Trial · NCT00654238
Phase II Trial of Sorafenib (Nexavar) in Patients With Advanced Thyroid Cancer
NCT00654238, Phase 2, Completed, University of Pennsylvania; results first posted 2019-11-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase II Trial of Sorafenib (Nexavar) in Patients With Advanced Thyroid Cancer. Trials, record NCT00654238. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00654238
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Trial of Sorafenib (Nexavar) in Patients With Advanced Thyroid Cancer
- NCT number
- NCT00654238
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 59 participants, actual
- Lead sponsor
- University of Pennsylvania
- Conditions
- Metastatic Differentiated Thyroid Cancer, Metastatic Poorly Differentiated Thyroid Cancer, Metastatic Anaplastic Thyroid Cancer, Metastatic Medullary Thyroid Cancer
- Interventions
- sorafenib
- First posted
- 2008-04-07
- Last updated
- 2019-11-18
- Results first posted
- 2019-11-18
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To Determine the Efficacy (Best Response) of BAY 43-9006 (Objective Response Rate and Stable Disease) in Patients With Metastatic Thyroid Carcinoma. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Secondary | Median Progression Free Survival in Patients Receiving BAY 43-9006 (Sorafenib). | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months | This is the result of the Kaplan Meier analysis of all patients treated with sorafenib |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | To Determine the Efficacy (Best Response) of BAY 43-9006 (Objective Response Rate and Stable Disease) in Patients With Metastatic Thyroid Carcinoma. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months | Responses were calculated by total enrolled to each group by histologic subtype. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Median Progression Free Survival in Patients Receiving BAY 43-9006 (Sorafenib). | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months | Of the 59 patients that were consented, four patients were deemed ineligible as a result of inadequate CBC and the establishment of an alternative diagnosis resulting from secondary pathology review. Therefore the total number of patients analyzed going forward was 55. | weeks | MEDIAN |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| To Determine the Efficacy (Best Response) of BAY 43-9006 (Objective Response Rate and Stable Disease) in Patients With Metastatic Thyroid Carcinoma. | Sorafenib | Differentiated / Complete Response | 0 | Participants | |
| To Determine the Efficacy (Best Response) of BAY 43-9006 (Objective Response Rate and Stable Disease) in Patients With Metastatic Thyroid Carcinoma. | Sorafenib | Differentiated / Partial response | 16 | Participants | |
| To Determine the Efficacy (Best Response) of BAY 43-9006 (Objective Response Rate and Stable Disease) in Patients With Metastatic Thyroid Carcinoma. | Sorafenib | Differentiated / Stable Disease | 22 | Participants | |
| To Determine the Efficacy (Best Response) of BAY 43-9006 (Objective Response Rate and Stable Disease) in Patients With Metastatic Thyroid Carcinoma. | Sorafenib | Differentiated / Progressive Disease | 1 | Participants | |
| To Determine the Efficacy (Best Response) of BAY 43-9006 (Objective Response Rate and Stable Disease) in Patients With Metastatic Thyroid Carcinoma. | Sorafenib | Differentiated / Not Evaluable for Response | 5 | Participants | |
| To Determine the Efficacy (Best Response) of BAY 43-9006 (Objective Response Rate and Stable Disease) in Patients With Metastatic Thyroid Carcinoma. | Sorafenib | Poorly Differenitated / Complete Response | 0 | Participants | |
| To Determine the Efficacy (Best Response) of BAY 43-9006 (Objective Response Rate and Stable Disease) in Patients With Metastatic Thyroid Carcinoma. | Sorafenib | Poorly Differenitated / Partial response | 2 | Participants | |
| To Determine the Efficacy (Best Response) of BAY 43-9006 (Objective Response Rate and Stable Disease) in Patients With Metastatic Thyroid Carcinoma. | Sorafenib | Poorly Differenitated / Stable Disease | 1 | Participants | |
| To Determine the Efficacy (Best Response) of BAY 43-9006 (Objective Response Rate and Stable Disease) in Patients With Metastatic Thyroid Carcinoma. | Sorafenib | Poorly Differenitated / Progressive Disease | 1 | Participants | |
| To Determine the Efficacy (Best Response) of BAY 43-9006 (Objective Response Rate and Stable Disease) in Patients With Metastatic Thyroid Carcinoma. | Sorafenib | Poorly Differenitated / Not Evaluable for Response | 2 | Participants |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sorafenib | 59 | |
| Overall Study | COMPLETED | Sorafenib | 55 | |
| Overall Study | NOT COMPLETED | Sorafenib | 4 |
Source ClinicalTrials.gov
Adverse events14
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 | Hand Foot Skin Reaction | Skin and subcutaneous tissue disorders | Sorafenib | 43 | 55 | 43 |
| other | Rash | Skin and subcutaneous tissue disorders | Sorafenib | 41 | 55 | 41 |
| other | Diarrhea | Gastrointestinal disorders | Sorafenib | 29 | 55 | 29 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Sorafenib | 25 | 55 | 25 |
| other | Stomatitis/Mucositis | Gastrointestinal disorders | Sorafenib | 18 | 55 | 18 |
| other | Fatigue | General disorders | Sorafenib | 15 | 55 | 15 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Sorafenib | 11 | 55 | 11 |
| other | GI Discomfort | Gastrointestinal disorders | Sorafenib | 9 | 55 | 9 |
| other | Hypertension | Vascular disorders | Sorafenib | 8 | 55 | 8 |
| other | Squamous Cell Carcinoma of the Skin | Skin and subcutaneous tissue disorders | Sorafenib | 8 | 55 | 8 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sorafenib | 36 | 55 |
| Total, other adverse events | Sorafenib | 43 | 55 |
| Total, serious adverse events | Sorafenib | 4 | 55 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00654238
GET https://conductscience.org/api/trials/v1/NCT00654238/results?page=2