Study With Improved Solubility Pazopanib

Proof of Principle and Pharmacological Phase 0 Study With Improved Solubility Pazopanib

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

Study Overview

• Status: Completed
• Conditions: Pharmacokinetics of Pazopanib
• Intervention / Treatment: Drug: New Pazopanib formulation

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • North Holland
    • Amsterdam, North Holland, Netherlands, 1066 CX
      • Netherlands Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treated patients	Drug: New Pazopanib formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma concentration	Concentration of pazopanib in plasma	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	1 week
Area under the plasma concentration versus time curve (AUC)	Area under the plasma concentration versus time curve (AUC)	24 hours

Collaborators and Investigators

• Sponsor: The Netherlands Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2016
• Primary Completion (Actual): August 28, 2017
• Study Completion (Actual): August 28, 2017

Study Registration Dates

• First Submitted: May 31, 2016
• First Submitted That Met QC Criteria: June 20, 2016
• First Posted (Estimate): June 23, 2016

Study Record Updates

• Last Update Posted (Actual): September 11, 2017
• Last Update Submitted That Met QC Criteria: September 8, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: N16PZN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will remain confidential