A Phase II Uncontrolled Study of BAY73-4506 in Previously Untreated Patients With Metastatic or Unresectable RCC

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00664326
First received: April 17, 2008
Last updated: August 6, 2014
Last verified: August 2014
Results First Received: October 28, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Carcinoma, Renal Cell
Intervention: Drug: Regorafenib (Stivarga, BAY73-4506)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Male or female untreated participants, who were at least 18 years of age, with metastatic and/or unresectable, measurable predominantly clear cell renal cell cancer (RCC) histologically or cytologically documented could participate in this study at 18 centers in 6 countries.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 64 enrolled participants, 49 received study medication, and 15 were screen failures due to protocol violation (12 participants), withdrawal of consent (1 participant), adverse event (2 participants).

Reporting Groups
  Description
Regorafenib (Stivarga, BAY73-4506) Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle

Participant Flow:   Overall Study
    Regorafenib (Stivarga, BAY73-4506)  
STARTED     49  
COMPLETED     25  
NOT COMPLETED     24  
Adverse Event                 13  
Noncompliance with study medication                 3  
Withdrawal by Subject                 1  
Physician Decision                 1  
ongoing with treatment                 6  



  Baseline Characteristics
  Hide Baseline Characteristics

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
Regorafenib (Stivarga, BAY73-4506) Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle

Baseline Measures
    Regorafenib (Stivarga, BAY73-4506)  
Number of Participants  
[units: participants]
  49  
Age  
[units: Years]
Median ( Full Range )
  62.0  
  ( 40 to 76 )  
Gender  
[units: Participants]
 
Female     22  
Male     27  
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) [1]
[units: Participants]
 
0     30  
1     19  
Overall Motzer Score [2]
[units: Participants]
 
Low     24  
Intermediate     25  
[1] The ECOG PS ranged from Grades 0 to 5 (death). Grade 0 (fully active, able to carry on all pre-diseases performance without restriction) and Grade 1 (restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature) were inclusion criteria.
[2] The Motzer score (high/poor risk, intermediate risk, low risk) is based on the number of the following poor prognostic features a participant possessed: ECOG >2, serum lactate dehydrogenase concentration > 1.5 times the upper limit of normal, hemoglobin < lower limit of normal, corrected calcium concentration > 10 mg/dl, and absence of prior nephrectomy. Participants who had none of these features = low risk; participants with 1 or 2 of these features = intermediate risk; participants with 3 or more of these features = high/poor risk and were excluded from participating in the study.



  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Objective Tumor Response   [ Time Frame: From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks ]

Measure Type Primary
Measure Title Objective Tumor Response
Measure Description Objective tumor response of a participant was defined as the best tumor response (confirmed Complete Response [CR, tumor disappears] or Partial Response [PR, sum of lesion sizes decreased at least 30% from baseline]) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) committee.
Time Frame From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks  
Safety Issue No  

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.
Evaluable for response (Primary analysis population)

Reporting Groups
  Description
Regorafenib (Stivarga, BAY73-4506) Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle

Measured Values
    Regorafenib (Stivarga, BAY73-4506)  
Number of Participants Analyzed  
[units: participants]
  48  
Objective Tumor Response  
[units: Percentage of participants]
  31.3  

No statistical analysis provided for Objective Tumor Response



2.  Primary:   Tumor Response   [ Time Frame: From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks ]

Measure Type Primary
Measure Title Tumor Response
Measure Description Tumor response of a participant was defined as the best tumor response (confirmed Complete Response [CR, tumor disappears], Partial Response [PR, sum of lesion sizes decreased at least 30% from baseline], Stable Disease [SD, steady state of disease], or Progressive Disease [PD, sum of lesion sizes increased at least 20% from smallest sum on study or new lesions]) observed during trial period assessed according to the RECIST committee.
Time Frame From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks  
Safety Issue No  

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.
Evaluable for response (Primary analysis population)

Reporting Groups
  Description
Regorafenib (Stivarga, BAY73-4506) Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle

Measured Values
    Regorafenib (Stivarga, BAY73-4506)  
Number of Participants Analyzed  
[units: participants]
  48  
Tumor Response  
[units: Percentage of participants]
 
Complete Response (CR)     0.0  
Partial Response (PR)     31.3  
Stable Disease (SD)     50.0  
Progressive Disease (PD)     10.4  
Not Assessable     8.3  

