Trial · NCT02393690
Iodine I-131 With or Without Selumetinib in Treating Patients With Recurrent or Metastatic Thyroid Cancer
NCT02393690, Phase 2, Completed, Academic and Community Cancer Research United; results first posted 2021-08-03
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Iodine I-131 With or Without Selumetinib in Treating Patients With Recurrent or Metastatic Thyroid Cancer. Trials, record NCT02393690. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02393690
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Iodine I-131 With or Without Selumetinib in Treating Patients With Recurrent or Metastatic Thyroid Cancer
- NCT number
- NCT02393690
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 60 participants, actual
- Lead sponsor
- Academic and Community Cancer Research United
- Conditions
Metastatic Thyroid Gland Carcinoma, Poorly Differentiated Thyroid Gland Carcinoma, Recurrent Thyroid Gland Carcinoma, Stage IV Thyroid Gland Follicular Carcinoma AJCC v7, Stage IV Thyroid Gland Papillary Carcinoma AJCC v7, Stage IVA Thyroid Gland Follicular Carcinoma AJCC v7, Stage IVA Thyroid Gland Papillary Carcinoma AJCC v7, Stage IVB Thyroid Gland Follicular Carcinoma AJCC v7, Stage IVB Thyroid Gland Papillary Carcinoma AJCC v7, Stage IVC Thyroid Gland Follicular Carcinoma AJCC v7, Stage IVC Thyroid Gland Papillary Carcinoma AJCC v7
- Interventions
- Iodine I-131, Placebo Administration, Selumetinib
- First posted
- 2015-03-19
- Last updated
- 2024-07-26
- Results first posted
- 2021-08-03
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response at 6 Months | At 6 months | A patient will be classified as a responder if they have a partial or complete response at the 6-month time point when compared to the baseline, pre-study radiologic scan(s). A Complete Response (CR) is defined as the disappearance of all target lesions and thyroglobulin measured to be less than 0.2 ng/ml. A Partial Response (PR) is defined as at least a 30% decrease in PBSD (sum of the longest diameter for all target lesions plus the sum of the long or short axis of all the target lymph nodes (depending on which axis is being used for assessments) at current evaluation) taking as reference the baseline sum of dimensions (BSD). \> \> A patient will be classified as a responder if they have a partial or complete response at the 6-month time point. The proportion of patients with a response will be calculated and compared between the 2 Arms using a Fisher's Exact test. |
| Secondary | Overall Response Rate | 2 years | The best overall response rate will be compared between the two arms. This comparison will be done using a Fisher exact test. For a patient to be classified as a response, they need a partial or complete response that is confirmed at least 4 weeks later anytime during the study. |
| Secondary | Progression Free Survival (PFS) | 2 years | PFS will be estimated using the Kaplan-Meier method, where the log-rank test will be used to compare the 2 treatment arms. |
| Secondary | Changes in Serum Thyroglobulin Levels | 6 months | Changes in serum thyroglobulin levels will be compared between the 2 treatment arms by 6 month response using the Wilcoxon Rank-Sum test. |
| Secondary | Incidence of Adverse Events | 2 years | The maximum grade for each type of adverse event will be summarized using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The number and percentage of patients experiencing grade 3+ adverse events will be compared between the 2 treatment arms. |
| Other | Genomic and Transcriptomic Landscape of Radioactive Iodine-avid (RAIA) Tumors | Baseline | Will explore the genomic and transcriptomic landscape of RAIA tumors for signatures that correlate to therapeutic benefit achieved in patients with RAI-avid recurrent and/or metastatic thyroid cancer treated with 131I in combination with placebo or selumetinib. Exploratory analysis will include correlating response to tumor genotypes. Descriptive statistics and graphical techniques will be used to summarize this data by treatment arm. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response at 6 Months | At 6 months | All patients that began protocol treatment and were evaluable for this endpoint are included. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Response Rate | 2 years | All patients that began protocol treatment and were evaluable for this endpoint are included. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression Free Survival (PFS) | 2 years | All patients that began protocol treatment and were evaluable for this endpoint are included. | months | MEDIAN |
