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

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00370513
• Collaborator: (none)
• Enrollment: 28
• Locations: 3
• Arm: 1
• Actual Duration (Months): 28.1
• Patients Per Site: 9.3
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Hepatocellular	Drug: pazopanib	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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
• Actual Study Start Date: Dec 6, 2006
• Actual Primary Completion Date: Apr 8, 2009
• Actual Study Completion Date: Apr 8, 2009

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Various pharmacokinetic parametersAlpha-fetoprotein (AFP) measurements and scans [throughout the study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	San Francisco	California	United States	94115
2	GSK Investigational Site	Hong Kong		Hong Kong
3	GSK Investigational Site	Taipei		Taiwan	100

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

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 Nov 1;17(21):6914-23. doi: 10.1158/1078-0432.CCR-11-0793. Epub 2011 Aug 10.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00370513
• Other Study ID Numbers: VEG107200
• First Posted: Aug 31, 2006
• Last Update Posted: Nov 17, 2017
• Last Verified: Nov 1, 2017

• Keywords provided by GlaxoSmithKline: pazopanib; liver cancer; hepatocellular cancer
• Additional relevant MeSH terms: Carcinoma, Hepatocellular

Study Results

No Results Posted as of Nov 17, 2017