Hepatocellular CarcinomaPhase 2AXITINIBNCT01334112
Study of Axitinib in Patients With Unresectable Hepatocellular Carcinoma
A Phase 2 study testing Axitinib (AG-013736) in people with Hepatocellular Carcinoma, run by University Health Network, Toronto at 2 sites in Canada.
Trial summary
The purpose of this study is to evaluate the potential role of Axitinib (AG-013736) in the treatment of unresectable/metastatic hepatocellular carcinoma (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?
- Axitinib (AG-013736)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesCanada
- Study dates
- Jan 2011to Mar 2018
- 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
- Unresectable and/or metastatic Hepatocellular Carcinoma
- Previous treatment with tyrosine kinase inhibitors or antiangiogenic drugs
- Life expectancy of ≥12 weeks
- At least one tumor lesion
- At least 2 weeks since the end of prior systemic treatment
- No evidence of pre-existing uncontrolled hypertension
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- ECOG 0 or 1
- Adequate organ function
- Not appropriate for curative therapy
- Child A or B7 cirrhosis
- CLIP score ≤ 4
Who cannot join
- Received any other systemic therapy for Hepatocellular Carcinoma within 2 weeks prior to treatment
- Major surgery <4 weeks or radiation therapy <2 weeks of starting the study treatment
- Previous or concurrent cancer that is distinct in primary site or histology from Hepatocellular Carcinoma
- Severe acute or chronic medical or psychiatric condition
- Need for treatment with prohibited drugs
- Has received local therapy to all measurable lesions
Show all 9Show fewer
- Stage B8 or higher liver cirrhosis
- Ascites refractory to diuretic therapy
- Clinically significant ECG abnormality
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Foothills Hospital, Alberta Health Services
Calgary, Alberta
University Health Network, Princess Margaret Hospital
Toronto, Ontario
About this study
Official title: A Phase II Trial of Axitinib (AG-013736) After Prior Antiangiogenic Therapy in Advanced Hepatocellular Carcinoma
The purpose of this study is to evaluate the potential role of Axitinib (AG-013736) in the treatment of unresectable/metastatic hepatocellular carcinoma (HCC)
Read the detailed description
This is a phase II study of an investigational drug, Axitinib following prior antiangiogenic therapy in patients with advanced hepatocellular carcinoma. Hepatocellular carcinoma (HCC) is a primary cancer of the liver. Angiogenesis is a physiological process involving the growth of new blood vessels from pre-existing vessels. A tyrosine kinase is an enzyme that can inhibit angiogenesis. In this study, patients with advanced HCC who have failed prior antiangiogenic therapy, will receive Axitinib in cycles of 4 weeks. Axitinib is an oral, potent and selective inhibitor of angiogenesis. This study will evaluate the response rate of HCC following treatment with Axitinib as well as safety, feasibility, overall survival of patients, progression-free survival, and quality of life in persons with unresectable HCC. The study also compares response determined by RECIST to response determined by Choi Criteria.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Axitinib (AG-013736)
- Keywords
- Hepatocellular Carcinoma, Advanced Hepatocellular Carcinoma, Liver Cancer, Axitinib, AG-013736
- 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.
Axitinib (AG-013736)Drug
5mg, oral, twice daily, continuous dosing. A dosing cycle is defined as 4 weeks. Treatment may continue until disease progression/relapse
| Study group | Role | What they receive |
|---|---|---|
| Axitinib | Experimental | Oral Axitinib (5mg, twice daily) will be administered to all patients Receives: Drug: Axitinib (AG-013736) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Measured: Response rate assessed by CT scan at 16 weeks
Secondary outcomes (7)
Feasibility
The ability to administer one or more cycles of Axitinib to >70% of patients at a dose of 5mg po BID
Measured: Assessed at the end of stage 1 (10 patients accrued) and at the end of trial (Stage 2, 29 patients total)
Overall survival
Measured: At the completion of trial, 1.5 years
Response rate comparison
Measured: Comparison of outcomes with RECIST criteria to Choi criteria and changes to perfusion on DCE ultrasound will occur at the end of stage 1 (after accrual of 10 patients) and trial completion
Progression-free survival
Measured: At trial completion, 1.5 years
Quality of life
Assessed by FACT-Hep
Measured: At completion of trial, 1.5 years
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Efficacy and Toxicity in Asian vs non-Asian patients will be assessed by comparing the adverse effects profile and rate of grade 3 and grade 4 toxicity in these populations
Measured: At completion of trial, 1.5 years
Number of Participants with Adverse Events as a Measure of Safety
Adverse effects profile and rate of grade 3 and 4 toxicity will be assessed as a measure of safety
Measured: At completion of trial, 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2011 (estimated)
- Study startJan 2011
- Primary completionMar 2018
- Study completionMar 2018
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 University Health Network, TorontoThe 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Jennifer Knox, MSc, FRCPC, MD, Principal investigator, University Health Network, Princess Margaret HospitalKelly Burak, MD, FRCPC, BSc, MSc, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01334112
- Sponsor's protocol ID
- WS515376
- Acronym
- AXITINIB
- Status last verified
- Dec 2019
- First submitted
- 14 Feb 2011
- Last updated
- 12 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Axitinib (AG-013736) After Prior Antiangiogenic Therapy in Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01334112
- Acronym / sponsor ID
- AXITINIB / WS515376
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Advanced Hepatocellular Carcinoma, Liver Cancer, Axitinib, AG-013736
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jan 2011
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 12 Apr 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.
