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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Carcinoma, Hepatocellular

Treatments: Drug: pazopanib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00370513

VEG107200

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Pazopanib Arm

Experimental group

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.

Treatment:

Drug: pazopanib