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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00370513
Other study ID # VEG107200
Secondary ID
Status Completed
Phase Phase 1
First received August 29, 2006
Last updated November 13, 2017
Start date December 6, 2006
Est. completion date April 8, 2009

Study information

Verified date November 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date April 8, 2009
Est. primary completion date April 8, 2009
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Hong Kong GSK Investigational Site Hong Kong
Taiwan GSK Investigational Site Taipei
United States GSK Investigational Site San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Hong Kong,  Taiwan, 

References & Publications (1)

Yau T, Chen PJ, Chan P, Curtis CM, Murphy PS, Suttle AB, Gauvin J, Hodge JP, Dar MM, Poon RT. Phase I dose-finding study of pazopanib in hepatocellular carcinoma: evaluation of early efficacy, pharmacokinetics, and pharmacodynamics. Clin Cancer Res. 2011 Nov 1;17(21):6914-23. doi: 10.1158/1078-0432.CCR-11-0793. Epub 2011 Aug 10. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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). throughout the study
Secondary Various pharmacokinetic parametersAlpha-fetoprotein (AFP) measurements and scans throughout the study
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