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

A Phase I, Open-Label, Dose-Escalation, Multi-Center Study or Pazopanib (GW786034) in Adult Patients With Hepatocellular Cancer

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00370513
Enrollment
28
Registered
2006-08-31
Start date
2006-12-06
Completion date
2009-04-08
Last updated
2017-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Hepatocellular

Keywords

pazopanib, liver cancer, hepatocellular cancer

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.

Interventions

DRUGpazopanib

Pazopanib is a potent, multi-target receptor tyrosine kinase inhibitor of VEGFR.

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Various pharmacokinetic parametersAlpha-fetoprotein (AFP) measurements and scansthroughout the study

Countries

Hong Kong, Taiwan, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026