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

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ClinicalTrials.gov Identifier: NCT00664326
Recruitment Status : Active, not recruiting
First Posted : April 22, 2008
Results First Posted : November 28, 2012
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Carcinoma, Renal Cell
Intervention: Drug: Regorafenib (Stivarga, BAY73-4506)

  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

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) 
Overall Participants Analyzed 
[Units: Participants]
 		 49 
Age 
[Units: Years]
Median (Full Range) 		 62.0 
 (40 to 76) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		 
Female      22  44.9% 
Male      27  55.1% 
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) [1] 
[Units: Participants]
 		 
0   30 
1   19 
[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.
Overall Motzer Score [1] 
[Units: Participants]
 		 
Low   24 
Intermediate   25 
[1] 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

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 ]
  Show Outcome Measure 1

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 ]
  Show Outcome Measure 2

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 ]
  Show Outcome Measure 3

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

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 ]
  Show Outcome Measure 5

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 ]
  Show Outcome Measure 6

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 ]
  Show Outcome Measure 7

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 ]
  Show Outcome Measure 8

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 ]
  Show Outcome Measure 9

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 ]
  Show Outcome Measure 10

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 ]
  Show Outcome Measure 11

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). ]
  Show Outcome Measure 12

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 ]
  Show Outcome Measure 13

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 ]
  Hide Outcome Measure 14

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  

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) 
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 ]
  Show Outcome Measure 15

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 ]
  Show Outcome Measure 16


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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