Influence of a fatty beverage (Milk) on the absorption of erlotinib: a randomized, cross-over pharmacokinetic study (MERLOT-study)

Phase 4

Completed

• Conditions: lung cancer; 10038666

• Registration Number: NL-OMON43280
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 28

Inclusion Criteria

1. Age * 18
2. Use of erlotinib monotherapy for at least 14 days (to guarantee steady-state) and willing to continue the treatment until the end of the study
3. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations

Exclusion Criteria

1. Age < 18 years
2. Pregnant or lactating patients
3. Impossibility to take oral drugs

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The difference in the bioavailabiliteit of erlotinib in patients taking a PPI<br /><br>or not , with or without milk.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Comparison of toxicity and side effects of erlotinib taken with water or milk .</p><br>