NCT06572735

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: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: Female
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

Poly(ADP-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 reductions/postponements 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.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
OTHER	QoL surveys	2 quality of life surveys (OV28 and ELD14) will be completed by patients every 3 months during a 12-month period
OTHER	Geriatric assessment (G-CODE)	A geriatric assessment (G-CODE) will be performed by the research staff every 3 months during a 12-month period
BIOLOGICAL	Blood sampling	A supplementary volume of blood will be collected from a routine blood sample (8 mL) at 3 different time points : one at inclusion, one 6 and 12 months after the beginning of PARP inhibitors treatment. Genetic lab test will be performed to assess whether there is a specific genetic signature for PARP inhibitors toxicity.

Timeline

• Start date: 2024-09-24
• Primary completion: 2028-01-23
• Completion: 2028-01-23
• First posted: 2024-08-27
• Last updated: 2026-02-23

Locations

16 sites across 1 country: France

Regulatory

• FDA-regulated drug study