The food-effect of a standardized Dutch breakfast on the pharmacokinetics of oral alectinib (Alecensa®) using a stable isotopically labelled microtracer approach

Recruiting

• Conditions: cancer; solid tumors; 10027655

• Registration Number: NL-OMON56401
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

1. Currently treated with alectinib for an oncological indication;
2. On alectinib treatment at a stable dose of 600 mg twice daily according to
standard of care;

Exclusion Criteria

1. Any treatment with investigational drugs within 30 days or 5 half-lives
prior to receiving the investigational treatment;
2. Any treatment with inhibitors of CYP3A4 (e.g. boceprevir, claritromycine,
erytromycine, indinavir, itraconazol, ketoconazole, ritonavir and voriconazol),
or inductors of CYP3A4 within two weeks or 5 half-lives prior to the start of
the study. Alectinib is not a substrate for P-gp, BCRP, OATP1B1 or OATP1B3 [15].
3. Patients suffering from any known disease or dysfunction that might
influence the dissolution and/or absorption of alectinib (e.g. inflammatory
bowel disease, gastric bypass).

Study & Design

• Study Type: Interventional
• Study Design: Not specified