Study of high-dose sunitinib in patients with solid tumors.
- Conditions
- Adult patients with locally advanced or metastatic solid tumors for which no standard therapy exists.
- Registration Number
- NL-OMON20988
- Lead Sponsor
- VU Medical CenterAmsterdam
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
1. Signed (by the patient or legally acceptable representative) and dated Informed Consent Form
2. Histological or cytological documentation of incurable locally advanced or metastatic solid malignancy for which no standard therapy exists.
1. Evidence of a significant uncontrolled concomitant disease, such as cardiovascular disease (including stroke, New York Heart Association Class III or IV cardiac disease or myocardial infarction within 6 months prior to screening, unstable arrhythmia, clinically significant valvular heart disease and unstable angina); nervous system, pulmonary (including obstructive pulmonary disease and history of symptomatic bronchospasm), renal, hepatic, endocrine, or gastrointestinal disorders; or a serious non-healing wound or fracture.
2. Poorly controlled hypertension despite adequate blood pressure medication. Blood pressure must be ≤160/95 mmHg at the time of screening on a stable antihypertensive regimen. Blood pressure must be stable on at least 2 separate measurements.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the maximum tolerated dose (MTD) of sunitinib when administered once a week or once every two weeks.<br /><br>- To assess the safety and tolerability of sunitinib in a once weekly or once every two weeks dose schedule<br />
- Secondary Outcome Measures
Name Time Method - To determine the pharmacokinetic (PK) behaviour of the parent compound sunitinib and the primary, active, metabolite SU12662.<br /><br>- Preliminary assessment of the efficacy of sunitinib intermittent treatment, administered at the MTD determined for each of the time schedules of the study (once weekly or once every two weeks).<br /><br>- To determine a recommended phase II dose (RP2D) and the optimal dose schedule<br /><br>- To determine the skin and intratumoral concentration of sunitinib and their correlation with the plasma concentration.<br /><br>- To assess immune/angiogenesis modulating systemic and local effects such as MDSC, Tregs and DC subset frequencies and tumor infiltrating leukocytes