Axitinib For The Treatment Of Advanced Hepatocellular Carcinoma

• ClinicalTrials.gov Identifier: NCT01210495
• Recruitment Status: Completed
• First Posted: September 28, 2010
• Results First Posted: May 27, 2015
• Last Update Posted: January 9, 2019
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hepatocellular Carcinoma	Drug: Axitinib (AG-013736); Other: Best Supportive Care; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 224 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: December 6, 2010
• Actual Primary Completion Date: March 3, 2014
• Actual Study Completion Date: December 20, 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: A; Participants 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	Drug: Axitinib (AG-013736); 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; Other: Best Supportive Care; BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life.
Placebo Comparator: B; Participants 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	Drug: Placebo; 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; Other: Best Supportive Care; BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life.

Outcome Measures

Primary Outcome Measures :

1. Overall Survival (OS) - Stratified Analysis, Randomized Portion [ Time Frame: From randomization until at least two years after the last participant has been randomized (up to 6 years) ]
   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.

Secondary Outcome Measures :

1. Progression-Free Survival (PFS) - Stratified Analysis, Randomized Portion [ Time Frame: 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 ]
   PFS was defined as time from randomization to first documented objective tumor progression or to death due to any cause, whichever occurred first. PFS (in months) was calculated as (first event date - first randomization date +1)/30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was death). As per response evaluation criteria in solid tumors (RECIST) 1.1, progression was defined as greater than or equal to (>=) 20% increase in sum of longest dimensions of target lesions or appearance of one or more new target lesions and unequivocal progression of existing non-target lesions, or appearance of 1 new non-target lesions. Participants discontinuing study treatment without documented evidence of PD were to be followed up at least every 8 weeks after discontinuing study treatment until disease progression, or initiation of another anticancer treatment.
2. Objective Response Rate (ORR) - Percentage of Participants With Objective Response by Stratified Analysis, Randomized Portion [ Time Frame: Every 8 weeks until at least two years after the last participant has been randomized ]
   ORR was defined as the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) according to the RECIST 1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must decrease to normal (short axis <10 millimetres [mm]). PR was defined as a 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
3. Time to Tumor Progression (TTP) - Stratified Analysis, Randomized Portion [ Time Frame: 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 ]
   TTP was defined as the time from randomization to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP (in months) was calculated as (first event date - first randomization date +1)/30.4.
4. Duration of Response (DR) by Unstratified Analysis, Randomized Portion [ Time Frame: From objective response to date of progression or death ]
   DR was defined as the time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of PD or to death due to any cause, whichever occurs first. If tumor progression data included more than 1 date, the first date was to be used. DR (in months) was to be calculated as (the end date for DR - first CR or PR that was subsequently confirmed +1)/30.4.
5. Percentage of Participants With Overall Clinical Benefit Response (CBR) - Stratified Analysis, Randomized Portion [ Time Frame: From Baseline up to end of treatment ]
   CBR was defined as the percentage of participants with confirmed CR or confirmed PR or a best response of stable disease >=8 weeks according to RECIST 1.1 criteria, relative to all randomized participants who had baseline measurable disease. Confirmed responses were defined as those that persisted on repeat imaging study >=4 weeks after the initial documentation of response. Participants who did not have on study radiographic tumor re-evaluation or who died, progressed, or dropped out for any reason prior to reaching a CR, PR, or stable disease were counted as non-responders in the assessment of CBR. A participant who initially met the criteria for a PR and then subsequently became a confirmed CR was to be assigned a best response of CR.
6. Axitinib Steady-State Pharmacokinetic (PK) Parameter - Maximum Observed Plasma Concentration (Cmax), Non-Randomized Portion [ Time Frame: Cycle 1 Day 15 ]
   Axitinib samples were to be collected from all participants on Cycle 1 Day 15 at the following time points: pre-dose, 1, 2, 3, 4, 6 and 8 hours after axitinib dosing.
7. Axitinib Steady-State PK Parameter - Area Under the Plasma Concentration Versus Time Curve From 0 to 24 Hour (AUC0-24), Non-Randomized Portion [ Time Frame: Cycle 1 Day 15 ]
