Improving the tolerability of the oral targeted anti-cancer drug pazopanib by food intake (DIET).

Completed

• Conditions: renal cell carcinoma; 10038364

• Registration Number: NL-OMON47219
• Lead Sponsor: Apotheek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2018-08-09
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 97

Inclusion Criteria

1) Subjects must provide written informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow-up.
2) * 18 year old men and women who use pazopanib
3) Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

Exclusion Criteria

1) Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including,
2) Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject*s safety, provision of informed consent, or compliance to study procedures.
3) Unable or unwilling to discontinue use of prohibited medications
4) Concurrent use of other substances known or likely to interfere with the pharmacokinetics of pazopanib.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>Part A<br /><br>The aim of this part of the study is to determine the equivalent reduced dose<br /><br>of pazopanib when taken with a continental breakfast compared to the registered<br /><br>intake of pazopanib (e.g. 800 mg OD without food)<br /><br><br /><br>Part B<br /><br>The aim of this part of the study is to show a decrease of the side effects,<br /><br>diarrhea and nausea when an pazopanib is taken with food. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Part A<br /><br>To explore, quantify and describe the correlation in the occurrence of side<br /><br>effects when pazopanib is taken with food.<br /><br><br /><br>Part B<br /><br>To explore, quantify and describe patients preference; pazopanib intake with or<br /><br>without food.<br /><br>To explore the progression free survival of the total cohort of the patients<br /><br>and to compare this against historical data. </p><br>