Axitinib For The Treatment Of Advanced Hepatocellular Carcinoma
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
2 other identifiers
interventional
224
13 countries
77
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hepatocellular-carcinoma
Started Dec 2010
Longer than P75 for phase_2 hepatocellular-carcinoma
77 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2010
CompletedFirst Posted
Study publicly available on registry
September 28, 2010
CompletedStudy Start
First participant enrolled
December 6, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 3, 2014
CompletedResults Posted
Study results publicly available
May 27, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2016
CompletedJanuary 9, 2019
December 1, 2018
3.2 years
September 22, 2010
March 3, 2015
December 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS) - Stratified Analysis, Randomized Portion
OS was defined as the time from the date of randomization to the date of death due to any cause. OS (in months) was calculated as (date of death - first randomization date +1)/30.4. For participants still alive at the time of the analysis, the OS time was censored on the last date they were known to be alive. All participants were followed up for survival at least every 3 months after discontinuing study treatment until at least two years after randomization of the last participant.
From randomization until at least two years after the last participant has been randomized (up to 6 years)
Secondary Outcomes (27)
Progression-Free Survival (PFS) - Stratified Analysis, Randomized Portion
Every 8 weeks until disease progression/death or start of new treatment or until at least two years after the last participant has been randomized, whatever occurs first
Objective Response Rate (ORR) - Percentage of Participants With Objective Response by Stratified Analysis, Randomized Portion
Every 8 weeks until at least two years after the last participant has been randomized
Time to Tumor Progression (TTP) - Stratified Analysis, Randomized Portion
Every 8 weeks until disease progression/death or start of new treatment or until at least two years after the last participant has been randomized, whatever occurs first
Duration of Response (DR) by Unstratified Analysis, Randomized Portion
From objective response to date of progression or death
Percentage of Participants With Overall Clinical Benefit Response (CBR) - Stratified Analysis, Randomized Portion
From Baseline up to end of treatment
- +22 more secondary outcomes
Study Arms (2)
A
EXPERIMENTALParticipants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration
B
PLACEBO COMPARATORParticipants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study
Interventions
Axitinib \[tablet, 1 mg, 5 mg\] will be given twice daily \[BID\] with continuous dosing; duration is approximately 3-6 months; starting dose is 5 mg BID
BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life.
Placebo \[tablet, 1 mg, 5 mg\] will be given twice daily \[BID\] with continuous dosing; duration is approximately 3-6 months; starting dose is 5 mg BID
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (77)
Alta Bates Summit Comprehensive Cancer Center
Berkeley, California, 94704, United States
UCSD Medical Center- La Jolla
La Jolla, California, 92037, United States
Moores UCSD Cancer Center
La Jolla, California, 92093, United States
University of California Irvine Medical Center
Orange, California, 92868, United States
UCSD Medical Center- Hillcrest
San Diego, California, 92103, United States
Florida Hospital Transplant Center, Liver Unit
Orlando, Florida, 32804, United States
Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 86169, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89119, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104, United States
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
CHC Clinique Saint-Joseph
Liège, 4000, Belgium
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022, China
Guangdong General Hospital
Guangzhou, Guangdong, 510080, China
Nanjing Bayi Hospital
Nanjing, Jiangsu, 210002, China
Jiang Su Cancer Hospital
Nanjing, Jiangsu, 210009, China
Sir Run Run Shaw Hospital of College of Medicine of Zhejiang University
Hangzhou, Zhejiang, 310016, China
The PLA 307 Hospital
Beijing, 100071, China
Zhongshan Hospital Fudan University
Shanghai, 200032, China
Centre Hospitalier Universitaire d'Amiens
Amiens, 80054, France
Hopital Saint André
Bordeaux, 33075, France
CHU Cote de Nacre
Caen, 14033, France
Bichat-Beaujon Service Inter Hospitalier De Cancerologie
Clichy, 92118, France
Hopital De La Croix-Rousse
Lyon, 69317, France
UPCET-CIC Timone
Marseille, 13005, France
CHRU Montpellier-Hopital Saint Eloi - Departement Oncologie Medicale
Montpellier, 34295, France
Hôpital L'Archet Ii
Nice, 06200, France
Hôpital Saint Antoine
Paris, 75012, France
Centre Eugène Marquis
Rennes, 35042, France
CHRU de Purpan.
