Axitinib as Second-line Treatment for Advanced Hepatocellular Carcinoma

NCT ID: NCT01273662

Last Updated: 2017-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2016-12-31

Brief 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. 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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Axitinib

Group Type: EXPERIMENTAL

AG-013736

Intervention Type: DRUG

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.

Interventions

AG-013736

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.

Intervention Type: DRUG

Other Intervention Names

Axitinib

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tri-Service General Hospital

OTHER

Sponsor Role: collaborator

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ann-Lii Cheng, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Director/Professor

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

Tri-Service General Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

201008013M

Identifier Type: -

Identifier Source: org_study_id