Pharmacokinetics of Pazopanib
Conditions
Brief summary
The pharmacokinetics of a new formulation with Pazopanib will be studied. This will be done in a patient cohort of n = 12.
Interventions
DRUGNew Pazopanib formulation
Sponsors
The Netherlands Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Locally advanced or metastatic cancer; * Able and willing to give written consent; * WHO performance status of 0, 1 or 2; * Able and willing to undergo blood sampling for PK analysis; * Minimal acceptable safety laboratory values; * Negative pregnancy test for female patients with childbearing potential; * Able and willing to swallow oral medication.
Exclusion criteria
* Any treatment with investigational drugs within 30 days prior to receiving the investigational treatment; * Any treatment with CYP3A4, BCRP or PGP interfering drugs; * Patients who received treatment with Votrient(R) kess than 1 week ago; * Woman who are pregnant or breast feeding; * Patients suffering from any known condition that may influence the dissolution or absorption of Pazopanib.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentration | 24 hours | Concentration of pazopanib in plasma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 1 week | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |
| Area under the plasma concentration versus time curve (AUC) | 24 hours | Area under the plasma concentration versus time curve (AUC) |
Countries
Netherlands
Outcome results
None listed