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

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00699374
First Posted: June 18, 2008
Last Update Posted: January 14, 2013
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.
Information provided by (Responsible Party):
Pfizer
June 16, 2008
June 18, 2008
December 7, 2012
January 14, 2013
January 14, 2013
July 2008
December 2011   (Final data collection date for primary outcome measure)
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.
Overall Survival [ Time Frame: From screening/baseline to patient death ]
Complete list of historical versions of study NCT00699374 on ClinicalTrials.gov Archive Site
  • 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.
  • Progression Free Survival [ Time Frame: From Screening/baseline until patient progression or death ]
  • Time to Tumor Progression [ Time Frame: From screening/baseline until patient progression ]
  • Safety (adverse events and laboratory abnormalities) [ Time Frame: From screening/baseline to end of study treatment ]
  • Health Status [ Time Frame: From baseline to end of study treatment ]
Not Provided
Not Provided
 
Study Of Sunitinib Malate Versus Sorafenib In Patients With Inoperable Liver Cancer
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Carcinoma, Hepatocellular
  • 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®
  • 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®
  • Experimental: Arm A
    sunitinib arm
    Intervention: Drug: sunitinib malate
  • Active Comparator: Arm B
    sorafenib arm
    Intervention: Drug: sorafenib

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1075
December 2011
December 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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,   United States
Czech Republic
 
NCT00699374
A6181170
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP