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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
Not Enrolling
Both
Carcinoma, Hepatic Cell, Liver Cancer

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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 SiteBakersfield, California  93309