Axitinib as Second-line Treatment for Advanced Hepatocellular Carcinoma
This study is currently recruiting participants.
Verified April 2013 by National Taiwan University Hospital
Sponsor:
National Taiwan University Hospital
Collaborators:
Tri-Service General Hospital
Taipei Veterans General Hospital,Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01273662
First received: January 6, 2011
Last updated: May 1, 2013
Last verified: April 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Hepatocellular Carcinoma |
Drug: AG-013736 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Axitinib as Second-line Treatment for Advanced Hepatocellular Carcinoma |
Resource links provided by NLM:
Further study details as provided by National Taiwan University Hospital:
Primary Outcome Measures:
- disease stabilization [ Time Frame: 8 weeks until tumor progression ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- time-to-tumor progression [ Time Frame: 8 weeks until tumor progression ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 45 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Axitinib |
Drug: 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.
Other Name: Axitinib
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01273662
Contacts
| Contact: Ann-Lii Cheng, MD, PhD | 886-2-23123456 ext 67251 | alcheng@ntu.edu.tw |
| Contact: Chiun Hsu, MD, PhD | 886-2-23123456 ext 67009 | chsu1967@ntu.edu.tw |
Locations
| Taiwan | |
| National Taiwan University Hospital | Recruiting |
| Taipei City, Taiwan, 100 | |
| Contact: Ann-Lii Cheng, MD,PhD 886-2-23123456 ext 67251 alcheng@ntu.edu.tw | |
| Contact: Chiun Hsu, MD, PhD 886-2-23123456 ext 67009 chsu1967@ntu.edu.tw | |
| Principal Investigator: Ann-Lii Cheng, MD, PhD | |
| Sub-Investigator: Chiun Hsu, MD, PhD | |
| Sub-Investigator: Chih-Hung Hsu, MD, PhD | |
| Sub-Investigator: Zhong-Zhe Lin, MD | |
| Sub-Investigator: Ying-Chun Shen, MD | |
| Sub-Investigator: Ting-Fang Shih, MD | |
| Taipei Veterans General Hospital | Recruiting |
| Taipei City, Taiwan, 11217 | |
| Contact: Yee Chao, MD, PhD 886-2-28757270 ext 7618 ychao@vghtpe.gov.tw | |
| Principal Investigator: Yee Chao, MD, PhD | |
| Tri-Service General Hospital | Recruiting |
| Taipei City, Taiwan, 114 | |
| Contact: Yeu-Chin Chen, MD 886-2-87927208 yeuchin99@gmail.com | |
| Principal Investigator: Yeu-Chin Chen, MD | |
Sponsors and Collaborators
National Taiwan University Hospital
Tri-Service General Hospital
Taipei Veterans General Hospital,Taiwan
Investigators
| Principal Investigator: | Ann-Lii Cheng, MD, PhD | Director/Professor |
More Information
No publications provided
| Responsible Party: | National Taiwan University Hospital |
| ClinicalTrials.gov Identifier: | NCT01273662 History of Changes |
| Other Study ID Numbers: | 201008013M |
| Study First Received: | January 6, 2011 |
| Last Updated: | May 1, 2013 |
| Health Authority: | United States: Food and Drug Administration Taiwan: Department of Health |
Keywords provided by National Taiwan University Hospital:
|
HCC |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |
ClinicalTrials.gov processed this record on June 18, 2013