Last updated: 11/04/2018 13:27:38
A Phase I Study of Pazopanib in Adult Patients with Liver Cancer
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Phase I, Open-Label, Dose-Escalation, Multi-Center Study or Pazopanib (GW786034) in Adult Patients with Hepatocellular Cancer
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
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).
Timeframe: throughout the study
Secondary outcomes:
Various pharmacokinetic parametersAlpha-fetoprotein (AFP) measurements and scans
Timeframe: throughout the study
Interventions:
Drug: pazopanib
Enrollment:
28
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
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;17(21):6914-23.
Medical condition
Carcinoma, Hepatocellular
Product
pazopanib
Collaborators
Not applicable
Study date(s)
December 2006 to April 2009
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
21+ years
Accepts healthy volunteers
No
- Diagnosis of advanced liver cancer
- adequate bone marrow, liver and kidney function
- Pregnant or breastfeeding
- Any serious or unstable medical or psychiatric conditions
Inclusion and exclusion 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
Trial location(s)
Location
GSK Investigational Site
San Francisco, California, United States, 94115
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2009-08-04
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study VEG107200 can be found on the GSK Clinical Study Register.
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