| SECONDARY | Changes in Serum Thyroglobulin Levels | 6 months | All patients that began protocol treatment and were evaluable for this endpoint are included. | percent change from baseline | MEAN |
| SECONDARY | Incidence of Adverse Events | 2 years | All patients that began protocol treatment and were evaluable for this endpoint are included. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Genomic and Transcriptomic Landscape of Radioactive Iodine-avid (RAIA) Tumors | Baseline |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response at 6 Months | Arm I (Selumetinib, Iodine I-131) | 7 | Participants | ||
| Response at 6 Months | Arm II (Placebo, Iodine I-131) | 2 | Participants | ||
| Overall Response Rate | Arm I (Selumetinib, Iodine I-131) | 7 | Participants | ||
| Overall Response Rate | Arm II (Placebo, Iodine I-131) | 2 | Participants | ||
| Progression Free Survival (PFS) | Arm I (Selumetinib, Iodine I-131) | 19 | 95% Confidence Interval 12.4 to NA | months | |
| Progression Free Survival (PFS) | Arm II (Placebo, Iodine I-131) | 10.2 | 95% Confidence Interval 6.8 to NA | months | |
| Changes in Serum Thyroglobulin Levels | Arm I (Selumetinib, Iodine I-131) | -29.1 | Standard Deviation 50.36 | percent change from baseline | |
| Changes in Serum Thyroglobulin Levels | Arm II (Placebo, Iodine I-131) | 4.3 | Standard Deviation 61.28 | percent change from baseline | |
| Incidence of Adverse Events | Arm I (Selumetinib, Iodine I-131) | 6 | Participants | ||
| Incidence of Adverse Events | Arm II (Placebo, Iodine I-131) | 1 | Participants |
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 | Arm I (Selumetinib, Iodine I-131) | 28 | |
| Overall Study | STARTED | Arm II (Placebo, Iodine I-131) | 30 | |
| Overall Study | COMPLETED | Arm I (Selumetinib, Iodine I-131) | 28 | |
| Overall Study | COMPLETED | Arm II (Placebo, Iodine I-131) | 29 | |
| Overall Study | NOT COMPLETED | Arm I (Selumetinib, Iodine I-131) | 0 | |
| Overall Study | NOT COMPLETED | Arm II (Placebo, Iodine I-131) | 1 |
Source ClinicalTrials.gov
Adverse events84
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 | Anemia | Blood and lymphatic system disorders | Arm I (Selumetinib, Iodine I-131) | 1 | 28 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Arm II (Placebo, Iodine I-131) | 1 | 30 | 1 |
| other | Blurred vision | Eye disorders | Arm I (Selumetinib, Iodine I-131) | 7 | 28 | 11 |
| other | Blurred vision | Eye disorders | Arm II (Placebo, Iodine I-131) | 3 | 30 | 5 |
| other | Retinopathy | Eye disorders | Arm I (Selumetinib, Iodine I-131) | 1 | 28 | 2 |
| other | Retinopathy | Eye disorders | Arm II (Placebo, Iodine I-131) | 0 | 30 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Arm I (Selumetinib, Iodine I-131) | 1 | 28 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Arm II (Placebo, Iodine I-131) | 1 | 30 | 1 |
| other | Bloating | Gastrointestinal disorders | Arm I (Selumetinib, Iodine I-131) | 1 | 28 | 1 |
| other | Bloating | Gastrointestinal disorders | Arm II (Placebo, Iodine I-131) | 0 | 30 | 0 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Selumetinib, Iodine I-131) | 0 | 28 |
| Total, all-cause mortality | Arm II (Placebo, Iodine I-131) | 0 | 30 |
| Total, other adverse events | Arm I (Selumetinib, Iodine I-131) | 28 | 28 |
| Total, other adverse events | Arm II (Placebo, Iodine I-131) | 28 | 30 |
| Total, serious adverse events | Arm I (Selumetinib, Iodine I-131) | 2 | 28 |
| Total, serious adverse events | Arm II (Placebo, Iodine I-131) | 1 | 30 |
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 |
|---|---|---|---|---|---|
| P30CA015083 | Mayo Clinic Comprehensive Cancer Center Support Grant | WILLMAN, CHERYL LYNN | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm I (Selumetinib, Iodine I-131) vs Arm II (Placebo, Iodine I-131): Incidence of Adverse Events | Trial comparisons |
| Arm I (Selumetinib, Iodine I-131) vs Arm II (Placebo, Iodine I-131): Response at 6 Months | Trial comparisons |
| Arm I (Selumetinib, Iodine I-131) vs Arm II (Placebo, Iodine I-131): Overall Response Rate | Trial comparisons |
| Arm I (Selumetinib, Iodine I-131) vs Arm II (Placebo, Iodine I-131): deaths from any cause | Trial comparisons |
| Arm I (Selumetinib, Iodine I-131) vs Arm II (Placebo, Iodine I-131): 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/NCT02393690
GET https://conductscience.org/api/trials/v1/NCT02393690/events?page=2