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NCT Number: NCT00370513

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

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Key information

Conditions

Carcinoma, Hepatocellular Adenocarcinoma Carcinoma Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site, Hong Kong

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Pazopanib

Drug

Pazopanib is a potent, multi-target receptor tyrosine kinase inhibitor of VEGFR.

Primary outcomes

  1. 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 outcomes

  1. Various pharmacokinetic parametersAlpha-fetoprotein (AFP) measurements and scans

    Time frame: throughout the study

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Aug 31, 2006
Registry last updated
Nov 17, 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.

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