NCT00984282 · STUDY IN CONTEXT

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

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

PFS=time from randomization to first observed disease progression (radiological according to central assessment or clinical due to bone irradiation, whichever is earlier), or death due to any cause, if death occurred before progression. Progression was assessed by RECIST criteria, version 1.0, modified for bone lesions. PFS for participants without disease progression or death at the time of analysis or unblinding were censored at the last date of tumor assessment before unblinding. Participants with no tumor evaluation after baseline were censored at Day 1. PD (Progression Disease)=At least a 20% increase in sum of longest diameters (LD) of measured lesions taking as reference the smallest sum LD on study since the treatment started or the appearance of 1 or more new lesions. New lesions also constituted PD. In exceptional circumstances, unequivocal progression of a nonmeasured lesion may have been accepted as evidence of disease progression in participants with measurable disease.

Full Analysis Set (FAS). The primary population for efficacy analysis was the FAS. The FAS was identical to the intent-to-treat (ITT) population, which was defined as all randomized participants. Participants were analyzed as randomized.

→

secondary · POSTED

Overall survival was defined as the time (days) from date of randomization to date of death due to any cause. Subjects still alive at the time of analysis were censored at their date of last contact. Since the median value could not be estimated due to censored data, the percentage of participants who died is presented.

Full Analysis Set (FAS)

→

secondary · POSTED

Time to progression was defined at the time (days) from randomization to progression (based on central assessment \[radiological and clinical progression due to bone irradiation\])

FAS

→

secondary · POSTED

Disease control rate was defined as the proportion of subjects whose best response was complete response (CR), partial response (PR), or stable disease (SD). Per Response Evaluation Criteria in Solid Tumors (RECIST) criteria, CR and PR were to be confirmed by another scan at least 4 weeks later; SD had to be documented at least 4 weeks after date of randomization. CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). PR = At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum. SD = steady state of disease which is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

Per protocol set (PPS). A participant was included in the PPS if he/she was randomized and was evaluable for tumor response based on imaging data, had exposure to study medication, and had no major protocol deviations.

→

secondary · POSTED

Response rate was defined as the proportion of subjects whose best response was CR or PR. Per RECIST, CR and PR was to be confirmed by another scan at least 4 weeks later. CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). PR = At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum.

PPS

→

secondary · POSTED

Duration of response was defined as the time from the first documented objective response of PR or CR, whichever was noted earlier, to disease progression or death (if death occurred before progression was documented). CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). PR = At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum.

