Trial · NCT00381641
Sunitinib Malate in Treating Patients With Thyroid Cancer That Did Not Respond to Iodine I 131 and Cannot Be Removed by Surgery
NCT00381641, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2017-09-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Sunitinib Malate in Treating Patients With Thyroid Cancer That Did Not Respond to Iodine I 131 and Cannot Be Removed by Surgery. Trials, record NCT00381641. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00381641
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sunitinib Malate in Treating Patients With Thyroid Cancer That Did Not Respond to Iodine I 131 and Cannot Be Removed by Surgery
- NCT number
- NCT00381641
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 63 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Differentiated Thyroid Gland Carcinoma, Recurrent Thyroid Gland Carcinoma, Refractory Thyroid Gland Carcinoma, Stage III Thyroid Gland Follicular Carcinoma AJCC v7, Stage III Thyroid Gland Medullary Carcinoma AJCC v7, Stage IV Thyroid Gland Follicular Carcinoma AJCC v7, Stage IV Thyroid Gland Medullary Carcinoma AJCC v7, Stage IV Thyroid Gland Papillary Carcinoma AJCC v7, Stage IVA Thyroid Gland Follicular Carcinoma AJCC v7, Stage IVA Thyroid Gland Medullary Carcinoma AJCC v7, Stage IVA Thyroid Gland Papillary Carcinoma AJCC v7, Stage IVB Thyroid Gland Follicular Carcinoma AJCC v7, Stage IVB Thyroid Gland Medullary Carcinoma AJCC v7, Stage IVB Thyroid Gland Papillary Carcinoma AJCC v7, Stage IVC Thyroid Gland Follicular Carcinoma AJCC v7, Stage IVC Thyroid Gland Medullary Carcinoma AJCC v7, Stage IVC Thyroid Gland Papillary Carcinoma AJCC v7, Thyroid Gland Oncocytic Carcinoma, Unresectable Thyroid Gland Carcinoma
- Interventions
- Laboratory Biomarker Analysis, Pharmacogenomic Study, Sunitinib, Sunitinib Malate
- First posted
- 2006-09-28
- Last updated
- 2025-03-28
- Results first posted
- 2017-09-15
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate, Assessed Using the Response Evaluation Criteria in Solid Tumors (RECIST) | Up to 2 years | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or 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 | Incidence of Toxicity, Graded According to the Common Terminology Criteria for Adverse Events Version 3.0 | From time of first treatment with sunitinib, assessed up to 2 years | Any grade toxicity of any type, regardless of attribution |
| Secondary | Overall Survival | Up to 10 years | Kaplan-Meier curves will be generated and 95% confidence intervals will be derived for median overall survival. |
| Secondary | Time to Progression or Death Evaluated Using the RECIST | Time from start of treatment to time of progression or death of any cause, assessed up to 10 years | |
| Other | Changes in Laboratory Correlates Analyzed Using Paired T-tests | Baseline to 2 years | Relevant laboratory correlates will be compared between responders and non-responders using the Wilcoxon rank sum test. The association between the presence or absence of RET gene rearrangements/mutations and tumor response, as well as the association between germ-line polymorphisms in the RET gene and response, will be analyzed using Fisher's exact test. The correlative and genetic data will also be entered as covariates (univariate analyses only due to the small sample size) in a Cox regression model of progression-free survival. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate, Assessed Using the Response Evaluation Criteria in Solid Tumors (RECIST) | Up to 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Incidence of Toxicity, Graded According to the Common Terminology Criteria for Adverse Events Version 3.0 | From time of first treatment with sunitinib, assessed up to 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Survival | Up to 10 years | Months | MEDIAN | |
| SECONDARY | Time to Progression or Death Evaluated Using the RECIST | Time from start of treatment to time of progression or death of any cause, assessed up to 10 years | Months | MEDIAN | |
| OTHER_PRE_SPECIFIED | Changes in Laboratory Correlates Analyzed Using Paired T-tests | Baseline to 2 years |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate, Assessed Using the Response Evaluation Criteria in Solid Tumors (RECIST) | Sunitinib Malate-Radioactive Iodine Refractory Subgroup | 9 | Participants | ||
| Objective Response Rate, Assessed Using the Response Evaluation Criteria in Solid Tumors (RECIST) | Sunitinib Malate-Metastatic Medullary Subgroup | 7 | Participants | ||
