Axitinib as Second-line Treatment for Advanced Hepatocellular Carcinoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Axitinib as Second-line Treatment for Advanced Hepatocellular Carcinoma

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: AG-013736


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Axitinib<br> | Drug: AG-013736<br>* 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.<br>* Other names: Axitinib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease stabilization |  | 8 weeks until tumor progression | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time-to-tumor progression |  | 8 weeks until tumor progression | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCC