Sorafenib Dose Escalation in Renal Cell Carcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00618982
First received: February 8, 2008
Last updated: September 11, 2013
Last verified: September 2013
Results First Received: April 30, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Carcinoma, Renal Cell
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
Subjects were enrolled from 04 Feb to 05 Nov 2008 at 19 centers in 5 countries (Germany, France, United Kingdom, Italy and Poland).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 89 subjects enrolled, 83 were treated with the study drug. Safety population = 83 subjects who took at least one dose of study drug and had any data after baseline. Intent to treat population = 67 subjects treated with the study drug who had at least one efficacy evaluation after baseline.

Reporting Groups
  Description
Sorafenib (Nexavar, BAY43-9006) Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.

Participant Flow:   Overall Study
    Sorafenib (Nexavar, BAY43-9006)  
STARTED     83  
COMPLETED     33  
NOT COMPLETED     50  
Adverse Event                 23  
Withdrawal by Subject                 1  
Protocol Violation                 1  
ongoing, still treated with study med.                 25  



  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) Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.

Baseline Measures
    Sorafenib (Nexavar, BAY43-9006)  
Number of Participants  
[units: participants]
  83  
Age  
[units: years]
Median ( Full Range )
  61  
  ( 33 to 80 )  
Gender  
[units: participants]
 
Female     29  
Male     54  
ECOG (Eastern Cooperative Oncology Group) Performance Status [1]
[units: participants]
 
0     49  
1     34  
Stage at study entry [2]
[units: participants]
 
Stage III     1  
Stage IV     82  
[1] Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale that measures how cancer affects the daily life of a patient on an ordinal scale from grade 0 (best) to grade 5 (worst). Status 0 = fully active; Status 1 = restricted strenuous activity, ambulatory and able to carry out work of a light or sedentary nature
[2] Categorized information on tumor size, lymph node involvement and metastases. Stages I-IV. The higher the stage, the more advanced cancer.



  Outcome Measures
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1.  Primary:   Best Response - mITT (Modified Intent-to-treat) Population   [ Time Frame: Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months. ]

2.  Primary:   Tumor Response - ITT (Intent to Treat) Population   [ Time Frame: Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months. ]

3.  Secondary:   Pharmacokinetics (PK) Analysis – Area Under the Drug Concentration-time Curve From Time Zero to 10 Hours Postdose (AUC(0-10),ss)   [ Time Frame: Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8 and 10 hours post-dose. ]

4.  Secondary:   Pharmacokinetics (PK) Analysis – Area Under the Drug Concentration-time Curve From Time Zero to 12 Hours Postdose (AUC(0-12),ss)   [ Time Frame: Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8, 10 and 12 hours post-dose. ]

5.  Secondary:   Pharmacokinetics (PK) Analysis – Maximum Observed Concentration in Plasma (Cmax)   [ Time Frame: Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8, 10 and 12 hours post-dose. ]

6.  Secondary:   Pharmacokinetics (PK) Analysis – Time to Maximum Concentration (Tmax)   [ Time Frame: Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8, 10 and 12 hours post-dose. ]

7.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months. ]

8.  Secondary:   Time to Progression (TTP)   [ Time Frame: Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months. ]

9.  Other Pre-specified:   Tumor Response - mITT Population   [ Time Frame: Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months. ]

10.  Other Pre-specified:   Disease Control - mITT Population   [ Time Frame: Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months. ]


  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
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  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-trials-contact@bayerhealthcare.com


No publications provided


Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00618982     History of Changes
Other Study ID Numbers: 12913, 2007-004875-21
Study First Received: February 8, 2008
Results First Received: April 30, 2010
Last Updated: September 11, 2013
Health Authority: France: Direction Générale de la Santé
Germany: Federal Institute for Drugs and Medical Devices
Italy: Fondazione IRCCS "Istituto Nazionale dei Tumori"
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
United Kingdom: Medicines and Healthcare Products Regulatory Agency