Study Of Sunitinib Malate Versus Sorafenib In Patients With Inoperable Liver Cancer

December 7, 2012 updated by: Pfizer

A Multinational, Randomized, Open-Label, Phase 3 Study Of Sunitinib Malate Versus Sorafenib In Patients With Advanced Hepatocellular Carcinoma

The study will evaluate the efficacy and safety of sunitinib (Arm A), given at 37.5 mg orally once daily, compared to sorafenib (Arm B), given orally at 400 mg twice daily, in patients with inoperable liver cancer. A total number of 1200 patients will be enrolled, 600 on Arm A and 600 on Arm B. Study treatment may be adjusted based on patient tolerance. and will be given until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. After discontinuation of study treatment, patients will be followed up in order to collect information on further antineoplastic therapy and survival.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This study was terminated on April 22th, 2010, based on a higher incidence of serious adverse events in the sunitinib arm compared to the sorafenib arm, and the fact that sunitinib did not meet the criteria to demonstrate that it was either superior or non-inferior to sorafenib in the survival of patients with advanced hepatocellular cancer. Patients on sunitinib who are judged by the investigator as receiving clinical benefit may chose to remain on study and continue treatment with sunitinib until clinical benefit as per the investigator's judgment.

Study Type

Interventional

Enrollment (Actual)

