Renal Cell Cancer, GIST, pancreatic neuroendocrine tumor MedDRA version: 14.1 Level: LLT Classification code 10067518 Term: Pancreatic neuroendocrine tumor System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: LLT Classification code 10023400 Term: Kidney cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10055008 Te
Conditions
Interventions
Trade Name: Sutent
Product Name: Sunitinib
Product Code: EU/1/06/347/001-008
Pharmaceutical Form: Capsule
Trade Name: Dormicum
Product Name: Midazolam
Product Code: PL 29831/0140
Pharmaceutical Form
Sponsors
None listed
Eligibility
Sex/Gender
All
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 at study entry (see appendix A); 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 18 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
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 |
|---|---|
| Main Objective: To determine the influence of morning versus evening administration on the pharmacokinetics of sunitinib and its metabolite;Secondary Objective: To investigate whether daily variation in CYP3A4 activity exists in humans, based on midazolam and 4beta-hydroxycholesterol PK. To investigate if evening dosing of sunitinib affects the side effects of this drug. To investigate the influence of single-nucleotide polymorphisms in PK genes on the exposure to sunitinib (based on the MEC02.1002 protocol). ;Primary end point(s): -Determine differences in sunitinib pharmacokinetics during sunitinib administration in the morning compared to administration in the evening.;Timepoint(s) of evaluation of this end point: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Determine differences in adverse effects during sunitinib administration in the morning compared to administration in the evening.;Timepoint(s) of evaluation of this end point: 1 year | — |
Countries
Netherlands
Outcome results
None listed