Hepatocellular CarcinomaPhase 2NCT01273662
Axitinib as Second-line Treatment for Advanced Hepatocellular Carcinoma
A Phase 2 study testing AG-013736 in people with Hepatocellular Carcinoma, run by National Taiwan University Hospital at 3 sites in Taiwan.
Trial summary
This is a phase II study of axitinib as the second-line on the treatment of advanced hepatocellular carcinoma (HCC). The purpose of this study is a proof-of-concept study to see if axitinib has any anti-tumor effect in HCC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- AG-013736
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 3 sitesTaiwan
- Study dates
- Apr 2011to Dec 2016
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically diagnosed HCC, OR clinically diagnosed HCC
- Inoperable tumor(s) and no applicable curative therapy. Not amenable to loco-regional therapy
- Documented progression with or intolerance to sorafenib treatment as first- line therapy for advanced HCC
- At least one measurable tumor, according to RECIST version 1.1, that has not been treated with any local procedure
- ECOG performance status 0 or 1
- Life expectancy is at least 2 months
- Child-Pugh class A liver function.
Who cannot join
- Systemic therapy other than sorafenib as first-line therapy for advanced HCC
- History of HCC tumor rupture
- Presence of brain or leptomeningeal metastases
- Esophageal/gastric varices or active peptic ulcers that are considered to have high risk of bleeding
- History of upper gastrointestinal bleeding within 1 year
- Major systemic diseases that the investigator considers inappropriate for participation
Show all 12Show fewer
- Uncontrollable hypertension
- Proteinuria
- Current use or anticipated need for treatment with potent CYP3A4 inhibitor, CYP3A4 or CYP1A2 inducers
- Requirement of anticoagulant therapy with oral vitamin K antagonists
- Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol
- Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation and in the judgment of the investigator would make the patient inappropriate for entry into this study
Trial locations and contacts
3 sites in 1 country.
Taiwan3 sites
National Taiwan University Hospital
Taipei, 100
Taipei Veterans General Hospital
Taipei, 11217
Tri-Service General Hospital
Taipei, 114
About this study
This is a phase II study of axitinib as the second-line on the treatment of advanced hepatocellular carcinoma (HCC).
The purpose of this study is a proof-of-concept study to see if axitinib has any anti-tumor effect in HCC. The primary endpoint is disease stabilization that lasts for at least 8 weeks without progression of tumor-related symptoms.
Read the detailed description
Axitinib can can inhibit the activity of multiple angiogenesis-related signaling pathways. Promising anti-tumor activity has been demonstrated in patients with renal cell carcinoma, thyroid cancer, and melanoma. The potent anti-angiogenic activity of axitinib makes it a promising agent for the treatment of HCC.
This is a single-arm, open-label phase II trial. Eligible patients will receive axitinib, starting at 5 mg orally twice daily in the fasting status, until objective disease progression, development of unacceptable toxicity, or voluntary discontinuation. Dose titration will be done according to the severity of adverse events.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- AG-013736
- Keywords
- HCC
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AG-013736Drug
Also called Axitinib
All enrolled patients will receive axitinib, 5 mg orally twice daily with food, until objective disease progression, development of unacceptable toxicity, or voluntary discontinuation by the subjects.
| Study group | Role | What they receive |
|---|---|---|
| Axitinib | Experimental | Not described Receives: Drug: AG-013736 |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease stabilization
Measured: 8 weeks until tumor progression
Secondary outcomes (1)
time-to-tumor progression
Measured: 8 weeks until tumor progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2011 (estimated)
- Study startApr 2011
- Primary completionMar 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tri-Service General Hospital (TSGH), Taipei Veterans General Hospital, Taiwan
- Responsible party
- Sponsor
- Investigators
- Ann-Lii Cheng, MD, PhD, Principal investigator, Director/Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01273662
- Sponsor's protocol ID
- 201008013M
- Status last verified
- Feb 2017
- First submitted
- 6 Jan 2011
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Axitinib as Second-line Treatment for Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01273662
- Acronym / sponsor ID
- 201008013M
- Conditions
- Hepatocellular Carcinoma
- Keywords
- HCC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Tri-Service General Hospital (TSGH), Taipei Veterans General Hospital, Taiwan
- Study start
- Apr 2011 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 10 Jan 2011 (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.
This is a phase II study of axitinib as the second-line on the treatment of advanced hepatocellular carcinoma (HCC).
The purpose of this study is a proof-of-concept study to see if axitinib has any anti-tumor effect in HCC. The primary endpoint is disease stabilization that lasts for at least 8 weeks without progression of tumor-related symptoms.
Detailed description
Axitinib can can inhibit the activity of multiple angiogenesis-related signaling pathways. Promising anti-tumor activity has been demonstrated in patients with renal cell carcinoma, thyroid cancer, and melanoma. The potent anti-angiogenic activity of axitinib makes it a promising agent for the treatment of HCC.
This is a single-arm, open-label phase II trial. Eligible patients will receive axitinib, starting at 5 mg orally twice daily in the fasting status, until objective disease progression, development of unacceptable toxicity, or voluntary discontinuation. Dose titration will be done according to the severity of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Axitinib | Experimental | Drug: AG-013736 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically diagnosed HCC, OR clinically diagnosed HCC
- Inoperable tumor(s) and no applicable curative therapy. Not amenable to loco-regional therapy
- Documented progression with or intolerance to sorafenib treatment as first- line therapy for advanced HCC
- At least one measurable tumor, according to RECIST version 1.1, that has not been treated with any local procedure
- ECOG performance status 0 or 1
Key exclusion criteria (12 listed)
- Systemic therapy other than sorafenib as first-line therapy for advanced HCC
- History of HCC tumor rupture
- Presence of brain or leptomeningeal metastases
- Esophageal/gastric varices or active peptic ulcers that are considered to have high risk of bleeding
- History of upper gastrointestinal bleeding within 1 year
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 |
|---|---|---|
| AG-013736Also: AxitinibAll enrolled patients will receive axitinib, 5 mg orally twice daily with food, until objective disease progression, development of unacceptable toxicity, or voluntary discontinuation by the subjects. | Drug | Axitinib |
Primary outcome
disease stabilization
Time frame: 8 weeks until tumor progression
1 secondary outcome
time-to-tumor progression
Time frame: 8 weeks until tumor progression
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 9 Feb 2017.
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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.
Ann-Lii Cheng, MD, PhD principal investigator
Director/Professor
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AG-013736 in people with Hepatocellular Carcinoma, run by National Taiwan University Hospital at 3 sites in Taiwan.
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 7 inclusion and 12 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 9 Feb 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
disease stabilization (time frame: 8 weeks until tumor progression). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2017.