Trial · NCT00984282
Nexavar® Versus Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer
NCT00984282, Phase 3, Completed, Bayer; results first posted 2013-12-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Nexavar® Versus Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer. Trials, record NCT00984282. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00984282
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nexavar® Versus Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer
- NCT number
- NCT00984282
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 417 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Thyroid Neoplasms
- Interventions
- Sorafenib (Nexavar, BAY43-9006), Placebo
- First posted
- 2009-09-25
- Last updated
- 2018-09-13
- Other registries' IDs
- eudract:2009-012007-25
- Results first posted
- 2013-12-10
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) Based on Central Assessment Incl. Clinical Progression Due to Bone Irradiation | Final analysis to be performed when approximately 267 progression-free survival events (centrally assessed) had occurred, study duration approximately three years | 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. |
| Secondary | Overall Survival (OS) | From randomization of the first subject until the database cut-off (30 AUG 2017), study duration approximately eight years | 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. |
| Secondary | Time to Progression (TTP) Based on Central Assessment Incl. Clinical Progression Due to Bone Irradiation | From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years | Time to progression was defined at the time (days) from randomization to progression (based on central assessment \[radiological and clinical progression due to bone irradiation\]) |
| Secondary | Disease Control Rate (DCR) Based on Central Assessment | From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years | 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. |
| Secondary | Response Rate Based on Central Assessment | From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years | 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. |
| Secondary | Duration of Response (DOR) Based on Central Assessment | From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years | 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. |
| Secondary | Maximum Percent Reduction in Target Lesion Size Based on Central Assessment | From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years | The magnitude of change from baseline in target lesion size in evaluable participants with scans was determined. |
| Secondary | AUC(0-12h),ss (Area Under the Concentration Time Curve From Time 0 to 12 Hours at Steady State) | A single pharmacokinetic plasma sample was collected at steady state (after 14 days of uninterrupted, unmodified sorafenib dosing) | Sorafenib AUC(0-12h),ss (area under the concentration time curve from time 0 to 12 hours at steady state) was estimated from the steady state plasma concentration. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) Based on Central Assessment Incl. Clinical Progression Due to Bone Irradiation | Final analysis to be performed when approximately 267 progression-free survival events (centrally assessed) had occurred, study duration approximately three years | 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. | Days | MEDIAN |
| SECONDARY | Overall Survival (OS) | From randomization of the first subject until the database cut-off (30 AUG 2017), study duration approximately eight years | Full Analysis Set (FAS) | Percentage of participants | NUMBER |
| SECONDARY | Time to Progression (TTP) Based on Central Assessment Incl. Clinical Progression Due to Bone Irradiation | From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years | FAS | Days | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) Based on Central Assessment | From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years | 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. | Percentage of participants | NUMBER |
| SECONDARY | Response Rate Based on Central Assessment | From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years | PPS | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) Based on Central Assessment | From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years | FAS - responders only | Days | MEDIAN |
| SECONDARY | Maximum Percent Reduction in Target Lesion Size Based on Central Assessment | From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years | PPS | Percentage of participants | NUMBER |
| SECONDARY | AUC(0-12h),ss (Area Under the Concentration Time Curve From Time 0 to 12 Hours at Steady State) | A single pharmacokinetic plasma sample was collected at steady state (after 14 days of uninterrupted, unmodified sorafenib dosing) | Pharmacokinetic (PK) analysis set=participants with PK data collected after 14 days of uninterrupted and unmodified dosing of sorafenib. If an interruption occurred within 14 days prior to the sample, no doses may be missed for 3 days prior to the sample, and no more than 3 doses could be missed 4 to 14 days prior to the sample collection date. | mg*h/L | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group25
