Axitinib as Second-line Treatment for Advanced Hepatocellular Carcinoma

National Taiwan University

Status and phase

Completed

Phase 2

Conditions

Hepatocellular Carcinoma

Treatments

Drug: AG-013736

Study type

Interventional

Funder types

Other

Identifiers

NCT01273662

201008013M

Details and patient eligibility

About

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.

Full 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.

Enrollment

45 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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