An Open-label Single-arm Pharmacokinetic Trial, Investigating the Effect of CYP3A4 inhibitor Ritonavir on the Pharmacokinetics of Erlotinib

Completed

Conditions: lung cancer
ono-small cell lung cancer
10038666

Registration Number: NL-OMON49212

Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 19

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>the effect of the highly potent CYP3A4 inhibitor ritonavir on the<br /><br>pharmacokinetics (PK) of erlotinib, measured as AUC0-24h, Cmax and Cmin.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. The incidence and severity of adverse events of co-administration of the<br /><br>highly potent CYP3A4 inhibitor ritonavir, according to CTC-AE v4.03.<br /><br>2. To determine the correlation between the ritonavir pharmacokinetics<br /><br>(AUC0-24h, Cmax and Cmin) and the incidence and severity of adverse events.<br /><br>3. To Study the effect of the highly potent CYP3A4 inhibitor ritonavir on the<br /><br>pharmacokinetics (PK) of the active metabolite of erlotinib OSI-420 , measured<br /><br>as AUC0-24h, Cmax and Cmin.<br /><br>4. Quantification of ctDNA, determined with Droplet digital PCR (ddPCR) </p><br>