This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Nexavar® Versus Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00984282
First received: September 24, 2009
Last updated: January 13, 2017
Last verified: January 2017
History of Changes
Results First Received: August 19, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Thyroid Neoplasms
Interventions: Drug: Sorafenib (Nexavar, BAY43-9006)
Drug: Placebo

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 556 enrolled participants, 137 failed screening, 209 were randomized to receive sorafenib, 210 were randomized to placebo. One participant was never treated (placebo) and 2 were randomized by mistake (sorafenib) then re-randomized with different subject numbers. Therefore, 207 participants received sorafenib and 209 received placebo.

Reporting Groups
  Description
DB Sorafenib First, Then Option of OL Sorafenib Treatment Double-blind period: Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle. Open-label (OL) period: Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle.
DB Placebo First, Then Option of OL Sorafenib Treatment Double-blind period: participants received matching placebo tablets orally twice daily, 28 days comprised a cycle. Open-label (OL) period: participants on placebo who switched to sorafenib, received sorafenib 400 mg (2 x 200 mg) orally twice daily, 28 days comprise a cycle.

Participant Flow for 3 periods

 Period 1:   Double Blind Treatment
    DB Sorafenib First, Then Option of OL Sorafenib Treatment   DB Placebo First, Then Option of OL Sorafenib Treatment
STARTED   207   210 
Received Treatment   207 [1]   209 [2] 
COMPLETED   103   172 
NOT COMPLETED   104   38 
Adverse Event                38                6 
Progression, recurrence or relapse                24                3 
Physician Decision                1                2 
Noncompliance with study medication                3                0 
Progression by clinical judgment                1                0 
Withdrawal by Subject                14                18 
Lost to Follow-up                3                0 
Death                8                4 
Not treated                0                1 
Switched to follow-up                12                4 
[1] Subjects at Risk/Safety Population - in RG1 (RG= Reporting Group for Safety Data)
[2] Subjects at Risk/Safety Population - in RG2 (RG= Reporting Group for Safety Data)

Period 2:   Open-label Treatment
    DB Sorafenib First, Then Option of OL Sorafenib Treatment   DB Placebo First, Then Option of OL Sorafenib Treatment
STARTED   86   161 
Received Treatment   86 [1]   161 [2] 
COMPLETED   0   0 
NOT COMPLETED   86   161 
Adverse Event                17                29 
Withdrawal by Subject                6                21 
Death                5                15 
Progression, recurrence or relapse                37                77 
Lost to Follow-up                1                0 
Ongoing with treatment                19                18 
Non-compliant with study medication                1                0 
Target lesion removed                0                1 
[1] Subjects at Risk/Safety Population - in RG3 (RG= Reporting Group for Safety Data)
[2] Subjects at Risk/Safety Population - in RG4 (RG= Reporting Group for Safety Data)

Period 3:   Long Term Follow-up
    DB Sorafenib First, Then Option of OL Sorafenib Treatment   DB Placebo First, Then Option of OL Sorafenib Treatment
STARTED   114 [1]   117 [1] 
COMPLETED   0   0 
NOT COMPLETED   114   117 
Withdrawal by Subject                18                15 
Death                55                72 
Lost to Follow-up                8                4 
Ongoing with treatment                33                26 
[1] Participants entered long-term follow-up if terminated double-blind or open-label periods



  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
Sorafenib (Nexavar, BAY43-9006) Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle.
Placebo Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle.
Total Total of all reporting groups

Baseline Measures
   Sorafenib (Nexavar, BAY43-9006)   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 207   210   417 
Age 
[Units: Years]
Mean (Standard Deviation) 		 61.5  (11.2)   62.0  (11.7)   61.8  (11.4) 
Age, Customized 
[Units: Participants]
 		     
< 60 years   80   81   161 
>= 60 years   127   129   256 
Gender 
[Units: Participants]
Count of Participants 		     
Female      103  49.8%      115  54.8%      218  52.3% 
Male      104  50.2%      95  45.2%      199  47.7% 
Geographic region 
[Units: Participants]
 		     
Europe   124   125   249 
North America   36   36   72 
Asia   47   49   96 
ECOG (Eastern Cooperative Oncology Group) performance status [1] 
[Units: Participants]
 		     
Missing   1   1   2 
0   130   129   259 
1   69   74   143 
2   7   6   13 
[1] The ECOG PS required for the study was 0 (fully active), 1 (restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature), or 2 (ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours)
Site of target/nontarget lesions at baseline - organ class [1] 
[Units: Participants]
 		     
Lung   178   181   359 
Lymph node   113   101   214 
Bone   57   56   113 
[1] Participants could have had more than one site.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-free Survival (PFS) Based on Central Assessment Incl. Clinical Progression Due to Bone Irradiation   [ Time Frame: Final analysis to be performed when approximately 267 progression-free survival events (centrally assessed) had occurred, study duration approximately three years ]
  Show Outcome Measure 1

2.  Secondary:   Overall Survival (OS)   [ Time Frame: From randomization of the first subject until the database cut-off (14 Jul 2015), study duration approximately six years ]
  Show Outcome Measure 2

3.  Secondary:   Time to Progression (TTP) Based on Central Assessment Incl. Clinical Progression Due to Bone Irradiation   [ Time Frame: From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years ]
  Show Outcome Measure 3

4.  Secondary:   Disease Control Rate (DCR) Based on Central Assessment   [ Time Frame: From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years ]
  Show Outcome Measure 4

5.  Secondary:   Response Rate Based on Central Assessment   [ Time Frame: From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years ]
  Show Outcome Measure 5

6.  Secondary:   Duration of Response (DOR) Based on Central Assessment   [ Time Frame: From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years ]
  Show Outcome Measure 6

7.  Secondary:   Maximum Percent Reduction in Target Lesion Size Based on Central Assessment   [ Time Frame: From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years ]
  Show Outcome Measure 7

8.  Secondary:   AUC(0-12h),ss (Area Under the Concentration Time Curve From Time 0 to 12 Hours at Steady State)   [ Time Frame: A single pharmacokinetic plasma sample was collected at steady state (after 14 days of uninterrupted, unmodified sorafenib dosing) ]
  Show Outcome Measure 8


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show 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
  Show More Information