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


  Outcome Measures
  Show 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 ]

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 ]

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 ]

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

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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). ]

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 ]

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 ]

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 ]

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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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