No statistical analysis provided for Tumor Response



3.  Secondary:   Disease Control   [ Time Frame: From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks ]

Measure Type Secondary
Measure Title Disease Control
Measure Description Disease control was defined as the percentage of participants who had a best response rating of CR (tumor disappears), PR (sum of lesion sizes decreased at least 30% from baseline), or SD (steady state of disease) that was maintained for at least 28 days from the first demonstration of that rating.
Time Frame From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks  
Safety Issue No  

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.
Evaluable for response (Primary analysis population)

Reporting Groups
  Description
Regorafenib (Stivarga, BAY73-4506) Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle

Measured Values
    Regorafenib (Stivarga, BAY73-4506)  
Number of Participants Analyzed  
[units: participants]
  48  
Disease Control  
[units: Percentage of participants]
  62.5  

No statistical analysis provided for Disease Control



4.  Secondary:   Overall Survival   [ Time Frame: From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). ]

Measure Type Secondary
Measure Title Overall Survival
Measure Description Overall survival (OS) was calculated as the time from the first date of receiving study medication to death, due to any cause. Participants alive at the time of analysis were censored at their last date of follow-up.
Time Frame From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009).  
Safety Issue No  

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.
intention-to-treat (ITT)

Reporting Groups
  Description
Regorafenib (Stivarga, BAY73-4506) Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle

Measured Values
    Regorafenib (Stivarga, BAY73-4506)  
Number of Participants Analyzed  
[units: participants]
  49  
Overall Survival  
[units: Days]
Median ( 95% Confidence Interval )
  NA  
  ( 285 to NA ) [1]
[1] Not estimable due to censored data.

No statistical analysis provided for Overall Survival



5.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks ]

Measure Type Secondary
Measure Title Progression-free Survival (PFS)
Measure Description PFS was calculated as time from first date of receiving study drug until date of first observed disease progression (PD) (radiological or clinical, whichever was earlier) or death due to any cause, if death occurred before PD was documented. The actual date of tumor assessments (i.e., date on which radiological procedure was performed, rather than scheduled date) was used for this calculation to determine both the event date and censoring date. Patients without PD or death at time of analysis were censored at last date of tumor evaluation.
Time Frame From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks  
Safety Issue No  

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.
intention-to-treat (ITT)

Reporting Groups
  Description
Regorafenib (Stivarga, BAY73-4506) Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle

Measured Values
    Regorafenib (Stivarga, BAY73-4506)  
Number of Participants Analyzed  
[units: participants]
  49  
Progression-free Survival (PFS)  
[units: Days]
Median ( 95% Confidence Interval )
  251  
  ( 160 to NA ) [1]
[1] Not estimable due to censored data.

No statistical analysis provided for Progression-free Survival (PFS)



6.  Secondary:   Time to Progression (TTP)   [ Time Frame: From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks ]

Measure Type Secondary
Measure Title Time to Progression (TTP)
Measure Description TTP was calculated as time from first date of receiving study drug until date of first documented disease progression (PD) (radiological or clinical, whichever was earlier). The actual date of tumor assessments (i.e., date on which radiological procedure was performed, rather than the scheduled date) was used for this calculation to determine both the event date and censoring date. Patients without PD at time of analysis were censored at last date of tumor evaluation.
Time Frame From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks  
Safety Issue No  

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.
intention-to-treat (ITT)

Reporting Groups
  Description
Regorafenib (Stivarga, BAY73-4506) Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle

Measured Values
    Regorafenib (Stivarga, BAY73-4506)  
Number of Participants Analyzed  
[units: participants]
  49  
Time to Progression (TTP)  
[units: Days]
Median ( 95% Confidence Interval )
  251  
  ( 167 to NA ) [1]
[1] Not estimable due to censored data.

No statistical analysis provided for Time to Progression (TTP)



7.  Secondary:   Duration of Response   [ Time Frame: From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks ]

Measure Type Secondary
Measure Title Duration of Response
Measure Description Duration of response was defined as the time from the first documented objective response of PR or CR, whichever was earlier, to disease progression or death (if death occurred before progression was documented). Duration of response for subjects who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment.
Time Frame From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks  
Safety Issue No  

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.
Only subjects from ITT population with a response of CR or PR were included in this evaluation.

Reporting Groups
  Description
Regorafenib (Stivarga, BAY73-4506) Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle

Measured Values
    Regorafenib (Stivarga, BAY73-4506)  
Number of Participants Analyzed  
[units: participants]
  15  
Duration of Response  
[units: Days]
Median ( 95% Confidence Interval )
  NA  
  ( 140 to NA ) [1]
[1] Not estimable due to censored data.

