Study of Axitinib in Patients With Unresectable Hepatocellular Carcinoma
NCT01334112
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Unresectable and/or metastatic Hepatocellular Carcinoma
- Previous treatment with tyrosine kinase inhibitors or antiangiogenic drugs
- Life expectancy of ≥12 weeks
- At least one tumor lesion
- At least 2 weeks since the end of prior systemic treatment
- No evidence of pre-existing uncontrolled hypertension
- ECOG 0 or 1
- Adequate organ function
- Not appropriate for curative therapy
- Child A or B7 cirrhosis
- CLIP score ≤ 4
- Received any other systemic therapy for Hepatocellular Carcinoma within 2 weeks prior
to treatment
- Major surgery <4 weeks or radiation therapy <2 weeks of starting the study treatment
- Previous or concurrent cancer that is distinct in primary site or histology from
Hepatocellular Carcinoma
- Severe acute or chronic medical or psychiatric condition
- Need for treatment with prohibited drugs
- Has received local therapy to all measurable lesions
- Stage B8 or higher liver cirrhosis
- Ascites refractory to diuretic therapy
- Clinically significant ECG abnormality
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Calgary, Alberta
- Toronto, Ontario
- Montreal, Quebec
- San Francisco, California
- Chicago, Illinois
- Fountain Valley, California
- La Jolla, California
- La Jolla, California
- Orange, California
- San Diego, California
- Miami, Florida
- Ringgold, Georgia
- Iowa City, Iowa
- Crestview Hills, Kentucky
- Bronx, New York
- Cincinnati, Ohio
- Cincinnati, Ohio
- Cincinnati, Ohio
- Cincinnati, Ohio
- Cincinnati, Ohio
- Cincinnati, Ohio
- Fairfield, Ohio
- Hamilton, Ohio
- Chattanooga, Tennessee
- Franklin, Tennessee
- Gallatin, Tennessee
- Hermitage, Tennessee
- Hixson, Tennessee
- Lebanon, Tennessee
- Murfreesboro, Tennessee
- Nashville, Tennessee
- Nashville, Tennessee
- Nashville, Tennessee
- Nashville, Tennessee
- Smyrna, Tennessee
- Mechanicsville, Virginia
- Midlothian, Virginia
- Richmond, Virginia
- Richmond, Virginia
- Seattle, Washington
- Concord, New South Wales
- Elizabeth Vale, South Australia
- Woodville South, South Australia
- Melbourne, Victoria
- Parkville, Victoria
- Bruxelles,
- Bruxelles,
- Gent,
- Calgary, Alberta
- Vancouver, British Columbia
- Kingston, Ontario
- Toronto, Ontario
- Montreal, Quebec
- Hefei, Anhui
- Fuzhou City, Fujian
- Guangzhou, Guangdong
- Guangzhou, Guangdong
- Nanning, Guangxi
- Wuhan, Hubei
- Nanjing, Jiangsu
- Chengdu, Sichuan
- Hangzhou, Zhejiang
- Hangzhou, Zhejiang
- Beijing,
- Beijing,
- Bejing,
- Chong qing,
- Guangzhou,
- Nanjing,
- Shanghai,
- Amiens Cedex 1,
- Bordeaux Cedex,
- Clichy Cedex,
- Creteil Cedex,
- Lille Cedex,
- Nice Cedex 2,
- Paris Cedex 13,
- Paris,
- St Herblain Cedex,
- Strasbourg Cedex,
- Toulouse,
- Vandoeuvre Les Nancy Cedex,
- Villejuif Cedex,
- Hamburg,
- Hannover,
- Mainz,
- Muenchen,
- Hong Hong,
- Kowloon,
- Shatin, New Territories,
- Tuen Mun, New Territories,
- Meldola, FC
- Bari,
- Bologna,
- Cattolica (RN),
- Milano,
- Milano,
- Padova,
- Pavia,
- Ravenna,
- Rimini,
- Nagoya, Aichi
- Chiba city, Chiba
- Kashiwa-shi, Chiba
- Kurume city, Fukuoka
- Gifu-shi, Gifu
- Sapporo-shi, Hokkaido
- Nishinomiya, Hyogo
- Kanazawa city, Ishikawa
- Omura-shi, Nagasaki
- Osaka-shi, Osaka-fu
- Osaka-Sayama, Osaka
- Izunokuni-shi, Shizuoka
- Bunkyo-ku, Tokyo
- Chiyoda-ku, Tokyo
- Chuo-ku, Tokyo
- Itabashi-ku, Tokyo
- Mitaka-shi, Tokyo
- Setagaya-ku, Tokyo
- Okayama,
- Chonju, Chonbuk
- Goyang-si, Gyeonggi-do
- Hwasun-gun, Jeollanam-do