1075

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Pfizer Investigational Site
    • South Australia
      • Elizabeth Vale, South Australia, Australia, 5112
        • Pfizer Investigational Site
      • Woodville South, South Australia, Australia, 5011
        • Pfizer Investigational Site
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Pfizer Investigational Site
      • Parkville, Victoria, Australia, 3050
        • Pfizer Investigational Site
  • Belgium
      • Bruxelles, Belgium, 1070
        • Pfizer Investigational Site
      • Bruxelles, Belgium, 1200
        • Pfizer Investigational Site
      • Gent, Belgium, 900
        • Pfizer Investigational Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Pfizer Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Pfizer Investigational Site
    • Ontario
      • Kingston, Ontario, Canada, K7L 5P9
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M6R 1B5
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H2X 3J4
        • Pfizer Investigational Site
  • China
      • Beijing, China, 100071
        • Pfizer Investigational Site
      • Beijing, China, 100035
        • Pfizer Investigational Site
      • Bejing, China, 100021
        • Pfizer Investigational Site
      • Chong qing, China, 400038
        • Pfizer Investigational Site
      • Guangzhou, China, 510515
        • Pfizer Investigational Site
      • Nanjing, China, 210009
        • Pfizer Investigational Site
      • Shanghai, China, 200070
        • Pfizer Investigational Site
    • Anhui
      • Hefei, Anhui, China, 230022
        • Pfizer Investigational Site
    • Fujian
      • Fuzhou City, Fujian, China, 350014
        • Pfizer Investigational Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Pfizer Investigational Site
      • Guangzhou, Guangdong, China, 510080
        • Pfizer Investigational Site
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Pfizer Investigational Site
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Pfizer Investigational Site
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • Pfizer Investigational Site
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Pfizer Investigational Site
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Pfizer Investigational Site
      • Hangzhou, Zhejiang, China, 310022
        • Pfizer Investigational Site
  • France
      • Amiens Cedex 1, France, 80054
        • Pfizer Investigational Site
      • Bordeaux Cedex, France, 33075
        • Pfizer Investigational Site
      • Clichy Cedex, France, 92118
        • Pfizer Investigational Site
      • Creteil Cedex, France, 94010
        • Pfizer Investigational Site
      • Lille Cedex, France, 59037
        • Pfizer Investigational Site
      • Nice Cedex 2, France, 06189
        • Pfizer Investigational Site
      • Paris, France, 75012
        • Pfizer Investigational Site
      • Paris Cedex 13, France, 75651
        • Pfizer Investigational Site
      • St Herblain Cedex, France, 44805
        • Pfizer Investigational Site
      • Strasbourg Cedex, France, 67091
        • Pfizer Investigational Site
      • Toulouse, France, 31059
        • Pfizer Investigational Site
      • Vandoeuvre Les Nancy Cedex, France, 54511
        • Pfizer Investigational Site
      • Villejuif Cedex, France, 94804
        • Pfizer Investigational Site
  • Germany
      • Hamburg, Germany, 20246
        • Pfizer Investigational Site
      • Hannover, Germany, 30625
        • Pfizer Investigational Site
      • Mainz, Germany, 55131
        • Pfizer Investigational Site
      • Muenchen, Germany, 81377
        • Pfizer Investigational Site
  • Hong Kong
      • Hong Hong, Hong Kong
        • Pfizer Investigational Site
      • Kowloon, Hong Kong
        • Pfizer Investigational Site
      • Shatin, New Territories, Hong Kong
        • Pfizer Investigational Site
      • Tuen Mun, New Territories, Hong Kong
        • Pfizer Investigational Site
  • Italy
      • Bari, Italy, 70126
        • Pfizer Investigational Site
      • Bologna, Italy, 40138
        • Pfizer Investigational Site
      • Cattolica (RN), Italy, 47841
        • Pfizer Investigational Site
      • Milano, Italy, 20132
        • Pfizer Investigational Site
      • Milano, Italy, 20122
        • Pfizer Investigational Site
      • Padova, Italy, 35128
        • Pfizer Investigational Site
      • Pavia, Italy, 27100
        • Pfizer Investigational Site
      • Ravenna, Italy, 48100
        • Pfizer Investigational Site
      • Rimini, Italy, 47900
        • Pfizer Investigational Site
    • FC
      • Meldola, FC, Italy, 47014
        • Pfizer Investigational Site
  • Japan
      • Okayama, Japan
        • Pfizer Investigational Site
    • Aichi
      • Nagoya, Aichi, Japan
        • Pfizer Investigational Site
    • Chiba
      • Chiba city, Chiba, Japan
        • Pfizer Investigational Site
      • Kashiwa-shi, Chiba, Japan
        • Pfizer Investigational Site
    • Fukuoka
      • Kurume city, Fukuoka, Japan
        • Pfizer Investigational Site
    • Gifu
      • Gifu-shi, Gifu, Japan
        • Pfizer Investigational Site
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japan
        • Pfizer Investigational Site
    • Hyogo
      • Nishinomiya, Hyogo, Japan
        • Pfizer Investigational Site
    • Ishikawa
      • Kanazawa city, Ishikawa, Japan
        • Pfizer Investigational Site
    • Nagasaki
      • Omura-shi, Nagasaki, Japan
        • Pfizer Investigational Site
    • Osaka
      • Osaka-Sayama, Osaka, Japan
        • Pfizer Investigational Site
    • Osaka-fu
      • Osaka-shi, Osaka-fu, Japan
        • Pfizer Investigational Site
    • Shizuoka
      • Izunokuni-shi, Shizuoka, Japan
        • Pfizer Investigational Site
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan
        • Pfizer Investigational Site
      • Chiyoda-ku, Tokyo, Japan
        • Pfizer Investigational Site
      • Chuo-ku, Tokyo, Japan
        • Pfizer Investigational Site
      • Itabashi-ku, Tokyo, Japan
        • Pfizer Investigational Site
      • Mitaka-shi, Tokyo, Japan
        • Pfizer Investigational Site
      • Setagaya-ku, Tokyo, Japan
        • Pfizer Investigational Site
  • Korea, Republic of
      • Busan, Korea, Republic of, 614-735
        • Pfizer Investigational Site
      • Daegu, Korea, Republic of, 700-712
        • Pfizer Investigational Site
      • Daegu, Korea, Republic of, 705-718
        • Pfizer Investigational Site
      • Incheon, Korea, Republic of, 405-760
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 120-752
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 138-736
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 110-744
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 135-710
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 152-703
        • Pfizer Investigational Site
    • Chonbuk
      • Chonju, Chonbuk, Korea, Republic of, 561-712
        • Pfizer Investigational Site
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 411-769
