se of individual PK-guided sunitinib dosing: A feasibility study in patients with advanced solid tumors

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

1. Patients with histopathologically confirmed advanced or metastatic solid tumors for whom sunitinib is standard therapy, of for whom no standard therapy is available;2. Age >= 18 years;;3. Able and willing to give written informed consent;;4. Able and willing to undergo blood sampling for pharmacogenetic and pharmacokinetic analysis;;5. Able to swallow oral medications;6. Life expectancy >= 3 months, allowing adequate follow up of toxicity evaluation and antitumor activity;;7. WHO performance status of 0 or 1;;8. Evaluable disease according to RECIST 1.1 criteria;;9. Minimal acceptable safety laboratory values
• ANC of >= 1.5 x 109 /L
• Platelet count of >= 100 x 109 /L
• Hepatic function as defined by serum bilirubin <= 1.5 x ULN, ASAT and ALAT <=
• 2.5 x ULN
• Renal function as defined by serum creatinine <= 1.5 x ULN or creatinine clearance >= 50 mL/min (by Cockcroft-Gault formula);;10. No radio- or chemotherapy or other investigational drug treatment within the last 4 weeks prior to study entry, with the exception of palliative radiotherapy (8Gy, or in the extremities).

Exclusion Criteria

1. Current treatment in another therapeutic clinical trial;2. Congestive heart failure, myocardial infarction or coronary artery bypass graft in the previous six months, ongoing severe or unstable angina or any unstable arrhythmia requiring medication;3. Patients with known alcoholism, drug addiction and/or psychotic disorders in the history that are not suitable for adequate follow up;4. Women who are pregnant or breast feeding.;5. Both men and women enrolled in this trial must agree to use a reliable contraceptive method throughout the study (definition of adequate contraceptive methods will be based on the judgment of the principal investigator or a designated associate). ;6. Legal incapacity.;7. Known allergy/intolerance to sunitinib or any of the excipients.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Tumor response (RECIST): ORR, PR, TTP, PFS<br /><br>Toxicity (CTC v4.2)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Pharmacokinetics (dried blood spots): total trough levels<br /><br>Pharmacogenetics: polymorfism of genes involved in pharmacokinetic and<br /><br>pharmacodynamic pathways.</p><br>