Study With Improved Solubility Pazopanib
Early Phase 1
Completed
- Conditions
- Pharmacokinetics of Pazopanib
- Interventions
- Registration Number
- NCT02810756
- Lead Sponsor
- The Netherlands Cancer Institute
- Brief Summary
The pharmacokinetics of a new formulation with Pazopanib will be studied. This will be done in a patient cohort of n = 12.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treated patients New Pazopanib formulation -
- Primary Outcome Measures
Name Time Method Plasma concentration 24 hours Concentration of pazopanib in plasma
- Secondary Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (1)
Netherlands Cancer Institute
🇳🇱Amsterdam, North Holland, Netherlands