        • Pfizer Investigational Site
    • Jeollanam-do
      • Hwasun-gun, Jeollanam-do, Korea, Republic of, 519-809
        • Pfizer Investigational Site
  • Malaysia
      • Kuala Lumpur, Malaysia, 50586
        • Pfizer Investigational Site
    • Kuala Lumpur
      • Lembah Pantai, Kuala Lumpur, Malaysia, 59100
        • Pfizer Investigational Site
    • Selangor
      • Subang Jaya, Selangor, Malaysia, 47500
        • Pfizer Investigational Site
  • Philippines
      • Cebu City, Philippines, 6000
        • Pfizer Investigational Site
      • Davao City, Philippines
        • Pfizer Investigational Site
      • Manila, Philippines, 1000
        • Pfizer Investigational Site
      • Manila, Philippines, 1015
        • Pfizer Investigational Site
      • Quezon City, Philippines, 1102
        • Pfizer Investigational Site
      • Quezon City, Philippines
        • Pfizer Investigational Site
      • Quezon City, Philippines, 1104
        • Pfizer Investigational Site
    • Cebu
      • Cebu City, Cebu, Philippines, 6000
        • Pfizer Investigational Site
  • Poland
      • Warszawa, Poland, 02-781
        • Pfizer Investigational Site
      • Warszawa, Poland, 02-097
        • Pfizer Investigational Site
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454087
        • Pfizer Investigational Site
      • Pyatigorsk, Russian Federation, 357502
        • Pfizer Investigational Site
      • St.Petersburg, Russian Federation, 194044
        • Pfizer Investigational Site
  • Singapore
      • Singapore, Singapore, 119074
        • Pfizer Investigational Site
      • Singapore, Singapore, 169610
        • Pfizer Investigational Site
  • South Africa
      • Parktown, South Africa, 2193
        • Pfizer Investigational Site
  • Spain
      • Sevilla, Spain, 41013
        • Pfizer Investigational Site
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Pfizer Investigational Site
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Pfizer Investigational Site
    • Illes Balears
      • Palma de Mallorca, Illes Balears, Spain, 07198
        • Pfizer Investigational Site
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Pfizer Investigational Site
  • Sweden
      • Linkoping, Sweden, 581 85
        • Pfizer Investigational Site
  • Taiwan
      • Changhua, Taiwan, 500
        • Pfizer Investigational Site
      • Kaohsiung, Taiwan, 807
        • Pfizer Investigational Site
      • Kaohsiung, Taiwan, 833
        • Pfizer Investigational Site
      • Taichung, Taiwan, 404
        • Pfizer Investigational Site
      • Taichung City, Taiwan, 407
        • Pfizer Investigational Site
      • Tainan, Taiwan, 736
        • Pfizer Investigational Site
      • Tainan, Taiwan, 704
        • Pfizer Investigational Site
      • Taipei, Taiwan, 112
        • Pfizer Investigational Site
      • Taipei, Taiwan, 110
        • Pfizer Investigational Site
    • Chai-Yi
      • Pu-Tz City, Chai-Yi, Taiwan, 613
        • Pfizer Investigational Site
    • Taoyuan
      • Kwei-Shan, Taoyuan, Taiwan, 333
        • Pfizer Investigational Site
  • Thailand
    • Bangkok
      • Bangkok Noi, Bangkok, Thailand, 10700
        • Pfizer Investigational Site
      • Ptumwan, Bangkok, Thailand, 10330
        • Pfizer Investigational Site
    • Chiang Mai
      • Amphoe Mueang, Chiang Mai, Thailand, 50200
        • Pfizer Investigational Site
  • Turkey
      • Ankara, Turkey, 06100
        • Pfizer Investigational Site
      • Istanbul, Turkey
        • Pfizer Investigational Site
  • United Kingdom
      • London, United Kingdom, W12 0NN
        • Pfizer Investigational Site
      • London, United Kingdom, W12 OHS
        • Pfizer Investigational Site
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CR2 0QQ
        • Pfizer Investigational Site
  • United States
    • California
      • Fountain Valley, California, United States, 92708
        • Pfizer Investigational Site
      • La Jolla, California, United States, 92037
        • Pfizer Investigational Site
      • La Jolla, California, United States, 92093
        • Pfizer Investigational Site
      • Orange, California, United States, 92868
        • Pfizer Investigational Site
      • San Diego, California, United States, 92103
        • Pfizer Investigational Site
    • Florida
      • Miami, Florida, United States, 33136
        • Pfizer Investigational Site
    • Georgia
      • Ringgold, Georgia, United States, 30736
        • Pfizer Investigational Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Pfizer Investigational Site
    • Kentucky
      • Crestview Hills, Kentucky, United States, 41017
        • Pfizer Investigational Site
    • New York
      • Bronx, New York, United States, 10467
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Pfizer Investigational Site
      • Cincinnati, Ohio, United States, 45219
        • Pfizer Investigational Site
      • Cincinnati, Ohio, United States, 45230
        • Pfizer Investigational Site
      • Cincinnati, Ohio, United States, 45236
        • Pfizer Investigational Site
      • Cincinnati, Ohio, United States, 45238
        • Pfizer Investigational Site
      • Cincinnati, Ohio, United States, 45248
        • Pfizer Investigational Site
      • Fairfield, Ohio, United States, 45014
        • Pfizer Investigational Site
      • Hamilton, Ohio, United States, 45013
        • Pfizer Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Pfizer Investigational Site
      • Franklin, Tennessee, United States, 37067
        • Pfizer Investigational Site
      • Gallatin, Tennessee, United States, 37066
        • Pfizer Investigational Site
      • Hermitage, Tennessee, United States, 37076
        • Pfizer Investigational Site
      • Hixson, Tennessee, United States, 37343
        • Pfizer Investigational Site
      • Lebanon, Tennessee, United States, 37087
        • Pfizer Investigational Site
      • Murfreesboro, Tennessee, United States, 37130
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37203
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37205
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37207
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37211
        • Pfizer Investigational Site
      • Smyrna, Tennessee, United States, 37167
        • Pfizer Investigational Site
    • Virginia
      • Mechanicsville, Virginia, United States, 23116
        • Pfizer Investigational Site
      • Midlothian, Virginia, United States, 23114
        • Pfizer Investigational Site
      • Richmond, Virginia, United States, 23230
        • Pfizer Investigational Site
      • Richmond, Virginia, United States, 23235-4730
        • Pfizer Investigational Site
    • Washington
      • Seattle, Washington, United States, 98101
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically-confirmed diagnosis of hepatocellular carcinoma
  • presence of measurable disease by radiographic imaging
  • Child-Pugh class A
  • ECOG PS 0 or 1
  • adequate organ function.

