GIST, p-NET GIST p-NET renal cell carcinoma
Conditions
Interventions
Afternoon and evening intake of sunitinib in stead of morning intake of
sunitinib.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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 1.0 x 109/L, platelets > 100 x 1012/L);;Adequate liver and renal function defined as bilirubin concentration
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic values: AUC and clearance | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity (hypertension, fatigue, diarrhea, skin toxicity, mucositis, nausea, anorexia, any grade 3-4 toxicity). Difference in CYP3A4 activity in the morning and evening | — |
Countries
Netherlands
Outcome results
None listed