Study With Improved Solubility Pazopanib

Netherlands Cancer Institute (NKI)

Status and phase: Completed; Early Phase 1

Conditions: Pharmacokinetics of Pazopanib

Treatments: Drug: New Pazopanib formulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02810756

N16PZN

Details and patient eligibility

About

The pharmacokinetics of a new formulation with Pazopanib will be studied. This will be done in a patient cohort of n = 12.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Treated patients

Experimental group

Treatment:

Drug: New Pazopanib formulation