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

Phase 4

Recruiting

• Conditions: ovarian cancer; Ovarian carcinoma; 10033283

• Registration Number: NL-OMON54399
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 160

Inclusion Criteria

Part A - proof of concept
• Subjects who start or are on treatment with olaparib tablets, according to
the drug label and physician*s discretion;
• Subjects who are able and willing to provide written informed consent prior
to screening;
• Age of 18 years or older;
• Able to measure the outcome of the study in this subject (e.g. patient
availability; willing and being able to undergo repeated plasma sample
collection);
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Part B - clinical evaluation
• Subjects who start on treatment with olaparib tablets, according to the drug
label and physician*s discretion;
• Subjects who are able and willing to provide written informed consent prior
to screening;
• Age of 18 years or older;
• Able to measure the outcome of the study in this subject (e.g. patient
availability; willing and being able to undergo sample collection for PK and PD
purposes);
• Expected to be on olaparib treatment for >= 3 months;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.

Exclusion Criteria

Part A + B
• Concurrent use of other anti-cancer therapies;
• Concurrent use of potent inducers or inhibitors of CYP3A4 as assessed with
the KNMP *G-standaard*;
• Known contra-indications for treatment with cobicistat in line with the
summary of product characteristics;

Study & Design

• Study Type: Interventional
• Study Design: Not specified