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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Drug: sunitinib malate Drug: sorafenib Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1075 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: Nexavar®


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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])

  3. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00699374    
Other Study ID Numbers: A6181170
First Posted: June 18, 2008    Key Record Dates
Results First Posted: January 14, 2013
Last Update Posted: January 14, 2013
Last Verified: December 2012
Keywords provided by Pfizer:
sunitinib
phase 3
randomized
hepatocellular
liver
Additional relevant MeSH terms:
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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
 Sorafenib
Sunitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors