Ignite Creation Date:
2024-05-06 @ 7:45 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06120972
Status:
RECRUITING
Last Update Posted:
2024-02-07
First Post:
2023-11-01
Brief Title:
Upfront Maintenance Olaparib in Advanced Ovarian Cancer BRCAwt Patients With Known Homologous Recombination Deficiency
Sponsor:
Alexander B Olawaiye MD
Organization:
University of Pittsburgh
Study Overview
Official Title:
A Non-randomized Prospective Phase II Study of Upfront Maintenance Olaparib in Advanced Ovarian Cancer BRCAwt Patients With Known Homologous Recombination Deficiency
Status:
RECRUITING
Status Verified Date:
2024-02
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 is a prospective non-randomized efficacy trial of olaparib maintenance therapy after frontline treatment with platinum-based therapy in advanced ovarian cancer patients with BRCAwt homologous recombination deficient HRD disease
Detailed Description:
The use of PARP inhibitors has revolutionized how we think of the BRCA mutated population of ovarian cancer patients However this population with BRCA mutation is not the only one with homologous recombination deficiencies HRD Examples of BRCAwt but HR deficient mutations HRD include BRIP1 RAD51CD and CHEK2 as well as epigenetic changes like BRCA methylation This study is designed to provide information on if BRCAwt HRD patients with advanced ovarian cancer benefit from maintenance olaparib monotherapy after frontline treatment PAOLA-1 showed that this population had improved PFS from the addition of olaparib to bevacizumab but there is currently no information on how this population does with olaparib alone For this reason a similar population to PAOLA-1 will be used in this study This study is designed to fill an important gap in the data provided by PAOLA-1 It is now considered standard of care for patients with BRCAwt HRD disease to receive maintenance PARPi either alone eg niraparib based of PRIMA or in combination with bevacizumab based of PAOLA-1 Therefore there is little to no concern that patients will be missing out on potentially beneficial therapy that could impact their prognosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None