A Phase I Study of Pazopanib in Adult Patients With Liver Cancer

November 13, 2017 updated by: GlaxoSmithKline

A Phase I, Open-Label, Dose-Escalation, Multi-Center Study or Pazopanib (GW786034) in Adult Patients With Hepatocellular Cancer

Liver cancer is a good target for anti-angiogenic treatments such as pazopanib. The effect of pazopanib in patients with liver cancer are unknown. This study is designed to evaluate the safety, tolerability and best dose of pazopanib to be given to patient with liver cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • GSK Investigational Site
  • Taiwan
      • Taipei, Taiwan, 100
        • GSK Investigational Site
  • United States
    • California
      • San Francisco, California, United States, 94115
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Diagnosis of advanced liver cancer adequate bone marrow, liver and kidney function
  • Any local therapy for tumor must have been completed at least 4 weeks prior to enrolling in study

Exclusion criteria:

  • Pregnant or breastfeeding
  • Any serious or unstable medical or psychiatric conditions
  • History of metastases to central nervous system
  • History of ulcer, inflammatory bowel disease or disease of the gut
  • History of HIV, or uncontrolled infection
  • Have had a cardiac condition or stoke during the past 6 months
  • High blood pressure
  • Have had a blood clot during the past 6 months
  • History of bleeding blood vessels

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pazopanib Arm
Different doses of oral pazopanib once daily for the duration of the study starting on Day 1 of Treatment Period 1. Treatment continues until disease progression or withdrawl from study.
Drug: pazopanib
Pazopanib is a potent, multi-target receptor tyrosine kinase inhibitor of VEGFR.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events (AEs) and changes in vital signs and laboratory values. A dose regimen where no more than 1 out of 6 subjects experience a dose-limiting toxicity (DLT) will define the maximum tolerated dose (MTD).
Time Frame: throughout the study
throughout the study

Secondary Outcome Measures

Outcome Measure
Time Frame
Various pharmacokinetic parametersAlpha-fetoprotein (AFP) measurements and scans
Time Frame: throughout the study
throughout the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2006

Primary Completion (Actual)

April 8, 2009

Study Completion (Actual)

April 8, 2009

Study Registration Dates

First Submitted

August 29, 2006

First Submitted That Met QC Criteria

August 29, 2006

First Posted (Estimate)

August 31, 2006

Study Record Updates

Last Update Posted (Actual)

November 17, 2017

Last Update Submitted That Met QC Criteria

November 13, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VEG107200

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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