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

NCT ID: NCT00370513

Last Updated: 2017-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-06

Study Completion Date

2009-04-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Carcinoma, Hepatocellular

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

pazopanib liver cancer hepatocellular cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pazopanib Arm

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.

Group Type EXPERIMENTAL

pazopanib

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

pazopanib

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GSK Investigational Site

San Francisco, California, United States

Site Status

GSK Investigational Site

Hong Kong, , Hong Kong

Site Status

GSK Investigational Site

Taipei, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Hong Kong Taiwan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 21831954 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

VEG107200

Identifier Type: -

Identifier Source: org_study_id