   Axitinib samples were to be collected from all participants on Cycle 1 Day 15 at the following time points: pre-dose, 1, 2, 3, 4, 6 and 8 hours after axitinib dosing. In the below table, 4 participants in Child-Pugh A and 1 participant in Child-Pugh B were not reported due to nonestimable half-life.
8. Axitinib Steady-State Pharmacokinetic Parameter - Time to First Occurrence of Cmax (Tmax), Non-Randomized Portion [ Time Frame: Cycle 1 Day 15 ]
   Axitinib samples were to be collected from all participants on Cycle 1 Day 15 at the following time points: pre-dose, 1, 2, 3, 4, 6 and 8 hours after axitinib dosing.
9. Axitinib Steady-State Pharmacokinetic Parameter - Apparent Oral Clearance (CL/F), Non-Randomized Portion [ Time Frame: Cycle 1 Day 15 ]
   Axitinib samples were to be collected from all participants on Cycle 1 Day 15 at the following time points: pre-dose, 1, 2, 3, 4, 6 and 8 hours after axitinib dosing. In the below table, 4 participants in Child-Pugh A and 1 participant in Child-Pugh B were not reported due to nonestimable half-life.
10. Axitinib Steady-State Pharmacokinetic Parameter - Terminal Plasma Elimination Half-Life (t1/2), Non-Randomized Portion [ Time Frame: Cycle 1 Day 15 ]
    Axitinib samples were to be collected from all participants on Cycle 1 Day 15 at the following time points: pre-dose, 1, 2, 3, 4, 6 and 8 hours after axitinib dosing. In the below table, 4 participants in Child-Pugh A and 1 participant in Child-Pugh B were not reported due to nonestimable half-life.
11. Axitinib Steady-State Pharmacokinetic Parameter - Apparent Oral Volume of Distribution of the Drug During the Elimination Phase (Vz/F), Non-Randomized Portion [ Time Frame: Cycle 1 Day 15 ]
    Axitinib samples were to be collected from all participants on Cycle 1 Day 15 at the following time points: pre-dose, 1, 2, 3, 4, 6 and 8 hours after axitinib dosing. The PK parameter, Vz/F has been presented in this outcome measure. In the below table, 4 participants in Child-Pugh A and 1 participant in Child-Pugh B were not reported due to nonestimable half-life.
12. Concentration of Soluble Proteins at Baseline in Randomized Portion [ Time Frame: Baseline ]
    Plasma soluble proteins interleukin-6 (IL-6), E-Selectin, interleukin-8 (IL-8), hepatocyte growth factor (HGF), matrix metalloproteinase-2 (MMP-2), stem cell factor (SCF), angiopoietin-2 (Ang-2), vascular endothelial growth factor-A (VEGF-A), vascular endothelial growth factor-C (VEGF-C), soluble vascular endothelial growth factor receptor 2 (sVEGFR2), soluble vascular endothelial growth factor receptor 3 (sVEGFR3), stromal cell-derived factor-1 (SDF1), neutrophil gelatinase-associated lipocalin (NGAL), migration inhibitory factor (MIF), c-MET, regulated upon activation normal T cell expressed and presumably secreted (RANTES), and monocyte chemotactic protein-3 (MCP-3) were only measured in randomized participants.
13. Percentage of Participants With Specific Micro-Ribonucleic Acid (miRNA) Transcript Present in Circulation in Randomized Portion [ Time Frame: Baseline ]
    A 5 millilitres (mL) whole blood sample was collected from all randomized participants to evaluate the miRNA transcripts.
14. Functional Assessment of Cancer Therapy - Hepatobiliary Questionnaire (FACT-Hep) in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model [ Time Frame: Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date ]
    FACT-Hep consists of 27-item FACT-G, and 18-item Hepatobiliary Subscale. FACT-Hep questionnaire uses 5-point Likert rating scale, range '0'-not at all to '4'. FACT-Hep total score ranges from 0 to 180, where highest score represents maximum achievable quality of life. Domains of FACT-G include Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB). Hepatobiliary disease specific items include: swelling or cramps, losing weight, gastrointestinal (GI)-related questions, lack of energy, side effects, pain, fatigue, usual activities, jaundice, fevers, itching, taste of food and chills. Eight of the items (pain, back pain, stomach pain/discomfort, lack of energy, fatigue, nausea, weight loss and jaundice) make up FACT-Hepatobiliary Symptom Index (FHSI-8), and are considered to be symptoms specific to hepatobiliary cancer. Table below included mixed effect model estimated average based on all observed values/time points.
15. Functional Assessment of Cancer Therapy - General (FACT-G) in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model [ Time Frame: Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date ]
    FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate QoL in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL (HRQoL): PWB, SWB, EWB and FWB; each ranging from 0 (not at all) to 4 (very much). FACT-G ranged between 0 and 108. Since questions could be reversed coded, as appropriate, before calculating FACT-G, 0 and 108 could be considered worst and best health states. The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.
16. Functional Assessment of Cancer Therapy (FACT)-Hepatobiliary Symptom Index-8 (FHSI-8) in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model [ Time Frame: Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date ]