No statistical analysis provided for Duration of Response



8.  Secondary:   Duration of Stable Disease (SD)   [ Time Frame: From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks ]

Measure Type Secondary
Measure Title Duration of Stable Disease (SD)
Measure Description Duration of SD was calculated as the time from the first date of receiving study drug until the date of documented PD or the last observation if the subject did not progress. Subjects without disease progression at the time of analysis were censored at the last date of tumor evaluation.
Time Frame From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks  
Safety Issue No  

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.
Subjects from ITT population who achieved objective response of CR or PR were excluded from this evaluation.

Reporting Groups
  Description
Regorafenib (Stivarga, BAY73-4506) Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle

Measured Values
    Regorafenib (Stivarga, BAY73-4506)  
Number of Participants Analyzed  
[units: participants]
  29  
Duration of Stable Disease (SD)  
[units: Days]
Median ( 95% Confidence Interval )
  172  
  ( 107 to NA ) [1]
[1] Not estimable due to censored data.

No statistical analysis provided for Duration of Stable Disease (SD)



9.  Other Pre-specified:   Objective Tumor Response (Update)   [ Time Frame: From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks ]

Measure Type Other Pre-specified
Measure Title Objective Tumor Response (Update)
Measure Description Objective tumor response of a participant was defined as the best tumor response (confirmed Complete Response [CR, tumor disappears] or Partial Response [PR, sum of lesion sizes decreased at least 30% from baseline]) observed during trial period assessed according to the RECIST committee.
Time Frame From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks  
Safety Issue No  

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.
Evaluable for response (Primary analysis population)

Reporting Groups
  Description
Regorafenib (Stivarga, BAY73-4506) Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle

Measured Values
    Regorafenib (Stivarga, BAY73-4506)  
Number of Participants Analyzed  
[units: participants]
  48  
Objective Tumor Response (Update)  
[units: Percentage of participants]
  39.6  

No statistical analysis provided for Objective Tumor Response (Update)



10.  Other Pre-specified:   Tumor Response (Update)   [ Time Frame: From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks ]

Measure Type Other Pre-specified
Measure Title Tumor Response (Update)
Measure Description Tumor response of a participant was defined as the best tumor response (confirmed Complete Response [CR, tumor disappears], Partial Response [PR, sum of lesion sizes decreased at least 30% from baseline], Stable Disease [SD, steady state of disease], or Progressive Disease [PD, sum of lesion sizes increased at least 20% from smallest sum on study or new lesions]) observed during trial period assessed according to the RECIST committee.
Time Frame From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks  
Safety Issue No  

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.
Evaluable for response (Primary analysis population)

Reporting Groups
  Description
Regorafenib (Stivarga, BAY73-4506) Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle

Measured Values
    Regorafenib (Stivarga, BAY73-4506)  
Number of Participants Analyzed  
[units: participants]
  48  
Tumor Response (Update)  
[units: Percentage of participants]
 
Complete Response (CR)     0.0  
Partial Response (PR)     39.6  
Stable Disease (SD)     41.7  
Progressive Disease (PD)     10.4  
Not Assessable     8.3  

No statistical analysis provided for Tumor Response (Update)



11.  Other Pre-specified:   Disease Control (Update)   [ Time Frame: From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks ]

Measure Type Other Pre-specified
Measure Title Disease Control (Update)
Measure Description Disease control was defined as the percentage of participants who had a best response rating of CR (tumor disappears), PR (sum of lesion sizes decreased at least 30% from baseline), or SD (steady state of disease) that was maintained for at least 28 days from the first demonstration of that rating.
Time Frame From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks  
Safety Issue No  

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.
Evaluable for response (Primary analysis population)

Reporting Groups
  Description
Regorafenib (Stivarga, BAY73-4506) Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle

Measured Values
    Regorafenib (Stivarga, BAY73-4506)  
Number of Participants Analyzed  
[units: participants]
  48  
Disease Control (Update)  
[units: Percentage of participants]
  62.5  

No statistical analysis provided for Disease Control (Update)



12.  Other Pre-specified:   Overall Survival (Update)   [ Time Frame: From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). ]

Measure Type Other Pre-specified
Measure Title Overall Survival (Update)
Measure Description Overall survival (OS) was calculated as the time from the first date of receiving study medication to death, due to any cause. Participants alive at the time of analysis were censored at their last date of follow-up.
Time Frame From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011).  
Safety Issue No  

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.
intention-to-treat (ITT)

Reporting Groups
  Description
Regorafenib (Stivarga, BAY73-4506) Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle

Measured Values
    Regorafenib (Stivarga, BAY73-4506)  
Number of Participants Analyzed  
[units: participants]
  49  
Overall Survival (Update)  
[units: Days]
Median ( 95% Confidence Interval )
  NA  
  ( 735 to NA ) [1]
[1] Not estimable due to censored data.

