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

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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.
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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

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

Asia

ECOG (Eastern Cooperative Oncology Group) performance status ^[1]
[Units: Participants]

Missing

130

129

259

143

^[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

113

^[1]	Participants could have had more than one site.

Outcome Measures

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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) ]

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Serious Adverse Events

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Other Adverse Events

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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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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The investigator must discuss any publication with the sponsor prior to release and obtain written consent of the sponsor on the intended publication. He/she must send a draft manuscript of the publication 30 days in advance of submission in order to obtain approval prior to submission of the final version for publication. In case of a difference of opinion, the contents will be discussed in order to find a solution which satisfies both parties.

Results Point of Contact:

Name/Title: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com

Publications of Results:

Worden F, Fassnacht M, Shi Y, Hadjieva T, Bonichon F, Gao M, Fugazzola L, Ando Y, Hasegawa Y, Park DJ, Shong YK, Smit JW, Chung J, Kappeler C, Meinhardt G, Schlumberger M, Brose MS. Safety and tolerability of sorafenib in patients with radioiodine-refractory thyroid cancer. Endocr Relat Cancer. 2015 Dec;22(6):877-87. doi: 10.1530/ERC-15-0252.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Brose MS, Nutting CM, Jarzab B, Elisei R, Siena S, Bastholt L, de la Fouchardiere C, Pacini F, Paschke R, Shong YK, Sherman SI, Smit JW, Chung J, Kappeler C, Peña C, Molnár I, Schlumberger MJ; DECISION investigators. Sorafenib in radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer: a randomised, double-blind, phase 3 trial. Lancet. 2014 Jul 26;384(9940):319-28. doi: 10.1016/S0140-6736(14)60421-9. Epub 2014 Apr 24.

Brose MS, Nutting CM, Sherman SI, Shong YK, Smit JW, Reike G, Chung J, Kalmus J, Kappeler C, Schlumberger M. Rationale and design of decision: a double-blind, randomized, placebo-controlled phase III trial evaluating the efficacy and safety of sorafenib in patients with locally advanced or metastatic radioactive iodine (RAI)-refractory, differentiated thyroid cancer. BMC Cancer. 2011 Aug 11;11:349. doi: 10.1186/1471-2407-11-349.

Responsible Party:	Bayer
ClinicalTrials.gov Identifier:	NCT00984282 History of Changes
Other Study ID Numbers:	14295 2009-012007-25 ( EudraCT Number )
Study First Received:	September 24, 2009
Results First Received:	August 19, 2013
Last Updated:	January 13, 2017

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