Axitinib For The Treatment Of Advanced Hepatocellular Carcinoma
NCT01210495
ABOUT THIS STUDY
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- Locally advanced or metastatic HCC
- Failure of one prior antiangiogenic therapy including sorafenib, bevacizumab and brivanib.
- Child-Pugh Class A or B (score 7 only) disease.
- Prior treatment of advanced HCC with more than one prior first-line systemic therapy.
- Any prior local therapy within 2 weeks of starting the study treatment.
- Presence of hepatic encephalopathy and/or clinically relevant ascites.
- Presence of main portal vein invasion by HCC.
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Descriptive Information | |||||||
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Brief Title ICMJE | Axitinib For The Treatment Of Advanced Hepatocellular Carcinoma | ||||||
Official Title ICMJE | A MULTICENTER, GLOBAL, RANDOMIZED, DOUBLE-BLIND STUDY OF AXITINIB PLUS BEST SUPPORTIVE CARE VERSUS PLACEBO PLUS BEST SUPPORTIVE CARE IN PATIENTS WITH ADVANCED HEPATOCELLULAR CARCINOMA FOLLOWING FAILURE OF ONE PRIOR ANTIANGIOGENIC THERAPY | ||||||
Brief Summary | The study is designed to demonstrate that axitinib plus best supportive care is superior to placebo plus best supportive care in prolonging survival in patients with advanced hepatocellular carcinoma. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | ||||||
Condition ICMJE | Hepatocellular Carcinoma | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Kang YK, Yau T, Park JW, Lim HY, Lee TY, Obi S, Chan SL, Qin S, Kim RD, Casey M, Chen C, Bhattacharyya H, Williams JA, Valota O, Chakrabarti D, Kudo M. Randomized phase II study of axitinib versus placebo plus best supportive care in second-line treatment of advanced hepatocellular carcinoma. Ann Oncol. 2015 Dec;26(12):2457-63. doi: 10.1093/annonc/mdv388. Epub 2015 Sep 18. | ||||||
* 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 | 224 | ||||||
Original Estimated Enrollment ICMJE | 222 | ||||||
Actual Study Completion Date ICMJE | December 20, 2016 | ||||||
Actual Primary Completion Date | March 3, 2014 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 | Belgium, China, France, Germany, Hong Kong, Hungary, Italy, Japan, Korea, Republic of, Slovakia, Taiwan, United Kingdom, United States | ||||||
Removed Location Countries | Singapore | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01210495 | ||||||
Other Study ID Numbers ICMJE | A4061058 2010-021590-37 ( EudraCT Number ) | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | December 2018 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |