Trial · NCT01025453
Combination of Temsirolimus and Sorafenib in the Treatment of Radioactive Iodine Refractory Thyroid Cancer
NCT01025453, Phase 2, Completed, Memorial Sloan Kettering Cancer Center; results first posted 2018-08-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Combination of Temsirolimus and Sorafenib in the Treatment of Radioactive Iodine Refractory Thyroid Cancer. Trials, record NCT01025453. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01025453
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination of Temsirolimus and Sorafenib in the Treatment of Radioactive Iodine Refractory Thyroid Cancer
- NCT number
- NCT01025453
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 37 participants, actual
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Conditions
- Thyroid Cancer
- Interventions
- Temsirolimus and Sorafenib
- First posted
- 2009-12-03
- Last updated
- 2018-08-15
- Results first posted
- 2018-08-15
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Reponse Rate of the Combination Sorafenib and Temsirolimus in I-131 Refractory Thyroid Cancer. | 2 years | 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 | Duration of Study Treatment for Participants With and Without BRAF Mutations | 6 years | |
| Secondary | Percentage of Participants With Progression-free Survival Under the Combination Sorafenib and Temsirolimus in I-131 Refractory Thyroid Cancer. | 1 year | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions |
| Secondary | Safety and Tolerability for the Combination Sorafenib and Temsirolimus in I-131 Refractory Thyroid Cancer. | 3 years | Participant toxicities evaluated by CTCAE version 4.0 |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Reponse Rate of the Combination Sorafenib and Temsirolimus in I-131 Refractory Thyroid Cancer. | 2 years | 7 participants were not evaluable because they came off treatment before the first radiographic scan for reasons other than progression of disease, including but not limited to excessive toxicity (n=1), withdrawal of consent (n=3), and seeing other treatment (n=1). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Study Treatment for Participants With and Without BRAF Mutations | 6 years | The analysis separated the participants into 2 groups (number of patients with BRAF V600E Mutation and number of patients without BRAF V600E Mutation) | months | MEDIAN |
| SECONDARY | Percentage of Participants With Progression-free Survival Under the Combination Sorafenib and Temsirolimus in I-131 Refractory Thyroid Cancer. | 1 year | percentage of patients | NUMBER | |
| SECONDARY | Safety and Tolerability for the Combination Sorafenib and Temsirolimus in I-131 Refractory Thyroid Cancer. | 3 years | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Reponse Rate of the Combination Sorafenib and Temsirolimus in I-131 Refractory Thyroid Cancer. | Pts Getting Temsirolimus and Sorafenib | Partial Response | 8 | Participants | |
| Reponse Rate of the Combination Sorafenib and Temsirolimus in I-131 Refractory Thyroid Cancer. | Pts Getting Temsirolimus and Sorafenib | Stable Disease | 21 | Participants | |
| Reponse Rate of the Combination Sorafenib and Temsirolimus in I-131 Refractory Thyroid Cancer. | Pts Getting Temsirolimus and Sorafenib | Disease Progression | 1 | Participants | |
| Duration of Study Treatment for Participants With and Without BRAF Mutations | Pts Getting Temsirolimus and Sorafenib | Pts with BRAF V600E Mutation | 5.2 | Full Range 0.7 to 63 | months |
| Duration of Study Treatment for Participants With and Without BRAF Mutations | Pts Getting Temsirolimus and Sorafenib | Pts w/o BRAF V600E Mutation | 6.7 | Full Range 0.5 to 25.6 | months |
| Percentage of Participants With Progression-free Survival Under the Combination Sorafenib and Temsirolimus in I-131 Refractory Thyroid Cancer. | Pts Getting Temsirolimus and Sorafenib | 30.5 | percentage of patients | ||
| Safety and Tolerability for the Combination Sorafenib and Temsirolimus in I-131 Refractory Thyroid Cancer. | Pts Getting Temsirolimus and Sorafenib | 37 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pts Getting Temsirolimus and Sorafenib | 37 | |
| Overall Study | COMPLETED | Pts Getting Temsirolimus and Sorafenib | 37 | |
| Overall Study | NOT COMPLETED | Pts Getting Temsirolimus and Sorafenib | 0 |
Source ClinicalTrials.gov
Adverse events98
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 | Hyperglycemia | Metabolism and nutrition disorders | Pts Getting Temsirolimus and Sorafenib | 21 | 37 | |
| other | Platelet count decreased | Investigations | Pts Getting Temsirolimus and Sorafenib | 11 | 37 | |
| other | Fatigue | General disorders | Pts Getting Temsirolimus and Sorafenib | 14 | 37 | |
| other | Aspartate aminotransferase increased | Investigations | Pts Getting Temsirolimus and Sorafenib | 6 | 37 | |
| other | Diarrhea | Gastrointestinal disorders | Pts Getting Temsirolimus and Sorafenib | 11 | 37 | |
| other | Alanine aminotransferase increased | Investigations | Pts Getting Temsirolimus and Sorafenib | 8 | 37 | |
| other | Hypertriglyceridemia | Metabolism and nutrition disorders | Pts Getting Temsirolimus and Sorafenib | 6 | 37 | |
| other | Nausea | Gastrointestinal disorders | Pts Getting Temsirolimus and Sorafenib | 3 | 37 | |
| other | Anorexia | Metabolism and nutrition disorders | Pts Getting Temsirolimus and Sorafenib | 12 | 37 | |
| other | Hypertension | Vascular disorders | Pts Getting Temsirolimus and Sorafenib | 15 | 37 |
1 to 10 of 98Source ClinicalTrials.gov
See all 98 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pts Getting Temsirolimus and Sorafenib | 32 | 37 |
| Total, other adverse events | Pts Getting Temsirolimus and Sorafenib | 37 | 37 |
| Total, serious adverse events | Pts Getting Temsirolimus and Sorafenib | 23 | 37 |
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/NCT01025453
GET https://conductscience.org/api/trials/v1/NCT01025453/events?page=2