Nexavar® Versus Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer
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| ClinicalTrials.gov Identifier: NCT00984282 |
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Recruitment Status :
Completed
First Posted : September 25, 2009
Results First Posted : December 10, 2013
Last Update Posted : September 13, 2018
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Sponsor:
Bayer
Collaborator:
Amgen
Information provided by (Responsible Party):
Bayer
- Study Details
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition |
Thyroid Neoplasms |
| Interventions |
Drug: Sorafenib (Nexavar, BAY43-9006) Drug: Placebo |
| Enrollment | 417 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details | Of 556 screened participants, 137 failed screening, 207 were randomized to receive sorafenib, 210 were randomized to placebo. |
| Arm/Group Title | DB Sorafenib First, Then Option of OL Sorafenib Treatment | DB Placebo First, Then Option of OL Sorafenib Treatment |
|---|---|---|
 Arm/Group Description |
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. | 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. |
| Period Title: Double Blind Treatment | ||
| Started | 207 | 210 |
| Received Treatment | 207 [1] | 209 [2] |
| Completed | 103 | 172 |
| Not Completed | 104 | 38 |
| Reason Not Completed | ||
| Adverse Event | 40 | 6 |
| Progression, recurrence or relapse | 25 | 3 |
| Physician Decision | 1 | 2 |
| Noncompliance with study medication | 3 | 0 |
| Progression by clinical judgment | 2 | 0 |
| Withdrawal by Subject | 13 | 18 |
| Lost to Follow-up | 3 | 0 |
| Death | 8 | 4 |
| Not treated | 0 | 1 |
| Switched to commercial drug | 6 | 1 |
| protocol driven decision point | 1 | 1 |
| Radiological and clinical progression | 0 | 1 |
| Transferred to treat. continuation study | 2 | 1 |
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[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)
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| Period Title: Open-label Treatment | ||
| Started | 86 | 161 |
| Received Treatment | 86 [1] | 161 [2] |
| Completed | 0 | 0 |
| Not Completed | 86 | 161 |
| Reason Not Completed | ||
| Adverse Event | 20 | 30 |
| Withdrawal by Subject | 6 | 21 |
| Death | 7 | 15 |
| Progression, recurrence or relapse | 40 | 82 |
| Lost to Follow-up | 1 | 1 |
| Patient convenience | 1 | 0 |
| Non-compliant with study medication | 1 | 0 |
| Target lesion removed | 0 | 1 |
| Protocol driven decision point | 1 | 1 |
| Transferred to treat. continuation study | 2 | 3 |
| Switched to commercial drug | 6 | 7 |
| Physician Decision | 1 | 0 |
|
[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)
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| Period Title: Long Term Follow-up | ||
| Started | 72 [1] | 124 [1] |
| Completed | 3 | 4 |
| Not Completed | 69 | 120 |
| Reason Not Completed | ||
| Withdrawal by Subject | 8 | 14 |
| Death | 27 | 68 |
| Lost to Follow-up | 3 | 6 |
| Protocol driven decision point | 25 | 26 |
| Transferred to treat. continuation study | 2 | 3 |
| Switched to commercial drug | 4 | 2 |
| Disease prog., recurrence or relapse | 0 | 1 |
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[1]
Participants entered long-term follow-up if terminated double-blind or open-label periods
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Baseline Characteristics
| Arm/Group Title | Sorafenib (Nexavar, BAY43-9006) | Placebo | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle. | Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 207 | 210 | 417 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||
| Number Analyzed | 207 participants | 210 participants | 417 participants | |
| 61.5 (11.2) | 62.0 (11.7) | 61.8 (11.4) | ||
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Age, Customized
Measure Type: Count of Participants Unit of measure: Participants |
||||
| Number Analyzed | 207 participants | 210 participants | 417 participants | |
| < 60 years |
80 38.6%
|
81 38.6%
|
161 38.6%
|
|
| >= 60 years |
127 61.4%
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129 61.4%
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256 61.4%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 207 participants | 210 participants | 417 participants | |
| Female |
103 49.8%
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115 54.8%
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218 52.3%
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| Male |
104 50.2%
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95 45.2%
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199 47.7%
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Geographic region
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 207 participants | 210 participants | 417 participants | |
| Europe |
124 59.9%
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125 59.5%
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249 59.7%
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| North America |
36 17.4%
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36 17.1%
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72 17.3%
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| Asia |
47 22.7%
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49 23.3%
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96 23.0%
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ECOG (Eastern Cooperative Oncology Group) performance status
[1] Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 207 participants | 210 participants | 417 participants | |
| Missing |
1 0.5%
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1 0.5%
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2 0.5%
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|
| 0 |
130 62.8%
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129 61.4%
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259 62.1%
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|
| 1 |
69 33.3%
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74 35.2%
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143 34.3%
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| 2 |
7 3.4%
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6 2.9%
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13 3.1%
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[1]
Measure Description: 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)
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Site of target/nontarget lesions at baseline - organ class
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 207 participants | 210 participants | 417 participants |
| Lung | 178 | 181 | 359 | |
| Lymph node | 113 | 101 | 214 | |
| Bone | 57 | 56 | 113 | |
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[1]
Measure Description: Participants could have had more than one site.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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 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 |
| EMail: | clinical-trials-contact@bayer.com |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00984282 |
| Other Study ID Numbers: |
14295 2009-012007-25 ( EudraCT Number ) |
| First Submitted: | September 24, 2009 |
| First Posted: | September 25, 2009 |
| Results First Submitted: | August 19, 2013 |
| Results First Posted: | December 10, 2013 |
| Last Update Posted: | September 13, 2018 |