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

This study is currently recruiting participants.

Verified by GlaxoSmithKline, October 2008

First Received: August 29, 2006 Last Updated: October 15, 2008 History of Changes

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00370513

Purpose

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
Liver Cancer	Drug: pazopanib	Phase I

MedlinePlus related topics: Cancer Liver Cancer

Drug Information available for: Pazopanib

U.S. FDA Resources

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

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 parameters Alpha-fetoprotein (AFP) measurements and scans [ Time Frame: throughout the study ]

Estimated Enrollment:	35
Study Start Date:	December 2006

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00370513

Contacts

Contact: US GSK Clinical Trials Call Center

877-379-3718

Locations

United States, California
GSK Investigational Site	Completed
San Francisco, California, United States, 94115
Hong Kong
GSK Investigational Site	Recruiting
Hong Kong, Hong Kong
Taiwan
GSK Investigational Site	Recruiting
Taipei, Taiwan, 100
GSK Investigational Site	Withdrawn
Taipei, Taiwan, 100

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	VEG107200
Study First Received:	August 29, 2006
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00370513 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

pazopanib
liver cancer
hepatocellular cancer

Study placed in the following topic categories:

Liver Neoplasms
Liver Diseases
Digestive System Diseases

Digestive System Neoplasms
Gastrointestinal Neoplasms
Hepatocellular Carcinoma

Additional relevant MeSH terms:

Liver Neoplasms
Liver Diseases
Neoplasms

Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009