Investigation of the blood levels at a reduced dose of erlotinib with the addition of ritonavir compared to the normal dose of erlotinib

Phase 1

• Conditions: Advanced EGFR mutation positive non small cell lung cancer, pancreatic carcinoma, colorectal cancer and biliary cancer; MedDRA version: 21.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-004854-12-NL
• Lead Sponsor: Stichting Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-28
• Last Update Posted: 10 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Patients treated with single agent erlotinib 150mg QD, without disease progression at the first regular response evaluation after treatment initiation or patients who may benefit from erlotinib treatment
• Age = 18 years
• Accessible for repeated venipunctures
• Ability to understand the study and give signed informed consent prior to beginning of protocol specific procedures

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 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

•Concomitant use of medication(s) which could influence the pharmacokinetics of erlotinib within 14 days or five half-lives of the drug (whichever is shorter) before start of the study, consisting of (but not limited to) CYP3A4-inhibitors/inductors
•Active uncontrolled infection or severe cardiac dysfunction (such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina)
•Impaired hepatic function (total bilirubin > ULN or Child-Pugh A, B and C)
•Woman who are pregnant or breast feeding
•Progression on erlotinib at the latest regular response evaluation
•Current smokers or stopped smoking within 7 days before study allocation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified