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

Carcinoma, Hepatocellular Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00699374
• Other study ID #: A6181170
• Status: Terminated
• Phase: Phase 3
• First received: June 16, 2008
• Last updated: December 7, 2012
• Start date: July 2008
• Est. completion date: December 2011

Study information

• Verified date: December 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1075
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular

Intervention

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.
• 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.

Locations

Country	Name	City	State
Australia	Pfizer Investigational Site	Concord	New South Wales
Australia	Pfizer Investigational Site	Elizabeth Vale	South Australia
Australia	Pfizer Investigational Site	Melbourne	Victoria
Australia	Pfizer Investigational Site	Parkville	Victoria
Australia	Pfizer Investigational Site	Woodville South	South Australia
Belgium	Pfizer Investigational Site	Bruxelles
Belgium	Pfizer Investigational Site	Bruxelles
Belgium	Pfizer Investigational Site	Gent
Canada	Pfizer Investigational Site	Calgary	Alberta
Canada	Pfizer Investigational Site	Kingston	Ontario
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Vancouver	British Columbia
China	Pfizer Investigational Site	Beijing
China	Pfizer Investigational Site	Beijing
China	Pfizer Investigational Site	Bejing
China	Pfizer Investigational Site	Chengdu	Sichuan
China	Pfizer Investigational Site	Chong qing
China	Pfizer Investigational Site	Fuzhou City	Fujian
China	Pfizer Investigational Site	Guangzhou	Guangdong
China	Pfizer Investigational Site	Guangzhou	Guangdong
China	Pfizer Investigational Site	Guangzhou
China	Pfizer Investigational Site	Hangzhou	Zhejiang
China	Pfizer Investigational Site	Hangzhou	Zhejiang
China	Pfizer Investigational Site	Hefei	Anhui
China	Pfizer Investigational Site	Nanjing	Jiangsu
China	Pfizer Investigational Site	Nanjing
China	Pfizer Investigational Site	Nanning	Guangxi
China	Pfizer Investigational Site	Shanghai
China	Pfizer Investigational Site	Wuhan	Hubei
France	Pfizer Investigational Site	Amiens Cedex 1
France	Pfizer Investigational Site	Bordeaux Cedex
France	Pfizer Investigational Site	Clichy Cedex
France	Pfizer Investigational Site	Creteil Cedex
France	Pfizer Investigational Site	Lille Cedex
France	Pfizer Investigational Site	Nice Cedex 2
France	Pfizer Investigational Site	Paris
France	Pfizer Investigational Site	Paris Cedex 13
France	Pfizer Investigational Site	St Herblain Cedex
France	Pfizer Investigational Site	Strasbourg Cedex
France	Pfizer Investigational Site	Toulouse
France	Pfizer Investigational Site	Vandoeuvre Les Nancy Cedex
France	Pfizer Investigational Site	Villejuif Cedex
Germany	Pfizer Investigational Site	Hamburg
Germany	Pfizer Investigational Site	Hannover
Germany	Pfizer Investigational Site	Mainz
Germany	Pfizer Investigational Site	Muenchen
Hong Kong	Pfizer Investigational Site	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
Italy	Pfizer Investigational Site	Bari
Italy	Pfizer Investigational Site	Bologna
Italy	Pfizer Investigational Site	Cattolica (RN)
Italy	Pfizer Investigational Site	Meldola	FC
Italy	Pfizer Investigational Site	Milano
Italy	Pfizer Investigational Site	Milano
Italy	Pfizer Investigational Site	Padova
Italy	Pfizer Investigational Site	Pavia
Italy	Pfizer Investigational Site	Ravenna
Italy	Pfizer Investigational Site	Rimini
Japan	Pfizer Investigational Site	Bunkyo-ku	Tokyo
Japan	Pfizer Investigational Site	Chiba city	Chiba
Japan	Pfizer Investigational Site	Chiyoda-ku	Tokyo
Japan	Pfizer Investigational Site	Chuo-ku	Tokyo
Japan	Pfizer Investigational Site	Gifu-shi	Gifu
Japan	Pfizer Investigational Site	Itabashi-ku	Tokyo
Japan	Pfizer Investigational Site	Izunokuni-shi	Shizuoka
Japan	Pfizer Investigational Site	Kanazawa city	Ishikawa
Japan	Pfizer Investigational Site	Kashiwa-shi	Chiba
Japan	Pfizer Investigational Site	Kurume city	Fukuoka
Japan	Pfizer Investigational Site	Mitaka-shi	Tokyo
Japan	Pfizer Investigational Site	Nagoya	Aichi
Japan	Pfizer Investigational Site	Nishinomiya	Hyogo
Japan	Pfizer Investigational Site	Okayama
Japan	Pfizer Investigational Site	Omura-shi	Nagasaki
Japan	Pfizer Investigational Site	Osaka-Sayama	Osaka
Japan	Pfizer Investigational Site	Osaka-shi	Osaka-fu
Japan	Pfizer Investigational Site	Sapporo-shi	Hokkaido
Japan	Pfizer Investigational Site	Setagaya-ku	Tokyo
Korea, Republic of	Pfizer Investigational Site	Busan
Korea, Republic of	Pfizer Investigational Site	Chonju	Chonbuk
Korea, Republic of	Pfizer Investigational Site	Daegu
Korea, Republic of	Pfizer Investigational Site	Daegu
Korea, Republic of	Pfizer Investigational Site	Goyang-si	Gyeonggi-do
