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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00370513
First received: August 29, 2006
Last updated: March 15, 2012
Last verified: February 2011
  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
Carcinoma, Hepatic Cell
Liver Cancer
Drug: pazopanib
Phase 1

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
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;17(21):6914-23.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00370513     History of Changes
Other Study ID Numbers: VEG107200
Study First Received: August 29, 2006
Last Updated: March 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
liver cancer
pazopanib
hepatocellular cancer

Additional relevant MeSH terms:
Carcinoma
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on July 23, 2014