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

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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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

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

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.  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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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) ]

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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