Back to resultsA Phase I Study of Pazopanib in Adult Patients With Liver Cancer
Primary Purpose
Carcinoma, Hepatocellular
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
pazopanib
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring pazopanib, liver cancer, hepatocellular cancer
Eligibility 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
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pazopanib Arm
Arm Description
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.
Outcomes
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).
Secondary Outcome Measures
Various pharmacokinetic parametersAlpha-fetoprotein (AFP) measurements and scans
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00370513
Brief Title
A Phase I Study of Pazopanib in Adult Patients With Liver Cancer
Official Title
A Phase I, Open-Label, Dose-Escalation, Multi-Center Study or Pazopanib (GW786034) in Adult Patients With Hepatocellular Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
December 6, 2006 (Actual)
Primary Completion Date
April 8, 2009 (Actual)
Study Completion Date
April 8, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular
Keywords
pazopanib, liver cancer, hepatocellular cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pazopanib Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
pazopanib
Intervention Description
Pazopanib is a potent, multi-target receptor tyrosine kinase inhibitor of VEGFR.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Various pharmacokinetic parametersAlpha-fetoprotein (AFP) measurements and scans
Time Frame
throughout the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
GSK Investigational Site
City
Hong Kong
Country
Hong Kong
Facility Name
GSK Investigational Site
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
21831954
Citation
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.
Results Reference
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A Phase I Study of Pazopanib in Adult Patients With Liver Cancer
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