Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003674

Trial Description

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Title

An Open-label, Randomized Phase 3 Study of the Efficacy and Tolerability of Linifanib (ABT-869) Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma (HCC)

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The primary objective of this study is to assess the overall survival (OS) of oral linifanib
given as monotherapy once daily (QD) compared to sorafenib given twice daily (BID) per
standard of care in subjects with advanced or metastatic HCC.

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Brief Summary in Scientific Language

The IDMC recommended discontinuation of the study, and, the protocol was amended to end
study treatment.

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Organizational Data

  •   DRKS00003674
  •   2012/05/08
  •   2009/10/14
  •   no
  •   [---]*
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Secondary IDs

  •   2009-013435-38 
  •   NCT01009593  (ClinicalTrials.gov)
  •   M10-963  (Abbott)
  •   2009-013435-38 
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Health Condition or Problem studied

  •   Hepatocellular Carcinoma Non-resectable
  •   Hepatocellular Carcinoma Recurrent
  •   Carcinoma, Hepatocellular
  •   Liver Diseases
  •   Neoplasms by Histologic Type
  •   Digestive System Neoplasms
  •   Carcinoma
  •   Liver Neoplasms
  •   Neoplasms
  •   Neoplasms by Site
  •   Digestive System Diseases
  •   Adenocarcinoma
  •   Neoplasms, Glandular and Epithelial
  •   C22.0 -  Malignant neoplasm: Liver cell carcinoma
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Interventions/Observational Groups

  •   Drug: ABT-869
  •   Drug: Sorafenib
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

- Overall Survival; time frame: From randomization until patient death; assessed monthly

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Secondary Outcome

- Time To Progression (TTP); time frame: From randomization until patient progression; assessed every 6 weeks
- Overall Response Rate (ORR); time frame: Assessed Every 6 weeks

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Countries of Recruitment

  •   United States
  •   Argentina
  •   Australia
  •   Austria
  •   Belgium
  •   Canada
  •   Chile
  •   China
  •   Czech Republic
  •   Denmark
  •   Egypt
  •   France
  •   Germany
  •   Greece
  •   Hong Kong
  •   Italy
  •   Japan
  •   Korea, Republic of
  •   Malaysia
  •   Mexico
  •   Netherlands
  •   New Zealand
  •   Norway
  •   Puerto Rico
  •   Romania
  •   Russian Federation
  •   Singapore
  •   Spain
  •   Taiwan, Province of China
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Locations of Recruitment

  •  
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Recruitment

  •   [---]*
  •   2010/01/31
  •   1100
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Inclusion Criteria

- Histologic or cytologic diagnosis with unresectable or metastatic HCC

- Child Pugh Class A

- ECOG performance status 0-1

- Adequate hematologic, hepatic, and renal function

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Exclusion Criteria

Exclusion Criteria

- Prior systemic (administered intravenously or orally rather than locoregionally)
treatment for HCC

- Prior local therapy (including liver-directed therapy) within 4 weeks from entry

- Untreated brain or meningeal metastases

- Current treatment on another clinical trial

- Pregnancy or breastfeeding

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Addresses

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    • Abbott
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    • Abbott
    • Justin Ricker, MD 
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    •   [---]*
    •   [---]*
    •   [---]*
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    • Abbott
    • Justin Ricker, MD 
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting stopped after recruiting started
  •   2012/07/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   7
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.