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

Carcinoma, Hepatocellular Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00370513
• Other study ID #: VEG107200
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Neoplasms

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

External Links

•   Results for study VEG107200 can be found on the GSK Clinical Study Register.