Axitinib as Second-line Treatment for Advanced Hepatocellular Carcinoma
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|