No statistical analysis provided for Overall Survival (Update)



13.  Other Pre-specified:   Progression-free Survival (Update)   [ Time Frame: From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks ]

Measure Type Other Pre-specified
Measure Title Progression-free Survival (Update)
Measure Description PFS was calculated as time from first date of receiving study drug until date of first observed disease progression (PD) (radiological or clinical, whichever was earlier) or death due to any cause, if death occurred before PD was documented. The actual date of tumor assessments (i.e., date on which radiological procedure was performed, rather than scheduled date) was used for this calculation to determine both the event date and censoring date. Patients without PD or death at time of analysis were censored at last date of tumor evaluation.
Time Frame From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks  
Safety Issue No  

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.
intention-to-treat (ITT)

Reporting Groups
  Description
Regorafenib (Stivarga, BAY73-4506) Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle

Measured Values
    Regorafenib (Stivarga, BAY73-4506)  
Number of Participants Analyzed  
[units: participants]
  49  
Progression-free Survival (Update)  
[units: Days]
Median ( 95% Confidence Interval )
  335  
  ( 167 to 438 )  

No statistical analysis provided for Progression-free Survival (Update)



14.  Other Pre-specified:   Time to Progression (Update)   [ Time Frame: From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks ]

Measure Type Other Pre-specified
Measure Title Time to Progression (Update)
Measure Description TTP was calculated as time from first date of receiving study drug until date of first documented disease progression (PD) (radiological or clinical, whichever was earlier). The actual date of tumor assessments (i.e., date on which radiological procedure was performed, rather than the scheduled date) was used for this calculation to determine both the event date and censoring date. Patients without PD at time of analysis were censored at last date of tumor evaluation.
Time Frame From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks  
Safety Issue No  

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.
intention-to-treat (ITT)

Reporting Groups
  Description
Regorafenib (Stivarga, BAY73-4506) Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle

Measured Values
    Regorafenib (Stivarga, BAY73-4506)  
Number of Participants Analyzed  
[units: participants]
  49  
Time to Progression (Update)  
[units: Days]
Median ( 95% Confidence Interval )
  335  
  ( 167 to 454 )  

No statistical analysis provided for Time to Progression (Update)



15.  Other Pre-specified:   Duration of Response (Update)   [ Time Frame: From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks ]

Measure Type Other Pre-specified
Measure Title Duration of Response (Update)
Measure Description Duration of response was defined as the time from the first documented objective response of PR or CR, whichever was earlier, to disease progression or death (if death occurred before progression was documented). Duration of response for subjects who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment.
Time Frame From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks  
Safety Issue No  

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.
Only subjects from ITT population with a response of CR or PR were included in this evaluation.

Reporting Groups
  Description
Regorafenib (Stivarga, BAY73-4506) Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle

Measured Values
    Regorafenib (Stivarga, BAY73-4506)  
Number of Participants Analyzed  
[units: participants]
  19  
Duration of Response (Update)  
[units: Days]
Median ( 95% Confidence Interval )
  428  
  ( 250 to 540 )  

No statistical analysis provided for Duration of Response (Update)



16.  Other Pre-specified:   Duration of Stable Disease (Update)   [ Time Frame: From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks ]

Measure Type Other Pre-specified
Measure Title Duration of Stable Disease (Update)
Measure Description Duration of SD was calculated as the time from the first date of receiving study drug until the date of documented PD or the last observation if the subject did not progress. Subjects without disease progression at the time of analysis were censored at the last date of tumor evaluation.
Time Frame From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks  
Safety Issue No  

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.
Subjects from ITT population who achieved objective response of CR or PR were excluded from this evaluation.

Reporting Groups
  Description
Regorafenib (Stivarga, BAY73-4506) Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle

Measured Values
    Regorafenib (Stivarga, BAY73-4506)  
Number of Participants Analyzed  
[units: participants]
  25  
Duration of Stable Disease (Update)  
[units: Days]
Median ( 95% Confidence Interval )
  119  
  ( 105 to 335 )  

No statistical analysis provided for Duration of Stable Disease (Update)




  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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