    The FACT-Hep includes the FACT-G and a hepatobiliary module. The hepatobiliary disease specific items include: swelling or cramps, losing weight, GI related questions, lack of energy, side effects, pain, fatigue, usual activities, jaundice, fevers, itching, taste of food and chills. Eight of the items (pain, back pain, stomach pain/discomfort, lack of energy, fatigue, nausea, weight loss, and jaundice) make up the FHSI-8, and are considered to be symptoms specific to hepatobiliary cancer. FHSI-8 total score ranges from 0 to 32 where "0" is a severely symptomatic participant and the highest score indicates an asymptomatic participant. The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.
17. Functional Assessment of Cancer Therapy-G (FACT-G) Subscales in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model [ Time Frame: Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date ]
    FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate QoL in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general HRQoL: PWB, SWB, EWB and FWB. Each of the individual subscale, except EWB has 7 items and each integer scored 0 to 4 making a maximum possible score of 28 (range 0 to 28). EWB has 6 items and each integer scored 0 to 4 making a maximum possible score of 24 (range 0 to 24). For all the 4 scales, higher values correspond to better health. The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.
18. Functional Assessment of Cancer Therapy - Hepatobiliary Cancer Subscale (FACT Hep-CS18) Questionnaire in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model [ Time Frame: Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date ]
    This subscale consists of 18 items rated on a scale from '0' - not at all to '4' - very much regarding how much each item was present in the last 7 days. FACT-Hep-CS18 total score ranges from 0 to 72. The higher score reflects better QoL or fewer symptoms. The 18 items of this scale are associated with hepatocellular carcinoma. The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.
19. Functional Assessment of Cancer Therapy - Hepatobiliary Cancer Trial Outcome Index (FACT Hep-TOI) Questionnaire in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model [ Time Frame: Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date ]
    The trial outcome index is defined to be the sum (PWB+FWB+HepCS), making it 32 items altogether. Each ranges from '0' - not at all to '4' - very much regarding how much each item was present in the last 7 days. FACT Hep -TOI total score ranges from 0 to 128, where the highest score represents a maximum achievable quality of life. The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.
20. Time to Deterioration (TTD) Based on the Composite Endpoint in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model [ Time Frame: From randomization to death or tumor progression or FHSI-8 mean score decrease >=3 points, whichever comes first ]
    TTD analysis was performed for FHSI-8. Time to deterioration was defined as the time between date of randomization and date of the event.
21. EuroQoL (EQ-5D)- Health State Profile Utility Score in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model [ Time Frame: Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date ]
    EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.
22. EuroQoL Visual Analogue Scale (EQ-VAS) in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model [ Time Frame: Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date ]
    EQ-5D VAS in rates the participant's overall health status using values from 0 (worst imaginable) to 100 (best imaginable). The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.
23. Number of Participants With Dose-Limiting Toxicities (DLTs) in Non-Randomized Portion [ Time Frame: Cycle 1 (4 weeks) ]
    Number of Child-Pugh Class B (score 7) participants with DLT was evaluated during Cycle 1 of treatment in the non-randomized portion of the study.
24. Number of Participants With Treatment-Emergent Adverse Events (AEs) in Non-Randomized Portion [ Time Frame: Up to 28 days after last dose of study drug (up to 6 years) ]
    An AE was an untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes: death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. The grade of an AE was determined according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.
25. Number of Participants With Treatment-Related Adverse Events (AEs) in Non-Randomized Portion [ Time Frame: Up to 28 days after last dose of study drug (up to 6 years) ]
    Treatment-related AE was any untoward medical occurrence in a participant with causal relationship to the study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The grade of an AE was determined according to CTCAE Version 3.0.
26. Number of Participants With Treatment-Emergent Adverse Events (AEs) in Randomized Portion [ Time Frame: Up to 28 days after last dose of study drug (up to 6 years) ]
    An AE was an untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes: death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. The grade of an AE was determined according to CTCAE Version 3.0.
27. Number of Participants With Treatment-Related Adverse Events (AEs) in Randomized Portion [ Time Frame: Up to 28 days after last dose of study drug (up to 6 years) ]
    Treatment-related AE was any untoward medical occurrence in a participant with causal relationship to the study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The grade of an AE was determined according to CTCAE Version 3.0.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

