A lower dose olaparib (Lynparza®), combined with a drug which inhibits olaparib degradation, to increase tolerability and decrease the price of the treatment with olaparib

Phase 1

• Conditions: Ovarian cancer; MedDRA version: 20.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-004032-28-NL
• Lead Sponsor: Radboud University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-24
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Part A – proof of concept
•Subjects who start or are on treatment with olaparib tablets 300mg BID, 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 128
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32

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 clinical trial of medicinal product
• Study Design: Not specified