Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06572735
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Study on the Relative Dose Intensity of PARP Inhibitors in Real-life on a Population of Patients Over 70 Years With Advanced Ovarian Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Study on the Relative Dose Intensity of PARP Inhibitors in Real-life on a Population of Patients Over 70 Years With Advanced Ovarian Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PARIB-OLD-PRO²
Brief Summary:
PolyADP-ribose polymerase PARP inhibitors are anti-cancer treatments that induce preferential tumor cell death Their efficacy has been demonstrated in many tumor models primarily in advanced ovarian cancer PARP inhibitors also exhibit a particular toxicity damaging the hematopoietic tissue With age pharmacokinetic changes or a reduction in medullary cavity may increase these toxicities and may lead to dose reductionspostponements or premature discontinuation of PARP inhibitors which may impact the efficacy of treatment Close biological monitoring must be carried out to limit these toxicities in most cases anemia thrombocytopenia and neutropenia Until now the geriatric factors impacting the tolerance and uptake of PARP inhibitors in the elderly patient population with advanced ovarian cancer are not clearly established It is therefore necessary to have prospective real-life data in order to support patients in a decision-making process on whether or not to continue such treatments
PARIB-OLD-PRO² will evaluate the association between various clinical biological and geriatric factors and the relative dose intensity RDI of therapy by PARP inhibitors This is a prospective multicenter longitudinal and non-interventional study and will involve a population of 50 patients aged 70 years and elder with advanced ovarian cancer who are scheduled to start a therapy with PARP inhibitors for the first time The aim of the study is to better understand the effects of PARP inhibitors on a elderly population knowledge of the genetic and clinical determinants of PARP inhibitors toxicity in this specific population and an optimal management of this therapy related adverse events in order to maintain an RDI
PARIB-OLD-PRO² will evaluate the association between various clinical biological and geriatric factors and the relative dose intensity RDI of therapy by PARP inhibitors This is a prospective multicenter longitudinal and non-interventional study and will involve a population of 50 patients aged 70 years and elder with advanced ovarian cancer who are scheduled to start a therapy with PARP inhibitors for the first time The aim of the study is to better understand the effects of PARP inhibitors on a elderly population knowledge of the genetic and clinical determinants of PARP inhibitors toxicity in this specific population and an optimal management of this therapy related adverse events in order to maintain an RDI
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None