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

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: August 29, 2006
Last updated: March 15, 2012
Last verified: February 2011
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.

Condition Intervention Phase
Carcinoma, Hepatic Cell Liver Cancer Drug: pazopanib Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label, Dose-Escalation, Multi-Center Study or Pazopanib (GW786034)in Adult Patients With Hepatocellular Cancer

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Various pharmacokinetic parametersAlpha-fetoprotein (AFP) measurements and scans [ Time Frame: throughout the study ]

Enrollment: 28
Study Start Date: December 2006
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00370513

United States, California
GSK Investigational Site
San Francisco, California, United States, 94115
Hong Kong
GSK Investigational Site
Hong Kong, Hong Kong
GSK Investigational Site
Taipei, Taiwan, 100
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT00370513     History of Changes
Other Study ID Numbers: VEG107200
Study First Received: August 29, 2006
Last Updated: March 15, 2012

Keywords provided by GlaxoSmithKline:
liver cancer
hepatocellular cancer

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases processed this record on July 21, 2017