Study Of Sunitinib Malate Versus Sorafenib In Patients With Inoperable Liver Cancer
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|ClinicalTrials.gov Identifier: NCT00699374|
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : June 18, 2008
Results First Posted : January 14, 2013
Last Update Posted : January 14, 2013
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|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Hepatocellular||Drug: sunitinib malate Drug: sorafenib||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1075 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multinational, Randomized, Open-Label, Phase 3 Study Of Sunitinib Malate Versus Sorafenib In Patients With Advanced Hepatocellular Carcinoma|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
Experimental: Arm A
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 Name: Sutent®
Active Comparator: Arm B
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 Name: Nexavar®
- 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.
- 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.
- 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])
- 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00699374
|Study Director:||Pfizer CT.gov Call Center||Pfizer|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Other Study ID Numbers:||
|First Posted:||June 18, 2008 Key Record Dates|
|Results First Posted:||January 14, 2013|
|Last Update Posted:||January 14, 2013|
|Last Verified:||December 2012|
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Protein Kinase Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Modulating Agents
Physiological Effects of Drugs