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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: September 28, 2016
Last verified: September 2016
Results First Received: October 28, 2012  
Study Type: Interventional
Study Design: 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
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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
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
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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
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) 
Gender 
[Units: Participants]
 
Female   22 
Male   27 
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) [1] 
[Units: Participants]
 
 30 
 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
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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
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Time Frame No text entered.
Additional Description Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).

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

Serious Adverse Events
    Regorafenib (Stivarga, BAY73-4506)
Total, serious adverse events   
# participants affected / at risk   30/49 (61.22%) 
Blood and lymphatic system disorders   
Hemoglobin * 1   
# participants affected / at risk   1/49 (2.04%) 
# events   1 
Cardiac disorders   
Supraventricular Arrhythmia, Atrial Fibrillation * 1   
# participants affected / at risk   1/49 (2.04%) 
# events   1 
Cardiac Arrest * 1   
# participants affected / at risk   1/49 (2.04%) 
# events   1 
Cardiac Ischemia/Infarction * 1   
# participants affected / at risk   4/49 (8.16%) 
# events   4 
Gastrointestinal disorders   
Diarrhea * 1   
# participants affected / at risk   1/49 (2.04%) 
# events   1 
Obstruction, GI, Small Bowel NOS * 1   
# participants affected / at risk   1/49 (2.04%) 
# events   1 
Perforation, GI, Colon * 1   
# participants affected / at risk   1/49 (2.04%) 
# events   1 
Perforation, GI, Stomach * 1   
# participants affected / at risk   1/49 (2.04%) 
# events   1 
Stricture, GI, Biliary Tree * 1   
# participants affected / at risk   1/49 (2.04%) 
# events   1 
Vomiting * 1   
# participants affected / at risk   1/49 (2.04%) 
# events   1 
General disorders   
Fever * 1   
# participants affected / at risk   2/49 (4.08%) 
# events   2 
Fatigue * 1   
# participants affected / at risk   3/49 (6.12%) 
# events   3 
Constitutional Symptoms - Other * 1   
# participants affected / at risk   1/49 (2.04%) 
# events   1 
Pain, Back * 1   
# participants affected / at risk   3/49 (6.12%) 
# events   3 
Pain, Buttock * 1   
# participants affected / at risk   1/49 (2.04%) 
# events   1 
Pain, Cardiac/Heart * 1   
# participants affected / at risk   1/49 (2.04%) 
# events   1 
Pain, Chest/Thorax NOS * 1   
# participants affected / at risk   1/49 (2.04%) 
# events   1 
Pain, Abdomen NOS * 1   
# participants affected / at risk   2/49 (4.08%) 
# events   2 
Pain, Bone * 1   
# participants affected / at risk   1/49 (2.04%) 
# events   1 
Pain, Other * 1   
# participants affected / at risk   2/49 (4.08%) 
# events   2 
Hepatobiliary disorders   
Cholecystitis * 1   
# participants affected / at risk   1/49 (2.04%) 
# events   1 
Liver Dysfunction * 1   
# participants affected / at risk   1/49 (2.04%) 
# events   1 
Infections and infestations   
Infection (Documented Clinically), Abdomen NOS * 1   
# participants affected / at risk   1/49 (2.04%) 
# events   1 
Infection (Documented Clinically), Blood * 1   
# participants affected / at risk   1/49 (2.04%) 
# events   2 
Infection (Doc. Clinic), foreign Body (e.g. Graft, Implant, Pros, Stent) * 1   
# participants affected / at risk   1/49 (2.04%) 
# events   1 
Infection (Documented Clinically), Gallbladder (Cholecystitis) * 1   
# participants affected / at risk   1/49 (2.04%) 
# events   1 
Infection (Documented Clinically), Skin (Cellulitis) * 1   
# participants affected / at risk   1/49 (2.04%) 
# events   1 
Infection - Other * 1   
# participants affected / at risk   1/49 (2.04%) 
# events   1 
Infection With Unknown ANC, Lung (Pneumonia) * 1   
# participants affected / at risk   1/49 (2.04%) 
# events   1 
Injury, poisoning and procedural complications   
Intraop Injury - Other * 1   
# participants affected / at risk   1/49 (2.04%) 
# events   1 
Metabolism and nutrition disorders   
Hypocalcemia * 1   
# participants affected / at risk   1/49 (2.04%) 
# events   1 
Hypomagnesemia * 1   
# participants affected / at risk   1/49 (2.04%) 
# events   1 
Musculoskeletal and connective tissue disorders   
Fracture * 1   
# participants affected / at risk   2/49 (4.08%) 
# events   2 
Muscle Weakness, Extremity - Upper * 1   
# participants affected / at risk   1/49 (2.04%) 
# events   1 
Nervous system disorders   
Confusion * 1   
# participants affected / at risk   1/49 (2.04%) 
# events   1 
Syncope * 1   
# participants affected / at risk   2/49 (4.08%) 
# events   4 
Renal and urinary disorders   
Renal Failure * 1   
# participants affected / at risk   5/49 (10.20%) 
# events   6 
Respiratory, thoracic and mediastinal disorders   
Pleural Effusion * 1   
# participants affected / at risk   2/49 (4.08%) 
# events   2 
Airway Obstruction, Larynx * 1   
# participants affected / at risk   1/49 (2.04%) 
# events   1 
Skin and subcutaneous tissue disorders   
Hand-Foot Skin Reaction * 1   
# participants affected / at risk   1/49 (2.04%) 
# events   1 
Rash/Desquamation * 1   
# participants affected / at risk   2/49 (4.08%) 
# events   2 
Vascular disorders   
Hemorrhage, GI, Upper GI NOS * 1   
# participants affected / at risk   1/49 (2.04%) 
# events   1 
Hemorrhage Pulmonary, Nose * 1   
# participants affected / at risk   1/49 (2.04%) 
# events   2 
Hemorrhage Pulmonary, Respiratory Tract NOS * 1   
# participants affected / at risk   1/49 (2.04%) 
# events   1 
Thrombosis/Thrombus/Embolism * 1   
# participants affected / at risk   1/49 (2.04%) 
# events   1 
* Events were collected by non-systematic assessment
1 Term from vocabulary, NCI-CTCAE v.3.0




  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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