United States, California

Alta Bates Summit Comprehensive Cancer Center

Berkeley, California, United States, 94704

UCSD Medical Center- La Jolla

La Jolla, California, United States, 92037

Moores UCSD Cancer Center

La Jolla, California, United States, 92093

University of California Irvine Medical Center

Orange, California, United States, 92868

UCSD Medical Center- Hillcrest

San Diego, California, United States, 92103

United States, Florida

Florida Hospital Transplant Center, Liver Unit

Orlando, Florida, United States, 32804

Moffitt Cancer Center & Research Institute

Tampa, Florida, United States, 33612

United States, Michigan

University of Michigan

Ann Arbor, Michigan, United States, 48109

United States, Nebraska

Nebraska Methodist Hospital

Omaha, Nebraska, United States, 68114

United States, Nevada

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States, 86169

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States, 89119

United States, Pennsylvania

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States, 19104

Belgium

Universitair Ziekenhuis Gent

Gent, Belgium, 9000

CHC Clinique Saint-Joseph

Liège, Belgium, 4000

China, Anhui

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China, 230022

China, Guangdong

Guangdong General Hospital

Guangzhou, Guangdong, China, 510080

China, Jiangsu

Nanjing Bayi Hospital

Nan Jing, Jiangsu, China, 210002

Jiang Su Cancer Hospital

Nanjing, Jiangsu, China, 210009

China, Zhejiang

Sir Run Run Shaw Hospital of College of Medicine of Zhejiang University

Hangzhou, Zhejiang, China, 310016

China

The PLA 307 Hospital

Beijing, China, 100071

Zhongshan Hospital Fudan University

Shanghai, China, 200032

France

Centre Hospitalier Universitaire d'Amiens

Amiens, France, 80054

Hopital Saint André

Bordeaux Cedex, France, 33075

CHU Cote de Nacre

Caen, cedex 05, France, 14033

Bichat-Beaujon Service Inter Hospitalier De Cancerologie

Clichy, France, 92118

Hopital De La Croix-Rousse

Lyon Cedex 04, France, 69317

UPCET-CIC Timone

Marseille, France, 13005

CHRU Montpellier-Hopital Saint Eloi - Departement Oncologie Medicale

Montpellier Cedex 05, France, 34295

Hôpital L'Archet Ii

Nice, France, 06200

Hôpital Saint Antoine

Paris, France, 75012

Centre Eugène Marquis

Rennes, France, 35042

CHRU de Purpan.

