Effect of dosing time on the pharmacokinetics and pharmacodynamics of sunitinib
Recruiting
- Conditions
- Patients with advanced clear cell renal cell carcinoma, metastatic GIST or advanced p-NET treated with sunitinib
- Registration Number
- NL-OMON20106
- Lead Sponsor
- Erasmus Medical Center, Department of Medical Oncology
- Brief Summary
Kloth et al. Relationship Between Sunitinib Pharmacokinetics and Administration Time: Preclinical and Clinical Evidence. Clin Pharmacokinet. 2015;54(8):851-8
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 18
Inclusion Criteria
1. Age ¡Ý 18 years;
2. Histological or cytological confirmed diagnosis of advanced clear©\cell renal cell
carcinoma, GIST or pancreatic neuro©\endocrine tumor, treated with sunitinib;
Exclusion Criteria
1. Pregnant or child nursing patients;
2. Serious illness or medical unstable condition requiring treatment, symptomatic CNS
metastasis or history of psychiatric disorder that would prohibit the understanding
and giving of informed consent;
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference in pharmacokinetics of sunitinib in morning intake compared to evening intake.
- Secondary Outcome Measures
Name Time Method 1. To investigate whether daily variation in CYP3A4 activity exists in humans based<br>on midazolam and 4©\hydroxycholesterol pharmacokinetics and urine 4©\OHcholesterol;<br /><br>2. To investigate if evening dosing of sunitinib affects the side effects of this drug;<br /><br>3. To investigate the influence of single©\nucleotide polymorphisms in PK genes on<br>the exposure to sunitinib (based on the MEC02.1002 protocol).