BAY43-9006 - Phase II Study in Non-Small Cell Lung Carcinoma (NSCLC)

This study has been completed.
Sponsor:
Collaborator:
Onyx Pharmaceuticals
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00101413
First received: January 10, 2005
Last updated: September 29, 2013
Last verified: September 2013
Results First Received: April 17, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Cancer
Carcinoma, Non-Small Cell Lung
Intervention: Drug: Sorafenib (Nexavar, BAY43-9006)

  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
Study conducted in Germany and USA (1 center each) from Apr 2004 to Jun 2005. Recruitment in 2 phases: Interim analysis (IA) to be performed after treatment of 29 patients; final analysis planned after additional 21 patients. Final analysis data cut-off date 30 Jun 2005; safety data collected for the 4 ongoing subjects until 11 Apr 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
52 of 54 enrolled patients started treatment. The analysis population consisted of 52 subjects for the intent to treat (ITT) and safety analyses and 51 subjects in the evaluable subject analysis (1 had lung metastases from pancreatic cancer).

Reporting Groups
  Description
Sorafenib Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles

Participant Flow:   Overall Study
    Sorafenib  
STARTED     52  
COMPLETED     52 [1]
NOT COMPLETED     0  
[1] Safety data collected for 4 subjects after 30 Jun 2005 until 11 Apr 2008.



  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 Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles

Baseline Measures
    Sorafenib  
Number of Participants  
[units: participants]
  52  
Age  
[units: years]
Median ( Full Range )
  62  
  ( 26 to 85 )  
Age, Customized  
[units: participants]
 
>=65 years     21  
< 65 years     31  
Gender  
[units: participants]
 
Female     18  
Male     34  
Histology [1]
[units: participants]
 
Adenocarcinoma NSCLC     28  
Large cell carcinoma     4  
Squamous cell (epidermoid) carcinoma     16  
Undifferentiated carcinoma     4  
[1] Measurable, histologically or cytologically documented stage IV non-small cell lung cancer (NSCLC). Subjects must have had disease progression at the time of study entry and have been treated with at least 1 but no more than 2 prior systemic agents or regimens (including gefitinib).



  Outcome Measures
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1.  Primary:   Anti-cancer Activity (eg, Percentage of Patients With Confirmed Complete Responses (CR) and Partial Responses (PR) Per RECIST (Response Evaluation Criteria in Solid Tumors) Criteria in Patients With Stage IV Non-small Cell Lung Carcinoma (NSCLC)   [ Time Frame: First patient first treatment until date for last data collection for efficacy for a study period up to 62 weeks. Tumor assessed per RECIST at baseline (BL), every 8 weeks during treatment and at end of treatment. ]

2.  Secondary:   Duration of Stable Disease   [ Time Frame: First patient first treatment until date for last data collection for efficacy for a study period up to 62 weeks. Tumor assessed per RECIST at baseline (BL), every 8 weeks during treatment and at end of treatment. ]

3.  Secondary:   Overall Survival   [ Time Frame: First patient first treatment until date for last data collection for efficacy for a study period up to 62 weeks. ]

4.  Secondary:   Percentage of Subjects With Stable Disease (SD)   [ Time Frame: First patient first treatment until date for last data collection for efficacy for a study period up to 62 weeks. Tumor assessed per RECIST at baseline (BL), every 8 weeks during treatment and at end of treatment. ]

5.  Secondary:   Change From Baseline of Health-Related Quality of Life (HRQOL) Score Assessed at Cycle 2, Cycle 4, and End of Treatment (EOT)   [ Time Frame: From first patient first treatment until date of last efficacy data collection (study period up to 62 weeks). HRQoL assessed at baseline (BL), end of treatment Cycles 2 and 4, and at end of treatment ]


  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
Due to rapid enrollment, no IA (interim analysis) was performed.


  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 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.
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:

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00101413     History of Changes
Other Study ID Numbers: 100557
Study First Received: January 10, 2005
Results First Received: April 17, 2009
Last Updated: September 29, 2013
Health Authority: United States: Food and Drug Administration