Exclusion Criteria:

  • Prior treatment with any systemic treatment for hepatocellular carcinoma
  • prior local treatment within 4 weeks from entry
  • presence of clinically relevant ascites
  • severe hemorrhage <4 weeks of starting study treatment
  • known HIV or serious acute or chronic illness
  • current treatment on another clinical trial
  • pregnancy or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
sunitinib arm
Drug: sunitinib malate
sunitinib capsules at starting dose of 37.5 mg PO daily, until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. Sunitinib dosing interruptions and/or reductions are allowed based on patient tolerability.
Other Names:
  • Sutent®
Active Comparator: Arm B
sorafenib arm
Drug: sorafenib
sorafenib tablets at starting dose of 400 mg PO twice daily, until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. Sorafenib dosing interruptions and/or reductions are allowed based on patient tolerability.
Other Names:
  • Nexavar®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150
Overall survival is the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.
Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150
The period from randomization until disease progression or death.
Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150
Time to Tumor Progression (TTP)
Time Frame: Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150
Time in weeks from randomization to first documentation of objective tumor progression or death due to cancer, whichever comes first. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD])
Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150
European Quality of Life (EQ-5D)- Health State Profile Utility Score
Time Frame: Day 1 of each cycle
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 (eg, "confined to bed"). Scoring formula assigns a utility value for each domain in the profile. Score is transformed and results in a score range -0.594 to 1.000; higher score indicates better health state.
Day 1 of each cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

June 16, 2008

First Submitted That Met QC Criteria

June 16, 2008

First Posted (Estimate)

June 18, 2008

Study Record Updates

Last Update Posted (Estimate)

January 14, 2013

Last Update Submitted That Met QC Criteria

December 7, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6181170

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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