Toulouse, 31059, France
Medizinische Klinik mit Schwerpunkt
Berlin, 13353, Germany
Universitätsklinikum Bonn
Bonn, 53105, Germany
Klinikum der Ludwig-Maximilians-Universitaet , Campus Grosshadern
München, 81377, Germany
Prince of Wales Hospital
Shatin, N.T., HONG KONG, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Semmelweis Egyetem I.sz. Belgyógyászati Klinika
Budapest, 1083, Hungary
Szegedi Tudományegyetem Onkoterápiás Klinika
Szeged, 6720, Hungary
Istituto di Ematologia ed Oncologia Medica, Lorenzo ed Ariosto Seragnoli,
Bologna, 40138, Italy
Policlinico S.Orsola-Malpighi Dipartimento di Ematologia e Scienze Oncologiche "L. E A. Seragnoli"
Bologna, 40138, Italy
Ospedale Versilia,Oncologia Medica
Lido Di Camaiore (LU), 55043, Italy
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori IRST
Meldola (FC), 47014, Italy
Unita Operativa Oncologia Medica IRCCS Fondazione Salvatore Maugeri
Pavia, 27100, Italy
Policlinico Universitario Agostino Gemelli
Roma, 00168, Italy
Unità Operativa Oncologica Medica
Roma, 00168, Italy
Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria aile Scotte
Siena, 53100, Italy
Aichi Cancer Center Central Hospital, Diagnostic and Interventional Radiology
Nagoya, Aichi-ken, 464-8681, Japan
Chiba University Hospital
Chiba, Chiba, 260-0858, Japan
Gifu Municipal Hospital
Gifu, Gifu, 5008513, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641, Japan
Kinki University Hospital
Ōsaka-sayama, Osaka, 589-8511, Japan
Shizuoka Cancer Center
Suntou-gun, Shizuoka, 411-8777, Japan
Sasaki Foundation Kyoundo Hospital
Chiyoda-Ku, Tokyo, 1010062, Japan
Nihon University Itabashi Hospital
Itabashi-Ku, Tokyo, 173-8610, Japan
Yamanashi Prefectural Central Hospital
Kofu, 400-8506, Japan
Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska Bystrica
Banská Bystrica, 975 17, Slovakia
Narodny onkologicky ustav
Bratislava, 833 10, Slovakia
POKO Poprad s.r.o.
Poprad, 058 01, Slovakia
Nemocnica Poprad, a.s.
Poprad, 058 45, Slovakia
National Cancer Center/ Center for Liver Cancer
Goyang-si, 410-769, South Korea
Samsung Medical Center, Division of Hematology-Oncology, Department of Medicine
Seoul, 135-710, South Korea
Asan Medical Center, Division of Oncology, Department of Internal Medicine
Seoul, 138-736, South Korea
Changhua Christian Hospital
Changhua, 500, Taiwan
Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
Chi-Mei Medical Center LiouYing
Tainan, 736, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Chang Gung Medical Foundation Linkou Branch
Taoyuan District, 333, Taiwan
The Christie NHS Foundation Trust
Withington, Manchester, M20 9BX, United Kingdom
Clatterbridge Centre for Oncology NHS Foundation Trust
Liverpool, L6 7BA, United Kingdom
Royal Liverpool and Broadgreen University Hospital
Liverpool, L69 3GA, United Kingdom
Royal Free Hospital
London, NW3 2QG, United Kingdom
King's College Hospital NHS Foundation Trust
London, SE5 9RS, United Kingdom
Hammersmith Hospital
London, W12 OHS, United Kingdom
Related Publications (1)
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.
PMID: 26386123DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2010
First Posted
September 28, 2010
Study Start
December 6, 2010
Primary Completion
March 3, 2014
Study Completion
December 20, 2016
Last Updated
January 9, 2019
Results First Posted
May 27, 2015
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.