Absolute bioavailability trial of oral imatinib (Glivec®) using a stable isotope labeled intravenous imatinib microdose.

Completed

• Conditions: cancer; 10027655

• Registration Number: NL-OMON46280
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-09-05
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 7

Inclusion Criteria

1. Locally advanced or metastatic cancer;
2. On imatinib treatment at a stable dose of 400 mg once daily in the morning for at least 7 days (steady state plasma concentration)
3. Age >= 18 years;
4. Able and willing to give written informed consent;
5. WHO performance status of 0, 1 or 2;
6. Able and willing to undergo blood sampling for PK analysis;

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, ketoconazol, ritonavir and voriconazol), inhibitors of Pgp (e.g. ciclosporine, kinidine and verapamil), inhibitors of BCRP (e.g. lapatinib), inductors of CYP3A4, Pgp or BCRP;
3. Woman who are pregnant or breast feeding;
4. Patients suffering from any known disease or dysfunction that might influence the dissolution and/or absorption of imatinib (e.g. inflammatory bowel disease).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine the absolute bioavailability of imatinib (Glivec®) at steady state<br /><br>after concomitant administration of a single 100 µg microdose of imatinib-d8</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>N/A</p><br>