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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


  Other 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).

Frequency Threshold
Threshold above which other adverse events are reported   5  

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

Other Adverse Events
    Regorafenib (Stivarga, BAY73-4506)
Total, other (not including serious) adverse events   
# participants affected / at risk   48/49 (97.96%) 
Blood and lymphatic system disorders   
Hemoglobin * 1   
# participants affected / at risk   4/49 (8.16%) 
# events   4 
Platelets * 1   
# participants affected / at risk   6/49 (12.24%) 
# events   15 
Edema: Limb * 1   
# participants affected / at risk   4/49 (8.16%) 
# events   6 
Edema: Trunk/Genital * 1   
# participants affected / at risk   3/49 (6.12%) 
# events   3 
Cardiac disorders   
Hypertension * 1   
# participants affected / at risk   26/49 (53.06%) 
# events   30 
Gastrointestinal disorders   
Anorexia * 1   
# participants affected / at risk   15/49 (30.61%) 
# events   30 
Constipation * 1   
# participants affected / at risk   16/49 (32.65%) 
# events   27 
Dehydration * 1   
# participants affected / at risk   3/49 (6.12%) 
# events   3 
Diarrhea * 1   
# participants affected / at risk   23/49 (46.94%) 
# events   86 
Dysphagia * 1   
# participants affected / at risk   4/49 (8.16%) 
# events   4 
Gastritis * 1   
# participants affected / at risk   5/49 (10.20%) 
# events   6 
Mucositis (Functional/Symptomatic), Oral Cavity * 1   
# participants affected / at risk   23/49 (46.94%) 
# events   66 
Mucositis (Clinical Exam), Oral Cavity * 1   
# participants affected / at risk   4/49 (8.16%) 
# events   6 
Nausea * 1   
# participants affected / at risk   16/49 (32.65%) 
# events   26 
GI - Other * 1   
# participants affected / at risk   3/49 (6.12%) 
# events   4 
Taste Alteration * 1   
# participants affected / at risk   6/49 (12.24%) 
# events   8 
Vomiting * 1   
# participants affected / at risk   14/49 (28.57%) 
# events   24 
General disorders   
Fever * 1   
# participants affected / at risk   10/49 (20.41%) 
# events   14 
Insomnia * 1   
# participants affected / at risk   7/49 (14.29%) 
# events   7 
Fatigue * 1   
# participants affected / at risk   25/49 (51.02%) 
# events   43 
Weight Loss * 1   
# participants affected / at risk   8/49 (16.33%) 
# events   9 
Constitutional Symptoms - Other * 1   
# participants affected / at risk   6/49 (12.24%) 
# events   6 
Rigors/Chills * 1   
# participants affected / at risk   3/49 (6.12%) 
# events   3 
Sweating * 1   
# participants affected / at risk   9/49 (18.37%) 
# events   9 
Pain, Back * 1   
# participants affected / at risk   12/49 (24.49%) 
# events   16 
Pain, Chest/Thorax NOS * 1   
# participants affected / at risk   7/49 (14.29%) 
# events   7 
Pain, Chest Wall * 1   
# participants affected / at risk   5/49 (10.20%) 
# events   6 
Pain, Extremity - Limb * 1   
# participants affected / at risk   7/49 (14.29%) 
# events   7 
Pain, Abdomen NOS * 1   
# participants affected / at risk   12/49 (24.49%) 
# events   19 
Pain, Head/Headache * 1   
# participants affected / at risk   14/49 (28.57%) 
# events   21 
Pain, Joint * 1   
# participants affected / at risk   6/49 (12.24%) 
# events   16 
Pain, Muscle * 1   
# participants affected / at risk   8/49 (16.33%) 
# events   10 
Pain, Bone * 1   
# participants affected / at risk   5/49 (10.20%) 
# events   13 
Pain, Other * 1   
# participants affected / at risk   9/49 (18.37%) 
# events   17 
Pain, Pain NOS * 1   
# participants affected / at risk   3/49 (6.12%) 
# events   3 
Pain, Scalp * 1   
# participants affected / at risk   3/49 (6.12%) 
# events   4 
Immune system disorders   
Rhinitis * 1   
# participants affected / at risk   3/49 (6.12%) 
# events   4 
Allergic Reaction * 1   
# participants affected / at risk   4/49 (8.16%) 
# events   4 
Infections and infestations   
Infection (Documented Clinically), Bladder (Urinary) * 1   
# participants affected / at risk   4/49 (8.16%) 
# events   4 
Infection (Documented Clinically), Bronchus * 1   
# participants affected / at risk   3/49 (6.12%) 
# events   3 
Infection (Documented Clinically), Upper Airway NOS * 1   
# participants affected / at risk   7/49 (14.29%) 
# events   7 
Infection - Other * 1   
# participants affected / at risk   4/49 (8.16%) 
# events   5 
Metabolism and nutrition disorders   
Amylase * 1   
# participants affected / at risk   5/49 (10.20%) 
# events   5 
Creatinine * 1   
# participants affected / at risk   3/49 (6.12%) 
# events   3 
Hyperuricemia * 1   
# participants affected / at risk   4/49 (8.16%) 
# events   7 
Lipase * 1   
# participants affected / at risk   6/49 (12.24%) 
# events   9 
Hyponatremia * 1   
# participants affected / at risk   4/49 (8.16%) 
# events   7 
Musculoskeletal and connective tissue disorders   
Musculoskeletal - Other * 1   
# participants affected / at risk   3/49 (6.12%) 
# events   8 
Nervous system disorders   
Dizziness * 1   
# participants affected / at risk   4/49 (8.16%) 
# events   4 
Neuropathy: Sensory * 1   
# participants affected / at risk   8/49 (16.33%) 
# events   17 
Respiratory, thoracic and mediastinal disorders   
Cough * 1   
# participants affected / at risk   5/49 (10.20%) 
# events   6 
Dyspnea (Shortness Of Breath) * 1   
# participants affected / at risk   16/49 (32.65%) 
# events   21 
Voice Changes * 1   
# participants affected / at risk   17/49 (34.69%) 
# events   23 
Skin and subcutaneous tissue disorders   
Alopecia * 1   
# participants affected / at risk   22/49 (44.90%) 
# events   25 
Dry Skin * 1   
# participants affected / at risk   4/49 (8.16%) 
# events   4 
Hand-Foot Skin Reaction * 1   
# participants affected / at risk   35/49 (71.43%) 
# events   85 
Dermatology - Other * 1   
# participants affected / at risk   11/49 (22.45%) 
# events   18 
Pruritus * 1   
# participants affected / at risk   4/49 (8.16%) 
# events   8 
Rash/Desquamation * 1   
# participants affected / at risk   22/49 (44.90%) 
# events   32 
* Events were collected by non-systematic assessment
1 Term from vocabulary, NCI-CTCAE v.3.0



  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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