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Trial record 1 of 1 for:    NCT00692770
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Sorafenib as Adjuvant Treatment in the Prevention Of Recurrence of Hepatocellular Carcinoma (STORM) (STORM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00692770
First Posted: June 6, 2008
Last Update Posted: October 16, 2017
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):
Bayer
Results First Submitted: November 24, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Carcinoma, Hepatocellular
Interventions: Drug: Nexavar (Sorafenib, BAY43-9006)
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participant recruitment period was between 15 August 2008 to 12 November 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 1602 participants who were screened for inclusion in the study, 1114 were enrolled, and 1107 received treatment.

Reporting Groups
  Description
Sorafenib (Nexavar, BAY43-9006) Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
Placebo Participants received 2 tablets of placebo orally twice daily (BID)

Participant Flow:   Overall Study
    Sorafenib (Nexavar, BAY43-9006)   Placebo
STARTED   556   558 
Participants Received Treatment   553   554 
COMPLETED   0   0 
NOT COMPLETED   556   558 
Protocol Violation                2                7 
Withdrawal by Subject                97                36 
Adverse Event                136                41 
Death                10                5 
Lost to Follow-up                7                3 
Non-compliant with study medication                11                5 
Progression by clinical judgment                2                3 
Physician decision not protocol driven                10                14 
Disease progression, recurrence/relapse                170                279 
Protocol driven decision point                3                7 
Completed all planned assessments                79                101 
Radiological and clinical progression                8                8 
Clinical endpoint reached                16                43 
Study terminated by sponsor                2                2 
Randomized but not treated                3                4 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Sorafenib (Nexavar, BAY43-9006) Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
Placebo Participants received 2 tablets of placebo orally twice daily (BID)
Total Total of all reporting groups

Baseline Measures
   Sorafenib (Nexavar, BAY43-9006)   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 556   558   1114 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.1  (11.7)   58.7  (12.2)   58.4  (12.0) 
Age, Customized 
[Units: Participants]
     
<18 years   0   0   0 
Between 18 and 65 years   383   361   744 
>=65 years   173   197   370 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      105  18.9%      97  17.4%      202  18.1% 
Male      451  81.1%      461  82.6%      912  81.9% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Recurrence Free Survival (RFS) by Independent Assessment   [ Time Frame: From randomization up to 4 years or until disease recurrence whichever came first ]

2.  Secondary:   Time to Recurrence (TTR) by Independent Assessment   [ Time Frame: From randomization up to 4 years or until disease recurrence whichever came first ]

3.  Secondary:   Overall Survival (OS)   [ Time Frame: From randomization of the first subject until 4 years later. ]

4.  Other Pre-specified:   Patient Reported Outcomes: Euroqol-5 Dimensions (EQ-5D) - Index Score   [ Time Frame: Cycle (C) Day (D)1, C2D1, C3D1 and subsequent cycles up to C18, end of intervention visit ]

5.  Other Pre-specified:   Patient Reported Outcomes: Euroqol-5 Dimensions (EQ-5D) - Visual Analogue Scale (VAS) Score   [ Time Frame: Cycle (C) Day (D)1, C2D1, C3D1 and subsequent cycles up to C18, end of intervention visit ]

6.  Other Pre-specified:   Patient Reported Outcomes: Functional Assessment of Cancer Therapy (FACT)- Hepatobiliary Subscale (HEP) Score   [ Time Frame: Cycle (C) Day (D)1, C2D1, C3D1 and subsequent cycles up to C18, end of intervention visit ]

7.  Other Pre-specified:   Patient Reported Outcomes: Functional Assessment of Cancer Therapy (FACT)- General (G) Total Score   [ Time Frame: Cycle (C) Day (D)1, C2D1, C3D1 and subsequent cycles up to C18, end of intervention visit ]

8.  Other Pre-specified:   The Correlation Between Plasma Biomarker Levels at Baseline With RFS to Determine Prognostic Value of Biomarkers - ANG-2   [ Time Frame: At Baseline ]

9.  Other Pre-specified:   The Correlation Between Plasma Biomarker Levels at Baseline With RFS to Determine Prognostic Value of Biomarkers - AFP   [ Time Frame: At Baseline ]

10.  Other Pre-specified:   The Correlation Between Plasma Biomarker Levels at Baseline With RFS to Determine Prognostic Value of Biomarkers - MET   [ Time Frame: At Baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com


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

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00692770     History of Changes
Other Study ID Numbers: 12414
2008-001087-36 ( EudraCT Number )
First Submitted: June 5, 2008
First Posted: June 6, 2008
Results First Submitted: November 24, 2014
Results First Posted: December 1, 2014
Last Update Posted: October 16, 2017