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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00370513
Recruitment Status : Completed
First Posted : August 31, 2006
Last Update Posted : November 17, 2017
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Drug: pazopanib Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : December 6, 2006
Actual Primary Completion Date : April 8, 2009
Actual Study Completion Date : April 8, 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer
Drug Information available for: Pazopanib

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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00370513

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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
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Study Director: GSK Clinical Trials GlaxoSmithKline
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Responsible Party: GlaxoSmithKline Identifier: NCT00370513    
Other Study ID Numbers: VEG107200
First Posted: August 31, 2006    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Keywords provided by GlaxoSmithKline:
liver cancer
hepatocellular cancer
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases