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

NCT00370513 | Completed Phase 1

• 1 other identifier: VEG107200
• Study Type: interventional
• Target: 28
• Locations: 3 countries
• Sites: 3

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.

Conditions

Carcinoma, Hepatocellular

Keywords

pazopanib; liver cancer; hepatocellular cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Various pharmacokinetic parametersAlpha-fetoprotein (AFP) measurements and scans

  throughout the study

Study Arms (1)

Pazopanib Arm

EXPERIMENTAL

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.

Drug: pazopanib

Interventions

pazopanib DRUG

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

Pazopanib Arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

San Francisco, California, 94115, United States

Location

GSK Investigational Site

Hong Kong, Hong Kong

Location

GSK Investigational Site

Taipei, 100, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 21831954 BACKGROUND

Related Links

• Results for study VEG107200 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Interventions

pazopanib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2006
• First Posted: August 31, 2006
• Study Start: December 6, 2006
• Primary Completion: April 8, 2009
• Study Completion: April 8, 2009
• Last Updated: November 17, 2017

Record last verified: 2017-11

Locations

TW (1); US (1); HK (1)