| Incidence of Toxicity, Graded According to the Common Terminology Criteria for Adverse Events Version 3.0 | Sunitinib Malate-Radioactive Iodine Refractory Subgroup | 38 | Participants | ||
| Incidence of Toxicity, Graded According to the Common Terminology Criteria for Adverse Events Version 3.0 | Sunitinib Malate-Metastatic Medullary Subgroup | 24 | Participants | ||
| Overall Survival | Sunitinib Malate-Radioactive Iodine Refractory Subgroup | 32.6 | 95% Confidence Interval 18.4 to 70.9 | Months | |
| Overall Survival | Sunitinib Malate-Metastatic Medullary Subgroup | 65.4 | 95% Confidence Interval 27.0 to 69.5 | Months | |
| Time to Progression or Death Evaluated Using the RECIST | Sunitinib Malate-Radioactive Iodine Refractory Subgroup | 12.8 | 95% Confidence Interval 8.3 to 16.4 | Months | |
| Time to Progression or Death Evaluated Using the RECIST | Sunitinib Malate-Metastatic Medullary Subgroup | 19.3 | 95% Confidence Interval 7.7 to 34.6 | Months |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sunitinib Malate-Radioactive Iodine Refractory Subgroup | 38 | |
| Overall Study | STARTED | Sunitinib Malate-Metastatic Medullary Subgroup | 25 | |
| Overall Study | COMPLETED | Sunitinib Malate-Radioactive Iodine Refractory Subgroup | 38 | |
| Overall Study | COMPLETED | Sunitinib Malate-Metastatic Medullary Subgroup | 23 | |
| Overall Study | NOT COMPLETED | Sunitinib Malate-Radioactive Iodine Refractory Subgroup | 0 | |
| Overall Study | NOT COMPLETED | Sunitinib Malate-Metastatic Medullary Subgroup | 2 |
Source ClinicalTrials.gov
Adverse events258
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 | Abdominal pain | Gastrointestinal disorders | Sunitinib Malate-Radioactive Iodine Refractory Subgroup | 4 | 38 | |
| other | Abdominal pain | Gastrointestinal disorders | Sunitinib Malate-Metastatic Medullary Subgroup | 5 | 25 | |
| other | Alanine aminotransferase increased | Investigations | Sunitinib Malate-Radioactive Iodine Refractory Subgroup | 14 | 38 | |
| other | Alanine aminotransferase increased | Investigations | Sunitinib Malate-Metastatic Medullary Subgroup | 6 | 25 | |
| other | Alkaline phosphatase increased | Investigations | Sunitinib Malate-Radioactive Iodine Refractory Subgroup | 8 | 38 | |
| other | Alkaline phosphatase increased | Investigations | Sunitinib Malate-Metastatic Medullary Subgroup | 4 | 25 | |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Sunitinib Malate-Radioactive Iodine Refractory Subgroup | 4 | 38 | |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Sunitinib Malate-Metastatic Medullary Subgroup | 0 | 25 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Sunitinib Malate-Radioactive Iodine Refractory Subgroup | 3 | 38 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Sunitinib Malate-Metastatic Medullary Subgroup | 7 | 25 |
1 to 10 of 258Source ClinicalTrials.gov
See all 258 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sunitinib Malate-Radioactive Iodine Refractory Subgroup | 21 | 38 |
| Total, all-cause mortality | Sunitinib Malate-Metastatic Medullary Subgroup | 5 | 25 |
| Total, other adverse events | Sunitinib Malate-Radioactive Iodine Refractory Subgroup | 38 | 38 |
| Total, other adverse events | Sunitinib Malate-Metastatic Medullary Subgroup | 24 | 25 |
| Total, serious adverse events | Sunitinib Malate-Radioactive Iodine Refractory Subgroup | 17 | 38 |
| Total, serious adverse events | Sunitinib Malate-Metastatic Medullary Subgroup | 12 | 25 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA014599 | Cancer Center Support Grant | ODUNSI, KUNLE | UNIVERSITY OF CHICAGO | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Sunitinib Malate-Radioactive Iodine Refractory Subgroup vs Sunitinib Malate-Metastatic Medullary Subgroup: Objective Response Rate, Assessed Using the Response Evaluation Criteria in Solid Tumors (RECIST) | Trial comparisons |
Sunitinib Malate-Radioactive Iodine Refractory Subgroup vs Sunitinib Malate-Metastatic Medullary Subgroup: Incidence of Toxicity, Graded According to the Common Terminology Criteria for Adverse Events Version 3.0 | Trial comparisons |
| Sunitinib Malate-Radioactive Iodine Refractory Subgroup vs Sunitinib Malate-Metastatic Medullary Subgroup: deaths from any cause | Trial comparisons |
| Sunitinib Malate-Radioactive Iodine Refractory Subgroup vs Sunitinib Malate-Metastatic Medullary Subgroup: serious adverse events | Trial comparisons |
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/NCT00381641
GET https://conductscience.org/api/trials/v1/NCT00381641/events?page=2