FAS - responders only

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-head-and-neck-neoplasm
nct id: NCT00984282
trial label: Nexavar® Versus Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 6
harms Count: 4
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT00984282
outcome key
om-0000
source section id
NCT00984282-om-0000
source outcome index
0
endpoint
Progression-free Survival (PFS) Based on Central Assessment Incl. Clinical Progression Due to Bone Irradiation
endpoint definition
PFS=time from randomization to first observed disease progression (radiological according to central assessment or clinical due to bone irradiation, whichever is earlier), or death due to any cause, if death occurred before progression. Progression was assessed by RECIST criteria, version 1.0, modified for bone lesions. PFS for participants without disease progression or death at the time of analysis or unblinding were censored at the last date of tumor assessment before unblinding. Participants with no tumor evaluation after baseline were censored at Day 1. PD (Progression Disease)=At least a 20% increase in sum of longest diameters (LD) of measured lesions taking as reference the smallest sum LD on study since the treatment started or the appearance of 1 or more new lesions. New lesions also constituted PD. In exceptional circumstances, unequivocal progression of a nonmeasured lesion may have been accepted as evidence of disease progression in participants with measurable disease.
time origin
Final analysis to be performed when approximately 267 progression-free survival events (centrally assessed) had occurred, study duration approximately three years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Full Analysis Set (FAS). The primary population for efficacy analysis was the FAS. The FAS was identical to the intent-to-treat (ITT) population, which was defined as all randomized participants. Participants were analyzed as randomized.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT00984282
outcome key
om-0001
source section id
NCT00984282-om-0001
source outcome index
1
endpoint
Overall Survival (OS)
endpoint definition
Overall survival was defined as the time (days) from date of randomization to date of death due to any cause. Subjects still alive at the time of analysis were censored at their date of last contact. Since the median value could not be estimated due to censored data, the percentage of participants who died is presented.
time origin
From randomization of the first subject until the database cut-off (30 AUG 2017), study duration approximately eight years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Full Analysis Set (FAS)
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT00984282
outcome key
om-0002
source section id
NCT00984282-om-0002
source outcome index
2
endpoint
Time to Progression (TTP) Based on Central Assessment Incl. Clinical Progression Due to Bone Irradiation
endpoint definition
Time to progression was defined at the time (days) from randomization to progression (based on central assessment \[radiological and clinical progression due to bone irradiation\])
time origin
From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
FAS
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT00984282
outcome key
om-0003
source section id
NCT00984282-om-0003
source outcome index
3
endpoint
Disease Control Rate (DCR) Based on Central Assessment
endpoint definition
Disease control rate was defined as the proportion of subjects whose best response was complete response (CR), partial response (PR), or stable disease (SD). Per Response Evaluation Criteria in Solid Tumors (RECIST) criteria, CR and PR were to be confirmed by another scan at least 4 weeks later; SD had to be documented at least 4 weeks after date of randomization. CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). PR = At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum. SD = steady state of disease which is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
time origin
From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Per protocol set (PPS). A participant was included in the PPS if he/she was randomized and was evaluable for tumor response based on imaging data, had exposure to study medication, and had no major protocol deviations.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT00984282
outcome key
om-0004
source section id
NCT00984282-om-0004
source outcome index
4
endpoint
Response Rate Based on Central Assessment
endpoint definition
Response rate was defined as the proportion of subjects whose best response was CR or PR. Per RECIST, CR and PR was to be confirmed by another scan at least 4 weeks later. CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). PR = At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum.
time origin
From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
PPS
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT00984282
outcome key
om-0005
source section id
NCT00984282-om-0005
source outcome index
5
endpoint
Duration of Response (DOR) Based on Central Assessment
endpoint definition
Duration of response was defined as the time from the first documented objective response of PR or CR, whichever was noted earlier, to disease progression or death (if death occurred before progression was documented). CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). PR = At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum.
time origin
From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
FAS - responders only
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT00984282
outcome key
om-0000
arm key
OG000
arm label
Sorafenib (Nexavar, BAY43-9006)
regimen
Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
analyzed count
207
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00984282-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT00984282
outcome key
om-0000
arm key
OG001
arm label
Placebo
regimen
Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
analyzed count
210
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00984282-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT00984282
outcome key
om-0001
arm key
OG000
arm label
Sorafenib (Nexavar, BAY43-9006)
regimen
Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
analyzed count
207
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00984282-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT00984282
outcome key
om-0001
arm key
OG001
arm label
Placebo
regimen
Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
analyzed count
210
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00984282-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT00984282
outcome key
om-0002
arm key
OG000
arm label
Sorafenib (Nexavar, BAY43-9006)
regimen
Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
analyzed count
207
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00984282-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT00984282
outcome key
om-0002
arm key
OG001
arm label
Placebo
regimen
Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
analyzed count
210
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00984282-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT00984282
outcome key
om-0003
arm key
OG000
arm label
Sorafenib (Nexavar, BAY43-9006)
regimen
Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
analyzed count
196
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00984282-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT00984282
outcome key
om-0003
arm key
OG001
arm label
Placebo
regimen
Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
analyzed count
201
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00984282-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT00984282
outcome key
om-0004
arm key
OG000
arm label
Sorafenib (Nexavar, BAY43-9006)
regimen
Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
analyzed count
196
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00984282-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT00984282
outcome key
om-0004
arm key
OG001
arm label
Placebo
regimen
Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
analyzed count
201
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00984282-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT00984282
outcome key
om-0005
arm key
OG000
arm label
Sorafenib (Nexavar, BAY43-9006)
regimen
Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
analyzed count
24
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00984282-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT00984282
outcome key
om-0005
arm key
OG001
arm label
Placebo
regimen
Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00984282-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT00984282
harm key
EG000
source section id
NCT00984282-ae
event group key
EG000
event group label
Sorafenib (Double Blind Only)
serious affected
87
serious at risk
207
other affected
202
other at risk
207
frequency threshold
5
collection period
After signing the informed consent until the database cut-off 30 AUG 2017, study duration approximately eight years.
event definition
Abbreviations used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Cranial Nerve (CN), Range of Motion (ROM), Cerebrospinal Fluid (CSF), Genitourinary (GU).
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT00984282
harm key
EG001
source section id
NCT00984282-ae
event group key
EG001
event group label
Placebo (Double Blind Only)
serious affected
58
serious at risk
209
other affected
173
other at risk
209
frequency threshold
5
collection period
After signing the informed consent until the database cut-off 30 AUG 2017, study duration approximately eight years.
event definition
Abbreviations used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Cranial Nerve (CN), Range of Motion (ROM), Cerebrospinal Fluid (CSF), Genitourinary (GU).
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT00984282
harm key
EG002
source section id
NCT00984282-ae
event group key
EG002
event group label
Sorafenib, Open Label Only (Sorafenib Continued)
serious affected
51
serious at risk
86
other affected
74
other at risk
86
frequency threshold
5
collection period
After signing the informed consent until the database cut-off 30 AUG 2017, study duration approximately eight years.
event definition
Abbreviations used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Cranial Nerve (CN), Range of Motion (ROM), Cerebrospinal Fluid (CSF), Genitourinary (GU).
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT00984282
harm key
EG003
source section id
NCT00984282-ae
event group key
EG003
event group label
Placebo, Open Label Only (Switch to Sorafenib)
serious affected
96
serious at risk
161
other affected
159
other at risk
161
frequency threshold
5
collection period
After signing the informed consent until the database cut-off 30 AUG 2017, study duration approximately eight years.
event definition
Abbreviations used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Cranial Nerve (CN), Range of Motion (ROM), Cerebrospinal Fluid (CSF), Genitourinary (GU).
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice