A Phase I, Open-Label, Dose-Escalation, Multi-Center Study or Pazopanib (GW786034)in Adult Patients With Hepatocellular Cancer
Phase 1
21 Years
N/A
21 Years
N/A
Not Enrolling
Both
Carcinoma, Hepatic Cell, Liver Cancer
Both
Carcinoma, Hepatic Cell, Liver Cancer
Trial Information
A Phase I, Open-Label, Dose-Escalation, Multi-Center Study or Pazopanib (GW786034)in Adult Patients With Hepatocellular Cancer
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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).
Outcome Time Frame:
throughout the study
Principal Investigator
GSK Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
United States: Food and Drug Administration
Study ID:
VEG107200
NCT ID:
NCT00370513
Start Date:
December 2006
Completion Date:
April 2009
Related Keywords:
- Carcinoma, Hepatic Cell
- Liver Cancer
- liver cancer
- pazopanib
- hepatocellular cancer
- Carcinoma
- Liver Neoplasms
Name | Location |
|---|---|
| GSK Investigational Site | Bakersfield, California 93309 |
