Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06180356
Status:
RECRUITING
Last Update Posted:
2024-02-21
First Post:
2023-12-01
Brief Title:
Niraparib Rechallenge After Surgery in Ovarian Cancer Patients With Oligometastatic Progression
Sponsor:
MedSIR
Organization:
MedSIR
Study Overview
Official Title:
Phase II Study to Assess the Efficacy of Niraparib Rechallenge After Surgery in Ovarian Cancer Patients With Oligometastatic Progression The ANALLISA Study
Status:
RECRUITING
Status Verified Date:
2023-12
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:
ANALLISA
Brief Summary:
The ANALLISA study is a fast proof-of-concept phase II clinical trial which aims to assess the efficacy of niraparib rechallenge treatment after secondary cytoreductive surgery in ovarian cancer OC patients with oligometastatic progression OMP after first maintenance therapy with any PARP inhibitor A total of 30 patients with OC and OMP will be enrolled and will receive treatment with niraparib 300 or 200 mg according to body weight or platelet count Patients will start treatment within 6 weeks after surgery and will receive it until progressive disease or treatment discontinuation The main purpose of the study is to evaluate progression-free survival PFS of niraparib rechallenge in OC patients with OMP and no residual disease after secondary cytoreductive surgery
Detailed Description:
This is a single-arm phase II clinical trial which will enroll female patients aged 18 years with high grade serous or endometrioid ovarian cancer OC who have had an oligometastatic progression OMP during or after the first maintenance therapy with any poly adenosine diphosphate ADP ribose polymerase inhibitor PARPi OMP is defined as 1-5 metastatic lesions Patients with symptomatic metastatic disease are not eligible
A total of 30 patients with OC and OMP will be enrolled and will receive treatment with niraparib 300 or 200 mg according to body weight or platelet count Patients will start treatment within 6 weeks after surgery and will receive it until progressive disease or treatment discontinuation
The main objective of the study is to evaluate progression-free survival PFS of niraparib rechallenge in OC patients with OMP and no residual disease after secondary cytoreductive surgery Main secondary objectives are to assess the PFS according to biomarker status BRCAm BRCAwt HRD and HRP the PFS by CA 125 the second progression-free survival PFS2 the time to start of first subsequent therapy or death TFST and the overall survival OS
A total of 30 patients with OC and OMP will be enrolled and will receive treatment with niraparib 300 or 200 mg according to body weight or platelet count Patients will start treatment within 6 weeks after surgery and will receive it until progressive disease or treatment discontinuation
The main objective of the study is to evaluate progression-free survival PFS of niraparib rechallenge in OC patients with OMP and no residual disease after secondary cytoreductive surgery Main secondary objectives are to assess the PFS according to biomarker status BRCAm BRCAwt HRD and HRP the PFS by CA 125 the second progression-free survival PFS2 the time to start of first subsequent therapy or death TFST and the overall survival OS
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