Korea, Republic of	Pfizer Investigational Site	Hwasun-gun	Jeollanam-do
Korea, Republic of	Pfizer Investigational Site	Incheon
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Malaysia	Pfizer Investigational Site	Kuala Lumpur
Malaysia	Pfizer Investigational Site	Lembah Pantai	Kuala Lumpur
Malaysia	Pfizer Investigational Site	Subang Jaya	Selangor
Philippines	Pfizer Investigational Site	Cebu City	Cebu
Philippines	Pfizer Investigational Site	Cebu City
Philippines	Pfizer Investigational Site	Davao City
Philippines	Pfizer Investigational Site	Manila
Philippines	Pfizer Investigational Site	Manila
Philippines	Pfizer Investigational Site	Quezon City
Philippines	Pfizer Investigational Site	Quezon City
Philippines	Pfizer Investigational Site	Quezon City
Poland	Pfizer Investigational Site	Warszawa
Poland	Pfizer Investigational Site	Warszawa
Russian Federation	Pfizer Investigational Site	Chelyabinsk
Russian Federation	Pfizer Investigational Site	Pyatigorsk
Russian Federation	Pfizer Investigational Site	St.Petersburg
Singapore	Pfizer Investigational Site	Singapore
Singapore	Pfizer Investigational Site	Singapore
South Africa	Pfizer Investigational Site	Parktown
Spain	Pfizer Investigational Site	El Palmar	Murcia
Spain	Pfizer Investigational Site	Palma de Mallorca	Illes Balears
Spain	Pfizer Investigational Site	Sabadell	Barcelona
Spain	Pfizer Investigational Site	Santander	Cantabria
Spain	Pfizer Investigational Site	Sevilla
Sweden	Pfizer Investigational Site	Linkoping
Taiwan	Pfizer Investigational Site	Changhua
Taiwan	Pfizer Investigational Site	Kaohsiung
Taiwan	Pfizer Investigational Site	Kaohsiung
Taiwan	Pfizer Investigational Site	Kwei-Shan	Taoyuan
Taiwan	Pfizer Investigational Site	Pu-Tz City	Chai-Yi
Taiwan	Pfizer Investigational Site	Taichung
Taiwan	Pfizer Investigational Site	Taichung City
Taiwan	Pfizer Investigational Site	Tainan
Taiwan	Pfizer Investigational Site	Tainan
Taiwan	Pfizer Investigational Site	Taipei
Taiwan	Pfizer Investigational Site	Taipei
Thailand	Pfizer Investigational Site	Amphoe Mueang	Chiang Mai
Thailand	Pfizer Investigational Site	Bangkok Noi	Bangkok
Thailand	Pfizer Investigational Site	Ptumwan	Bangkok
Turkey	Pfizer Investigational Site	Ankara
Turkey	Pfizer Investigational Site	Istanbul
United Kingdom	Pfizer Investigational Site	Cambridge	Cambridgeshire
United Kingdom	Pfizer Investigational Site	London
United Kingdom	Pfizer Investigational Site	London
United States	Pfizer Investigational Site	Bronx	New York
United States	Pfizer Investigational Site	Chattanooga	Tennessee
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Crestview Hills	Kentucky
United States	Pfizer Investigational Site	Fairfield	Ohio
United States	Pfizer Investigational Site	Fountain Valley	California
United States	Pfizer Investigational Site	Franklin	Tennessee
United States	Pfizer Investigational Site	Gallatin	Tennessee
United States	Pfizer Investigational Site	Hamilton	Ohio
United States	Pfizer Investigational Site	Hermitage	Tennessee
United States	Pfizer Investigational Site	Hixson	Tennessee
United States	Pfizer Investigational Site	Iowa City	Iowa
United States	Pfizer Investigational Site	La Jolla	California
United States	Pfizer Investigational Site	La Jolla	California
United States	Pfizer Investigational Site	Lebanon	Tennessee
United States	Pfizer Investigational Site	Mechanicsville	Virginia
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Midlothian	Virginia
United States	Pfizer Investigational Site	Murfreesboro	Tennessee
United States	Pfizer Investigational Site	Nashville	Tennessee
United States	Pfizer Investigational Site	Nashville	Tennessee
United States	Pfizer Investigational Site	Nashville	Tennessee
United States	Pfizer Investigational Site	Nashville	Tennessee
United States	Pfizer Investigational Site	Orange	California
United States	Pfizer Investigational Site	Richmond	Virginia
United States	Pfizer Investigational Site	Richmond	Virginia
United States	Pfizer Investigational Site	Ringgold	Georgia
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	Smyrna	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  China,  France,  Germany,  Hong Kong,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Philippines,  Poland,  Russian Federation,  Singapore,  South Africa,  Spain,  Sweden,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150	No
Secondary	Progression-Free Survival (PFS)	The period from randomization until disease progression or death.	Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150	No
Secondary	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])	Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150	No
Secondary	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.	Day 1 of each cycle	No

External Links

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