib is an oral multikinase inhibitor that blocks the activity of kinases involved in angiogenesis (VEGFR 1,2,3 and TEK), oncogenesis (KIT, Ret Proto-Oncogene (RET), Raf-1 Proto-Oncogene, Serine/Threonine Kinase (RAF1) and BRAF) and tumour growth (PDGFR and FGFR). Epithelial ovarian cancer (EOC) cell lines frequently express high levels of vascular endothelial growth factor (VEGF) and in vivo preclinical studies evaluating Regorafenib have shown promising activity in ovarian cancer. In the clinic, anti-angiogenesis therapy with bevacizumab (a monoclonal antibody to VEGF) has already emerged as an important cornerstone in the management of ovarian cancer both as part of frontline adjuvant treatment and as second-line therapy for platinum-sensitive recurrent disease. Whilst Regorafenib has been FDA approved for the treatment of patients with metastatic colorectal cancer who have failed prior bevacizumab, it's role in the management of ovarian cancer remains to be defined.
Detailed Description:
STUDY OBJECTIVES
The objective of this study is to evaluate the efficacy and safety of regorafenib at a dose of 120mg daily for 21 days out of every 28 day cycle in Asian females with multiply recurrent EOC.
Primary Endpoint:
Investigator assessed progression free survival (PFS)
Secondary Endpoints:
The objective of this study is to evaluate the efficacy and safety of regorafenib at a dose of 120mg daily for 21 days out of every 28 day cycle in Asian females with multiply recurrent EOC.
Primary Endpoint:
Investigator assessed progression free survival (PFS)
Secondary Endpoints:
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: