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NIRAPK : Study of the relationships between pharmacokinetic properties (PK) and hematological toxicity of niraparib in ovarian cancer

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513856-14-00
Acronym
69HCL20_0989
Enrollment
42
Registered
2024-07-10
Start date
2021-05-05
Completion date
2025-04-17
Last updated
2024-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with high-grade serous epithelial ovarian, tubal or primary peritoneal cancers

Brief summary

Identification of clinical/biological/pharmacokinetic/therapeutic factors leading to hematological and/or renal toxicology(s).

Detailed description

Relation of the average pharmacokinetic parameters observed in patients according to the clinical/biological/therapeutic and dietary parameters studied., Relationship between the pharmacokinetic parameters measured and the PFS at 24 months., Creation of predictive models using logistic models or PK-PD models with direct or indirect effects., Measurement of quality of life and correlation with observed toxicities.

Interventions

Sponsors

Hospices Civils De Lyon
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Identification of clinical/biological/pharmacokinetic/therapeutic factors leading to hematological and/or renal toxicology(s).

Secondary

MeasureTime frame
Relation of the average pharmacokinetic parameters observed in patients according to the clinical/biological/therapeutic and dietary parameters studied., Relationship between the pharmacokinetic parameters measured and the PFS at 24 months., Creation of predictive models using logistic models or PK-PD models with direct or indirect effects., Measurement of quality of life and correlation with observed toxicities.

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026