Skip to main content
OpenTrials
Completed

NCT Number: NCT02810756

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pharmacokinetics of Pazopanib

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Netherlands Cancer Institute

Amsterdam, North Holland, 1066 CX, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

New Pazopanib formulation

Drug

Primary outcomes

  1. Plasma concentration

    Time frame: 24 hours

    Concentration of pazopanib in plasma

Secondary outcomes

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: 1 week

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  2. Area under the plasma concentration versus time curve (AUC)

    Time frame: 24 hours

    Area under the plasma concentration versus time curve (AUC)

Sponsors and collaborators

Lead sponsor

The Netherlands Cancer Institute

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 23, 2016
Registry last updated
Sep 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.