Effects of dosing time on the pharmacokinetics and pharmacodynamics of sunitinib.
- Conditions
- GIST, p-NETGISTp-NETrenal cell carcinoma10038364
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
Age >= 18 years;;Histological or cytological confirmed diagnosis of advanced clear-cell renal cell carcinoma, GIST or pancreatic neuro-endocrine tumor, treated with sunitinib;;WHO performance score <= 1 at study entry (see appendix A of the protocol);;Any stable dose of sunitinib at study entry, defined as no dose change within 3 weeks prior to pharmacokinetics; ;Adequate hematological functions (ANC > 1.0 x 109/L, platelets > 100 x 1012/L);;Adequate liver and renal function defined as bilirubin concentration <= 2 x ULN, AST and ALT <= 2.5 x ULN, serum creatinin concentration <= 2 x ULN;;Written informed consent;;For patients with reproductive potential a reliable method of contraception (excluding oral contraceptives) must be used
Pregnant or child nursing patients;;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;;Major surgery within 2 weeks prior to start of the protocol;;Use of CYP3A4 inhibiting or inducing medication as listed in appendix C;;Patients who are unable to collect blood from;;Patients with known allergy to sunitinib or midazolam;;Patients unwilling or unable to give written informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Pharmacokinetic values: AUC and clearance</p><br>
- Secondary Outcome Measures
Name Time Method <p>Toxicity (hypertension, fatigue, diarrhea, skin toxicity, mucositis, nausea,<br /><br>anorexia, any grade 3-4 toxicity).<br /><br>Difference in CYP3A4 activity in the morning and evening</p><br>