Study With Improved Solubility Pazopanib

Early Phase 1

Completed

• Conditions: Pharmacokinetics of Pazopanib
• Interventions: Drug: New Pazopanib formulation

• 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

Study Timeline

• Study First Submitted: 2016-05-31
• Study First Submitted QC: 2016-06-20
• Study First Posted: 2016-06-23
• Study Start: 2016-09-15
• Primary Completion: 2017-08-28
• Study Completion: 2017-08-28
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-08
• Last Update Posted: 2017-09-11

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