- Busan,
- Daegu,
- Daegu,
- Incheon,
- Seoul,
- Seoul,
- Seoul,
- Seoul,
- Seoul,
- Lembah Pantai, Kuala Lumpur
- Subang Jaya, Selangor
- Kuala Lumpur,
- Cebu City, Cebu
- Cebu City,
- Davao City,
- Manila,
- Manila,
- Quezon City,
- Quezon City,
- Quezon City,
- Warszawa,
- Warszawa,
- Chelyabinsk,
- Pyatigorsk,
- St.Petersburg,
- Singapore,
- Singapore,
- Parktown,
- Sabadell, Barcelona
- Santander, Cantabria
- Palma de Mallorca, Illes Balears
- El Palmar, Murcia
- Sevilla,
- Linkoping,
- Pu-Tz City, Chai-Yi
- Kwei-Shan, Taoyuan
- Changhua,
- Kaohsiung,
- Kaohsiung,
- Taichung City,
- Taichung,
- Tainan,
- Tainan,
- Taipei,
- Taipei,
- Bangkok Noi, Bangkok
- Ptumwan, Bangkok
- Amphoe Mueang, Chiang Mai
- Ankara,
- Istanbul,
- Cambridge, Cambridgeshire
- London,
- London,
Descriptive Information | |||||||
---|---|---|---|---|---|---|---|
Brief Title ICMJE | Study of Axitinib in Patients With Unresectable Hepatocellular Carcinoma | ||||||
Official Title ICMJE | A Phase II Trial of Axitinib (AG-013736) After Prior Antiangiogenic Therapy in Advanced Hepatocellular Carcinoma | ||||||
Brief Summary | The purpose of this study is to evaluate the potential role of Axitinib (AG-013736) in the treatment of unresectable/metastatic hepatocellular carcinoma (HCC) | ||||||
Detailed Description | This is a phase II study of an investigational drug, Axitinib following prior antiangiogenic therapy in patients with advanced hepatocellular carcinoma. Hepatocellular carcinoma (HCC) is a primary cancer of the liver. Angiogenesis is a physiological process involving the growth of new blood vessels from pre-existing vessels. A tyrosine kinase is an enzyme that can inhibit angiogenesis. In this study, patients with advanced HCC who have failed prior antiangiogenic therapy, will receive Axitinib in cycles of 4 weeks. Axitinib is an oral, potent and selective inhibitor of angiogenesis. This study will evaluate the response rate of HCC following treatment with Axitinib as well as safety, feasibility, overall survival of patients, progression-free survival, and quality of life in persons with unresectable HCC. The study also compares response determined by RECIST to response determined by Choi Criteria. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||
Condition ICMJE | Hepatocellular Carcinoma | ||||||
Intervention ICMJE | Drug: Axitinib (AG-013736)
5mg, oral, twice daily, continuous dosing. A dosing cycle is defined as 4 weeks. Treatment may continue until disease progression/relapse | ||||||
Study Arms ICMJE | Experimental: Axitinib
Oral Axitinib (5mg, twice daily) will be administered to all patients Intervention: Drug: Axitinib (AG-013736) | ||||||
Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE | 30 | ||||||
Original Estimated Enrollment ICMJE | 29 | ||||||
Actual Study Completion Date ICMJE | March 2018 | ||||||
Actual Primary Completion Date | March 2018 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||||
Sex/Gender ICMJE |
| ||||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Canada | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01334112 | ||||||
Other Study ID Numbers ICMJE | WS515376 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | University Health Network, Toronto | ||||||
Study Sponsor ICMJE | University Health Network, Toronto | ||||||
Collaborators ICMJE | Pfizer | ||||||
Investigators ICMJE |
| ||||||
PRS Account | University Health Network, Toronto | ||||||
Verification Date | December 2019 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |