Axitinib as Second-line Treatment for Advanced Hepatocellular Carcinoma
|ClinicalTrials.gov Identifier: NCT01273662|
Recruitment Status : Completed
First Posted : January 10, 2011
Last Update Posted : February 9, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Drug: AG-013736||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Axitinib as Second-line Treatment for Advanced Hepatocellular Carcinoma|
|Actual Study Start Date :||April 2011|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||December 2016|
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.
Other Name: Axitinib
- disease stabilization [ Time Frame: 8 weeks until tumor progression ]
- time-to-tumor progression [ Time Frame: 8 weeks until tumor progression ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01273662
|National Taiwan University Hospital|
|Taipei City, Taiwan, 100|
|Taipei Veterans General Hospital|
|Taipei City, Taiwan, 11217|
|Tri-Service General Hospital|
|Taipei City, Taiwan, 114|
|Principal Investigator:||Ann-Lii Cheng, MD, PhD||Director/Professor|