Pharmacokinetic boosting of olaparib to improve exposure, tolerance and cost-effectiveness (PROACTIVE-study)

Status

Not yet recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516414-38-00

Enrollment

Registered

2024-10-01

Start date

Unknown

Completion date

Unknown

Last updated

2025-07-24

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

Conditions

Cancer

Brief summary

Part A: AUC0-12h for the regular and boosted olaparib will be determined using noncompartmental analysis for the primary objective. Hereto, multiple PK samples will be collected after one week of each treatment regimen at the following times: pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8 hours after olaparib intake. If possible, additional PK samples will be taken after 10 and 12 hours., Part B: The number of patients who require a dose reduction due to toxicity will be registered.

Interventions

DRUGCOBICISTAT

DRUGOLAPARIB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Part A: AUC0-12h for the regular and boosted olaparib will be determined using noncompartmental analysis for the primary objective. Hereto, multiple PK samples will be collected after one week of each treatment regimen at the following times: pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8 hours after olaparib intake. If possible, additional PK samples will be taken after 10 and 12 hours., Part B: The number of patients who require a dose reduction due to toxicity will be registered.	—

Measure

Time frame

—

Countries

Netherlands

Outcome results

None listed

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