The purpose of this study is to evaluate the potential role of Axitinib (AG-013736) in the treatment of unresectable/metastatic hepatocellular carcinoma (HCC)
Detailed description
This is a phase II study of an investigational drug, Axitinib following prior antiangiogenic therapy in patients with advanced hepatocellular carcinoma. Hepatocellular carcinoma (HCC) is a primary cancer of the liver. Angiogenesis is a physiological process involving the growth of new blood vessels from pre-existing vessels. A tyrosine kinase is an enzyme that can inhibit angiogenesis. In this study, patients with advanced HCC who have failed prior antiangiogenic therapy, will receive Axitinib in cycles of 4 weeks. Axitinib is an oral, potent and selective inhibitor of angiogenesis. This study will evaluate the response rate of HCC following treatment with Axitinib as well as safety, feasibility, overall survival of patients, progression-free survival, and quality of life in persons with unresectable HCC. The study also compares response determined by RECIST to response determined by Choi Criteria.
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: Axitinib (AG-013736)Oral Axitinib (5mg, twice daily) will be administered to all patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Unresectable and/or metastatic Hepatocellular Carcinoma
- Previous treatment with tyrosine kinase inhibitors or antiangiogenic drugs
- Life expectancy of ≥12 weeks
- At least one tumor lesion
- At least 2 weeks since the end of prior systemic treatment
Key exclusion criteria (9 listed)
- Received any other systemic therapy for Hepatocellular Carcinoma within 2 weeks prior to treatment
- Major surgery <4 weeks or radiation therapy <2 weeks of starting the study treatment
- Previous or concurrent cancer that is distinct in primary site or histology from Hepatocellular Carcinoma
- Severe acute or chronic medical or psychiatric condition
- Need for treatment with prohibited drugs
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 |
|---|---|---|
| Axitinib (AG-013736)5mg, oral, twice daily, continuous dosing. A dosing cycle is defined as 4 weeks. Treatment may continue until disease progression/relapse | Drug | Axitinib |
Primary outcome
Response rate
Time frame: Response rate assessed by CT scan at 16 weeks
7 secondary outcomes
Feasibility
Time frame: Assessed at the end of stage 1 (10 patients accrued) and at the end of trial (Stage 2, 29 patients total)
Overall survival
Time frame: At the completion of trial, 1.5 years
Response rate comparison
Time frame: Comparison of outcomes with RECIST criteria to Choi criteria and changes to perfusion on DCE ultrasound will occur at the end of stage 1 (after accrual of 10 patients) and trial completion
Progression-free survival
Time frame: At trial completion, 1.5 years
Quality of life
Time frame: At completion of trial, 1.5 years
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: At completion of trial, 1.5 years
Number of Participants with Adverse Events as a Measure of Safety
Time frame: At completion of trial, 1.5 years
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 12 Dec 2019.
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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.
Jennifer Knox, MSc, FRCPC, MD principal investigator
University Health Network, Princess Margaret Hospital
Kelly Burak, MD, FRCPC, BSc, MSc principal investigator
University of Calgary
2 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 Axitinib (AG-013736) in people with Hepatocellular Carcinoma, run by University Health Network, Toronto at 2 sites in Canada.
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 11 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 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
Response rate (time frame: Response rate assessed by CT scan at 16 weeks). 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 12 Dec 2019.