Carcinoma, HepatocellularPhase 1NCT00370513
A Phase I Study of Pazopanib in Adult Patients With Liver Cancer
A Phase 1 study testing pazopanib in people with Carcinoma, Hepatocellular, run by GlaxoSmithKline at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- pazopanib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 6 Dec 2006to 8 Apr 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- High blood pressure
- Have had a blood clot during the past 6 months
- History of bleeding blood vessels
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United States1 site
GSK Investigational Site
San Francisco, California, 94115
About this study
Official title: A Phase I, Open-Label, Dose-Escalation, Multi-Center Study or Pazopanib (GW786034) in Adult Patients With Hepatocellular Cancer
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
- Being tested
- pazopanib
- Keywords
- pazopanib, liver cancer, hepatocellular cancer
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pazopanibDrug
Pazopanib is a potent, multi-target receptor tyrosine kinase inhibitor of VEGFR.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: pazopanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: throughout the study
Secondary outcomes (1)
Various pharmacokinetic parametersAlpha-fetoprotein (AFP) measurements and scans
Measured: throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2006 (estimated)
- Study start6 Dec 2006
- Primary completion8 Apr 2009
- Study completion8 Apr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00370513
- Sponsor's protocol ID
- VEG107200
- Status last verified
- Nov 2017
- First submitted
- 29 Aug 2006
- Last updated
- 17 Nov 2017
- Results posted
- No
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 Nov 1;17(21):6914-23. doi: 10.1158/1078-0432.CCR-11-0793. Epub 2011 Aug 10.
PubMed 21831954
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Dose-Escalation, Multi-Center Study or Pazopanib (GW786034) in Adult Patients With Hepatocellular Cancer
- ClinicalTrials.gov ID
- NCT00370513
- Acronym / sponsor ID
- VEG107200
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- pazopanib, liver cancer, hepatocellular cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2006 (actual)
- Primary completion
- 8 Apr 2009 (actual)
- Study completion
- 8 Apr 2009 (actual)
- First posted
- 31 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pazopanib Arm | Experimental | Drug: pazopanibDifferent 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pazopanibPazopanib is a potent, multi-target receptor tyrosine kinase inhibitor of VEGFR. | Drug | Pazopanib Arm |
Primary outcome
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).
Time frame: throughout the study
1 secondary outcome
Various pharmacokinetic parametersAlpha-fetoprotein (AFP) measurements and scans
Time frame: throughout the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Background: PubMed 21831954Yau 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.
- Results for study VEG107200 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing pazopanib in people with Carcinoma, Hepatocellular, run by GlaxoSmithKline at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Hong Kong, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: throughout the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00370513, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.