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

Primary Purpose

Carcinoma, Hepatocellular

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
sunitinib malate
sorafenib
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring sunitinib, phase 3, randomized, hepatocellular, liver

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A

Arm B

Arm Description

sunitinib arm

sorafenib arm

Outcomes

Primary Outcome Measures

Overall Survival (OS)
Overall survival is the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.

Secondary Outcome Measures

Progression-Free Survival (PFS)
The period from randomization until disease progression or death.
Time to Tumor Progression (TTP)
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])
European Quality of Life (EQ-5D)- Health State Profile Utility Score
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.

Full Information

First Posted
June 16, 2008
Last Updated
December 7, 2012
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00699374
Brief Title
Study Of Sunitinib Malate Versus Sorafenib In Patients With Inoperable Liver Cancer
Official Title
A Multinational, Randomized, Open-Label, Phase 3 Study Of Sunitinib Malate Versus Sorafenib In Patients With Advanced Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Terminated
Why Stopped
See termination reason in detailed description.
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular
Keywords
sunitinib, phase 3, randomized, hepatocellular, liver

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1075 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
sunitinib arm
Arm Title
Arm B
Arm Type
Active Comparator
Arm Description
sorafenib arm
Intervention Type
Drug
Intervention Name(s)
sunitinib malate
Other Intervention Name(s)
Sutent®
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
sorafenib
Other Intervention Name(s)
Nexavar®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Overall survival is the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.
Time Frame
Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
The period from randomization until disease progression or death.
Time Frame
Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150
Title
Time to Tumor Progression (TTP)
Description
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])
Time Frame
Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150
Title
European Quality of Life (EQ-5D)- Health State Profile Utility Score
Description
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.
Time Frame
Day 1 of each cycle

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
35226112
Citation
Abuhelwa AY, Badaoui S, Yuen HY, McKinnon RA, Ruanglertboon W, Shankaran K, Tuteja A, Sorich MJ, Hopkins AM. A clinical scoring tool validated with machine learning for predicting severe hand-foot syndrome from sorafenib in hepatocellular carcinoma. Cancer Chemother Pharmacol. 2022 Apr;89(4):479-485. doi: 10.1007/s00280-022-04411-9. Epub 2022 Feb 28.
Results Reference
derived
PubMed Identifier
24081937
Citation
Cheng AL, Kang YK, Lin DY, Park JW, Kudo M, Qin S, Chung HC, Song X, Xu J, Poggi G, Omata M, Pitman Lowenthal S, Lanzalone S, Yang L, Lechuga MJ, Raymond E. Sunitinib versus sorafenib in advanced hepatocellular cancer: results of a randomized phase III trial. J Clin Oncol. 2013 Nov 10;31(32):4067-75. doi: 10.1200/JCO.2012.45.8372. Epub 2013 Sep 30.
Results Reference
derived
PubMed Identifier
20203173
Citation
Koeberle D, Montemurro M, Samaras P, Majno P, Simcock M, Limacher A, Lerch S, Kovacs K, Inauen R, Hess V, Saletti P, Borner M, Roth A, Bodoky G. Continuous Sunitinib treatment in patients with advanced hepatocellular carcinoma: a Swiss Group for Clinical Cancer Research (SAKK) and Swiss Association for the Study of the Liver (SASL) multicenter phase II trial (SAKK 77/06). Oncologist. 2010;15(3):285-92. doi: 10.1634/theoncologist.2009-0316. Epub 2010 Mar 4.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6181170&StudyName=Study%20Of%20Sunitinib%20Malate%20Versus%20Sorafenib%20In%20Patients%20With%20Inoperable%20Liver%20Cancer
Description
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Learn more about this trial

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

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