Will pazopanib dose individualization result in less variability in pazopanib bloodconcentrations between individuals.

Conditions: Cancer,Solid tumorPhase I

Registration Number: NL-OMON22313

Lead Sponsor: eiden University Medical Center

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 13

Inclusion Criteria

1. Eligible patients for study entry include patients who have histologically or cytologically confirmed diagnoses of mRCC for which pazopanib is registered as the first line treatment OR Patients with a cytological/histological diagnosis of an advanced solid tumor for whom pazopanib may be a valuable treatment option as judged by the treating physician;

2. Patients must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow up. Procedures conducted as part of the subject’s routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol;

Exclusion Criteria

1. Current treatment in another therapeutic clinical trial;

2. History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 6 months prior to first dose of study drug;

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the effect of PK-guided individualized dosing of pazopanib on the interindividual variability in drug exposure.

Secondary Outcome Measures

Name	Time	Method
1. To determine the correlation between pazopanib trough and exposure levels;<br /><br>2. To determine the accuracy of the exposure levels (e.g. the deviation between the mean AUC at fixed dose and after dose adjustment) after the introduction of PK guided dosing;<br /><br>3. To determine the effect of pazopanib exposure on the systolic and diastolic blood pressure;<br /><br>4. To determine the effect of dose individualization on the frequency of the scored adverse events (CTCAE v4.0).