Toulouse Cedex, France, 31059

Germany

Medizinische Klinik mit Schwerpunkt

Berlin, Germany, 13353

Universitätsklinikum Bonn

Bonn, Germany, 53105

Klinikum der Ludwig-Maximilians-Universitaet , Campus Grosshadern

München, Germany, 81377

Hong Kong

Queen Mary Hospital

Hong Kong, Hong Kong

Prince of Wales Hospital

Shatin, N.T., Hong Kong

Hungary

Semmelweis Egyetem I.sz. Belgyógyászati Klinika

Budapest, Hungary, 1083

Szegedi Tudományegyetem Onkoterápiás Klinika

Szeged, Hungary, 6720

Italy

Istituto di Ematologia ed Oncologia Medica, Lorenzo ed Ariosto Seragnoli,

Bologna, Italy, 40138

Policlinico S.Orsola-Malpighi Dipartimento di Ematologia e Scienze Oncologiche "L. E A. Seragnoli"

Bologna, Italy, 40138

Ospedale Versilia,Oncologia Medica

Lido Di Camaiore (LU), Italy, 55043

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori IRST

Meldola (FC), Italy, 47014

Unita Operativa Oncologia Medica IRCCS Fondazione Salvatore Maugeri

Pavia, Italy, 27100

Policlinico Universitario Agostino Gemelli

Roma, Italy, 00168

Unità Operativa Oncologica Medica

Roma, Italy, 00168

Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria aile Scotte

Siena, Italy, 53100

Japan

Aichi Cancer Center Central Hospital, Diagnostic and Interventional Radiology

Nagoya, Aichi, Japan, 464-8681

Chiba University Hospital

Chiba City, Chiba, Japan, 260-0858

Gifu Municipal Hospital

Gifu-shi, Gifu, Japan, 5008513

Kanazawa University Hospital

Kanazawa, Ishikawa, Japan, 920-8641

Kinki University Hospital

Osaka-Sayama, Osaka, Japan, 589-8511

Shizuoka Cancer Center

Suntou-gun, Shizuoka, Japan, 411-8777

Sasaki Foundation Kyoundo Hospital

Chiyoda-Ku, Tokyo, Japan, 1010062

Nihon University Itabashi Hospital

Itabashi-Ku, Tokyo, Japan, 173-8610

Yamanashi Prefectural Central Hospital

Kofu-Shi, Japan, 400-8506

Korea, Republic of

National Cancer Center/ Center for Liver Cancer

Goyang-si, Korea, Republic of, 410-769

Samsung Medical Center, Division of Hematology-Oncology, Department of Medicine

Seoul, Korea, Republic of, 135-710

Asan Medical Center, Division of Oncology, Department of Internal Medicine

Seoul, Korea, Republic of, 138-736

Slovakia

Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska Bystrica

Banska Bystrica, Slovakia, 975 17

Narodny onkologicky ustav

Bratislava, Slovakia, 833 10

POKO Poprad s.r.o.

Poprad, Slovakia, 058 01

Nemocnica Poprad, a.s.

Poprad, Slovakia, 058 45

Taiwan

Changhua Christian Hospital

Changhua, Taiwan, 500

Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital

Kaohsiung, Taiwan, 833

Taichung Veterans General Hospital

Taichung, Taiwan, 40705

National Cheng Kung University Hospital

Tainan, Taiwan, 704

Chi-Mei Medical Center LiouYing

Tainan, Taiwan, 736

National Taiwan University Hospital

Taipei, Taiwan, 100

Chang Gung Medical Foundation Linkou Branch

Taoyuan, Taiwan, 333

United Kingdom

The Christie NHS Foundation Trust

Withington, Manchester, United Kingdom, M20 9BX

Clatterbridge Centre for Oncology NHS Foundation Trust

Liverpool, United Kingdom, L6 7BA

Royal Liverpool and Broadgreen University Hospital

Liverpool, United Kingdom, L69 3GA

Royal Free Hospital

London, United Kingdom, NW3 2QG

King's College Hospital NHS Foundation Trust

London, United Kingdom, SE5 9RS

Hammersmith Hospital

London, United Kingdom, W12 OHS

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01210495
• Other Study ID Numbers: A4061058; 2010-021590-37 ( EudraCT Number )
• First Posted: September 28, 2010
• Results First Posted: May 27, 2015
• Last Update Posted: January 9, 2019
• Last Verified: December 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: 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.
• URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Keywords provided by Pfizer:

Hepatocellular Carcinoma

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; Axitinib; Antineoplastic Agents; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action