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) Based on Central Assessment Incl. Clinical Progression Due to Bone Irradiation | Sorafenib (Nexavar, BAY43-9006) | 329 | 95% Confidence Interval 278 to 393 | Days | |
| Progression-free Survival (PFS) Based on Central Assessment Incl. Clinical Progression Due to Bone Irradiation | Placebo | 175 | 95% Confidence Interval 160 to 238 | Days | |
| Overall Survival (OS) | Sorafenib (Nexavar, BAY43-9006) | 52.7 | Percentage of participants | ||
| Overall Survival (OS) | Placebo | 54.8 | Percentage of participants | ||
| Time to Progression (TTP) Based on Central Assessment Incl. Clinical Progression Due to Bone Irradiation | Sorafenib (Nexavar, BAY43-9006) | 337 | 95% Confidence Interval 283 to 451 | Days | |
| Time to Progression (TTP) Based on Central Assessment Incl. Clinical Progression Due to Bone Irradiation | Placebo | 175 | 95% Confidence Interval 160 to 238 | Days | |
| Disease Control Rate (DCR) Based on Central Assessment | Sorafenib (Nexavar, BAY43-9006) | 86.2 | 95% Confidence Interval 80.6 to 90.7 | Percentage of participants | |
| Disease Control Rate (DCR) Based on Central Assessment | Placebo | 74.6 | 95% Confidence Interval 68.0 to 80.5 | Percentage of participants | |
| Response Rate Based on Central Assessment | Sorafenib (Nexavar, BAY43-9006) | 12.24 | 95% Confidence Interval 8.01 to 17.67 | Percentage of participants | |
| Response Rate Based on Central Assessment | Placebo | 0.5 | 95% Confidence Interval 0.01 to 2.74 | Percentage of participants |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 results by groupParticipant flow22
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double Blind Treatment | STARTED | DB Sorafenib First, Then Option of OL Sorafenib Treatment | 207 | |
| Double Blind Treatment | STARTED | DB Placebo First, Then Option of OL Sorafenib Treatment | 210 | |
| Double Blind Treatment | Received Treatment | DB Sorafenib First, Then Option of OL Sorafenib Treatment | 207 | |
| Double Blind Treatment | Received Treatment | DB Placebo First, Then Option of OL Sorafenib Treatment | 209 | |
| Double Blind Treatment | COMPLETED | DB Sorafenib First, Then Option of OL Sorafenib Treatment | 103 | |
| Double Blind Treatment | COMPLETED | DB Placebo First, Then Option of OL Sorafenib Treatment | 172 | |
| Double Blind Treatment | NOT COMPLETED | DB Sorafenib First, Then Option of OL Sorafenib Treatment | 104 | |
| Double Blind Treatment | NOT COMPLETED | DB Placebo First, Then Option of OL Sorafenib Treatment | 38 | |
| Open-label Treatment | STARTED | DB Sorafenib First, Then Option of OL Sorafenib Treatment | 86 | |
| Open-label Treatment | STARTED | DB Placebo First, Then Option of OL Sorafenib Treatment | 161 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 participant flowAdverse events932
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Blood - Other | Blood and lymphatic system disorders | Sorafenib (Double Blind Only) | 6 | 207 | 6 |
| other | Blood - Other | Blood and lymphatic system disorders | Placebo (Double Blind Only) | 6 | 209 | 10 |
| other | Blood - Other | Blood and lymphatic system disorders | Sorafenib, Open Label Only (Sorafenib Continued) | 6 | 86 | 20 |
| other | Blood - Other | Blood and lymphatic system disorders | Placebo, Open Label Only (Switch to Sorafenib) | 10 | 161 | 23 |
| other | Edema: Limb | Blood and lymphatic system disorders | Sorafenib (Double Blind Only) | 13 | 207 | 17 |
| other | Edema: Limb | Blood and lymphatic system disorders | Placebo (Double Blind Only) | 6 | 209 | 7 |
| other | Edema: Limb | Blood and lymphatic system disorders | Sorafenib, Open Label Only (Sorafenib Continued) | 8 | 86 | 9 |
| other | Edema: Limb | Blood and lymphatic system disorders | Placebo, Open Label Only (Switch to Sorafenib) | 8 | 161 | 11 |
| other | Hemoglobin | Blood and lymphatic system disorders | Sorafenib (Double Blind Only) | 18 | 207 | 24 |
| other | Hemoglobin | Blood and lymphatic system disorders | Placebo (Double Blind Only) | 10 | 209 | 11 |
1 to 10 of 932Source ClinicalTrials.gov
See all 932 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sorafenib (Double Blind Only) | 71 | 207 |
| Total, all-cause mortality | Placebo (Double Blind Only) | 25 | 209 |
| Total, all-cause mortality | Sorafenib, Open Label Only (Sorafenib Continued) | 38 | 86 |
| Total, all-cause mortality | Placebo, Open Label Only (Switch to Sorafenib) | 90 | 161 |
| Total, other adverse events | Sorafenib (Double Blind Only) | 202 | 207 |
| Total, other adverse events | Placebo (Double Blind Only) | 173 | 209 |
| Total, other adverse events | Sorafenib, Open Label Only (Sorafenib Continued) | 74 | 86 |
| Total, other adverse events | Placebo, Open Label Only (Switch to Sorafenib) | 159 | 161 |
| Total, serious adverse events | Sorafenib (Double Blind Only) | 87 | 207 |
| Total, serious adverse events | Placebo (Double Blind Only) | 58 | 209 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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