A Phase I Study of Pazopanib in Adult Patients With Liver Cancer - Full Text View

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Liver Cancer

Drug Information available for: Pazopanib

U.S. FDA Resources

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

Enrollment:	28
Study Start Date:	December 2006
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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. Other Name: pazopanib

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

Locations

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

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2011 Aug 10.

Responsible Party:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00370513 History of Changes
Other Study ID Numbers:	VEG107200
Study First Received:	August 29, 2006
Last Updated:	March 17, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

pazopanib
liver cancer
hepatocellular cancer

Additional relevant MeSH terms:

Liver Neoplasms
Carcinoma, Hepatocellular
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases

Liver Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on February 09, 2012