Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04861181
Status:
RECRUITING
Last Update Posted:
2022-04-20
First Post:
2021-04-20
Brief Title:
NIRAPK Study of the Relationships Between Clinical Biological and Pharmacokinetic Metrics and Toxicities When Niraparib is Used as Maintenance Treatment for Ovarian Cancer Patients
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Study of the Relationships Between Clinical Biological and Pharmacokinetic Metrics and Toxicities When Niraparib is Used as Maintenance Treatment 300mg or 200 mgDay for Ovarian Cancer Patients
Status:
RECRUITING
Status Verified Date:
2022-04
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:
NIRAPK
Brief Summary:
Ovarian cancer is the seventh most common cancer in women worldwide and is the leading cause of gynecologic cancer deaths in high-income countries
Standard treatment for newly diagnosed advanced ovarian cancer consist of cytoreductive surgery and platinum-based chemotherapy with or without concurrent and maintenance bevacizumab a vascular endothelial growth factor VEGF inhibitor
A majority of women with epithelial ovarian cancer respond well to first-line platinum-based chemotherapy There is however a high rate of relapserecurrence disease progression ranging from 10 to 26 months
Poly ADP ribose polymerase inhibitors PARPi a new class of therapeutic molecules have recently revolutionized this paradigm demonstrating progression-free survival PFS advantages in several trials
The PARPi molecule Niraparib has obtained its market authorization after the NOVA trial as second maintenance treatment line irrespectively of patients BRCA-mutated gene or HR status
Since results of the Phase III trial PRIMA have demonstrated that Niraparib can also provided a significant PFS increase as first line maintenance treatment for adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian cancer who are in response complete response or partial response to platinum-based chemotherapy irrespectively of their BRCA-mutated gene or HR status
However despite its high therapeutic potential Niraparib at standard dose 200 or 300mgday is known to lead to hematologic toxicity andor nephrotoxicity This was demonstrated during the NOVA trial the dose of Niraparib having to be reduced in 80 of the patients to reduce toxicity
A retrospective study of the NOVA trial indicates that 2 predictive factors leading to hematologic toxicity were a weight 77kg and an initial platelet count 175 GL However it seems more complex as 50 of patients with an initial weight between 58 and 77kg have not reported thrombocytopenia Same for platelet count Creatinine clearance below 60mlmin and an hypoalbuminemia 35 gl have also been identified in another study as predictive factors to thrombocytopenia
The inter-individual heterogeneity in terms of toxicity regarding Niraparib is high and still not well understood
The aim of our study is therefore to better identify which clinical biological and pharmacokinetic metrics can be considered as toxicity induction causes when Niraparib is used as maintenance treatment 200 or 300mgday for ovarian cancer patients
Standard treatment for newly diagnosed advanced ovarian cancer consist of cytoreductive surgery and platinum-based chemotherapy with or without concurrent and maintenance bevacizumab a vascular endothelial growth factor VEGF inhibitor
A majority of women with epithelial ovarian cancer respond well to first-line platinum-based chemotherapy There is however a high rate of relapserecurrence disease progression ranging from 10 to 26 months
Poly ADP ribose polymerase inhibitors PARPi a new class of therapeutic molecules have recently revolutionized this paradigm demonstrating progression-free survival PFS advantages in several trials
The PARPi molecule Niraparib has obtained its market authorization after the NOVA trial as second maintenance treatment line irrespectively of patients BRCA-mutated gene or HR status
Since results of the Phase III trial PRIMA have demonstrated that Niraparib can also provided a significant PFS increase as first line maintenance treatment for adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian cancer who are in response complete response or partial response to platinum-based chemotherapy irrespectively of their BRCA-mutated gene or HR status
However despite its high therapeutic potential Niraparib at standard dose 200 or 300mgday is known to lead to hematologic toxicity andor nephrotoxicity This was demonstrated during the NOVA trial the dose of Niraparib having to be reduced in 80 of the patients to reduce toxicity
A retrospective study of the NOVA trial indicates that 2 predictive factors leading to hematologic toxicity were a weight 77kg and an initial platelet count 175 GL However it seems more complex as 50 of patients with an initial weight between 58 and 77kg have not reported thrombocytopenia Same for platelet count Creatinine clearance below 60mlmin and an hypoalbuminemia 35 gl have also been identified in another study as predictive factors to thrombocytopenia
The inter-individual heterogeneity in terms of toxicity regarding Niraparib is high and still not well understood
The aim of our study is therefore to better identify which clinical biological and pharmacokinetic metrics can be considered as toxicity induction causes when Niraparib is used as maintenance treatment 200 or 300mgday for ovarian cancer patients
Detailed Description:
None
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