Cobicistat for Ovarian cancer|Cancer

Inclusion criteria

• {"criterion_text":"- Part A: Subjects who start or are on treatment with olaparib tablets, according to the drug label and physician’s discretion."}
• {"criterion_text":"- Part A+B: Subjects who are able and willing to provide written informed consent prior to screening;"}
• {"criterion_text":"- Part A: 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)."}
• {"criterion_text":"- Part A+B: Age of 18 years or older."}
• {"criterion_text":"- Part A: Eastern Cooperative Oncology Group (ECOG) performance status of 0-1."}
• {"criterion_text":"- Part B: Subjects who start on treatment with olaparib tablets, according to the drug label and physician’s discretion."}
• {"criterion_text":"- Part B: 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)."}
• {"criterion_text":"- Part B: Expected to be on olaparib treatment for ≥ 3 months."}
• {"criterion_text":"- Part B: Eastern Cooperative Oncology Group (ECOG) performance status of 0-3."}

Exclusion criteria

• {"criterion_text":"- Part A+B: Concurrent use of other anti-cancer therapies."}
• {"criterion_text":"- Part A+B: Concurrent use of potent inducers or inhibitors of CYP3A4 as assessed with the KNMP “G-standaard”."}
• {"criterion_text":"- Part A+B: Known contra-indications for treatment with cobicistat in line with the summary of product characteristics."}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"AUC0-12h determined using noncompartmental analysis; multiple PK samples collected after one week of each treatment regimen at times: pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8 hours (and if possible 10 and 12 hours) after olaparib intake."}
• {"endpoint_text":"- Part B: The number of patients who require a dose reduction due to toxicity will be registered.","definition_or_measurement_approach":"Counting/registration of patients who require dose reduction due to toxicity during treatment."}

Netherlands

Earliest CTIS Part Ii Submission Date

30-09-2024

Latest Decision Or Authorization Date

24-07-2025

Processing Time Days

297

Number Of Sites

14

Number Of Participants

82

Primary sponsor

Full Name

Stichting Radboud universitair medisch centrum

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands