Trial record 1 of 1 for:    NCT00901901
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Nexavar-Tarceva Combination Therapy for First Line Treatment of Patients Diagnosed With Hepatocellular Carcinoma (SEARCH)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00901901
First received: May 13, 2009
Last updated: July 9, 2014
Last verified: July 2014
Results First Received: April 10, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Carcinoma, Hepatocellular
Interventions: Drug: Sorafenib (Nexavar, BAY43-9006)
Drug: Sorafenib (Nexavar, BAY43-9006) + Erlotinib, Tarceva

  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
The study was conducted at 128 study centers in 26 countries in North America, South America, Europe, Africa, and Asia.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 962 screened participants, 242 were screen failures and were excluded from participated in the study. A total of 720 participants were randomized to study arms: 358 participants in the sorafenib + placebo group and 362 participants in the sorafenib + erlotinib group.

Reporting Groups
  Description
Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva) Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
Sorafenib (Nexavar, BAY43-9006) + Placebo Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)

Participant Flow for 2 periods

Period 1:   Treatment Period
    Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva)     Sorafenib (Nexavar, BAY43-9006) + Placebo  
STARTED     362     358  
Participants Received Treatment     362     355  
COMPLETED     205 [1]   190 [2]
NOT COMPLETED     157     168  
Adverse Event                 117                 123  
Withdrawal by Subject                 26                 24  
Physician Decision                 2                 2  
Lost to Follow-up                 3                 5  
Noncompliance with study medication                 4                 1  
Protocol Violation                 4                 9  
Missing                 1                 1  
Never treated                 0                 3  
[1] 19 of these participants are ongoing
[2] 17 of these participants are ongoing

Period 2:   Follow-up Period
    Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva)     Sorafenib (Nexavar, BAY43-9006) + Placebo  
STARTED     322     324  
COMPLETED     76 [1]   65 [1]
NOT COMPLETED     246     259  
Death                 181                 207  
Protocol driven decision point                 47                 35  
Withdrawal by Subject                 6                 9  
Lost to Follow-up                 12                 8  
[1] These participants are ongoing.



  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) + Erlotinib (Tarceva) Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
Sorafenib (Nexavar, BAY43-9006) + Placebo Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
Total Total of all reporting groups

Baseline Measures
    Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva)     Sorafenib (Nexavar, BAY43-9006) + Placebo     Total  
Number of Participants  
[units: participants]
  362     358     720  
Age  
[units: Years]
Mean ± Standard Deviation
  60.3  ± 11.8     59.5  ± 13.0     59.9  ± 12.4  
Gender  
[units: Participants]
     
Female     67     72     139  
Male     295     286     581  
Smoking status  
[units: Participants]
     
non-smoker     112     107     219  
former smoker     132     128     260  
current smoker     118     123     241  
ECOG stratification group [1]
[units: Participants]
     
0     222     216     438  
1     140     142     282  
Macroscopic vascular invasion  
[units: Participants]
     
Yes     138     153     291  
No     224     205     429  
Extrahepatic spread  
[units: Participants]
     
Yes     205     219     424  
No     157     139     296  
[1] Eastern Cooperative Oncology Group (ECOG) grade 0 = fully active; grade 1 = restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature.



  Outcome Measures
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1.  Primary:   Overall Survival   [ Time Frame: From randomization of the first patient until 34 months or date of death of any cause whichever came first ]

2.  Secondary:   Time to Radiological Tumor Progression (TTP)   [ Time Frame: From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks ]

3.  Secondary:   Disease Control   [ Time Frame: From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks ]

4.  Secondary:   Health-related Quality of Life and Utility Values as Measured by EQ-5D - Index   [ Time Frame: The EQ-5D was administered at the beginning of the visit prior to seeing the investigator. Questionnaires were to be completed every 6 weeks (Day 1 of each cycle) for subsequent cycles and at the end of treatment visit. ]

5.  Secondary:   Health-related Quality of Life and Utility Values as Measured by EQ-5D - VAS   [ Time Frame: The EQ-5D VAS was administered at the beginning of the visit prior to seeing the investigator. Questionnaires were to be completed every 6 weeks (Day 1 of each cycle) for subsequent cycles and at the end of treatment visit. ]

6.  Other Pre-specified:   Duration of Response   [ Time Frame: From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks ]

7.  Other Pre-specified:   Time to Response   [ Time Frame: From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks ]

8.  Other Pre-specified:   Tumor Response   [ Time Frame: From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks ]


  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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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


No publications provided


Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00901901     History of Changes
Other Study ID Numbers: 12917, 2008-006021-14
Study First Received: May 13, 2009
Results First Received: April 10, 2013
Last Updated: July 9, 2014
Health Authority: United States: Food and Drug Administration
Austrialia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: National Health Surveillance Agency
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
China: Food and Drug Administration
Colombia: National Institutes of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ethics Committee
Hong Kong: Department of Health
Israel: Ethics Commission
Italy: Ethics Committee
Japan: Pharmaceuticals and Medical Devices Agency
Peru: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
Singapore: Health Sciences Authority
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
Taiwan: Center for Drug Evaluation
United Kingdom: Medicines and Healthcare Products Regulatory Agency