Trial · NCT02152995
Trametinib in Increasing Tumoral Iodine Incorporation in Patients With Recurrent or Metastatic Thyroid Cancer
NCT02152995, Phase 2, Active not recruiting, National Cancer Institute (NCI); results first posted 2022-12-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trametinib in Increasing Tumoral Iodine Incorporation in Patients With Recurrent or Metastatic Thyroid Cancer. Trials, record NCT02152995. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02152995
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trametinib in Increasing Tumoral Iodine Incorporation in Patients With Recurrent or Metastatic Thyroid Cancer
- NCT number
- NCT02152995
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 34 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Metastatic Thyroid Gland Carcinoma, Poorly Differentiated Thyroid Gland Carcinoma, Recurrent Thyroid Gland Carcinoma, Refractory 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
- Computed Tomography, Iodine I 124, Iodine I-131, Laboratory Biomarker Analysis, Pharmacodynamic Study, Positron Emission Tomography, Trametinib
- First posted
- 2014-06-02
- Last updated
- 2026-08-28
- Results first posted
- 2022-12-28
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients Progression Free at 6 Months Following Treatment With Trametinib and I-124 (Cohort A) | At 6 months | Cohort A only. 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 |
| Primary | Progression Free Survival (Cohort A) | At 6 months | An exact binomial stage design will be used to discriminate between true 6-month progression/death rates of 20% vs 50%, and between true ORR rates at 6 months of 5% and 25%. 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 |
| Primary | Percentage With Objective Response (Complete Response or Partial Response) (Cohort A) | At 6 months | Will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. An exact binomial stage design will be used to discriminate between true 6-month ORR rates at 6 months of 5% and 25%. 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. |
| Primary | Iodine Incorporation in Thyroid Cancer Metastases to a Predicted Lesional Absorbed Radiation Dose Equal to or Exceeding 2,000 cGy With the Administration of =< 300 mCi Radioiodine (RAI) (Cohort B) | Up to 6 months | "Adequate increase" is defined as increasing iodine incorporation in thyroid cancer metastases to a predicted lesional absorbed radiation dose equal to or exceeding 2,000 cGy with the administration of \< 300 mCi RAI. Iodine incorporation is quantified with PET/CT lesional dosimetry. |
| Secondary | Adequate Increase in Iodine Corporation (Cohort A) | Up to 6 months | Will be determined by treatment with trametinib in thyroid cancer metastases to a predicted lesional absorbed radiation dose equal to or exceeding 2,000 cGy with the administration of =\< 300 mCi radioiodine (RAI). Proportion of patients with an adequate increase will be reported, along with the corresponding exact 95% confidence interval. |
| Secondary | Changes in Thyroglobulin | Baseline to up to 6 months | Wilcoxon signed rank test will be performed for paired samples to compare the thyroglobulin level before and after RAI treatment in the subset of patients treated with RAI. |
| Secondary | Number of Participants With Toxicity (Cohort A) | Up to 30 days after completion of treatment | Will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Toxicities will be individually reported and summarized. |
| Secondary | Percentage With an Objective Response (Complete Response or Partial Response) (Cohort B) | At 6 months | Will be assessed by RECIST v1 1.1 criteria. An exact binomial stage design will be used to discriminate between true 6-month ORR rates at 6 months of 5% and 25%. |
| Secondary | Percentage of Patients Alive Without Disease Progression (Cohort B) | At 6 months | Assessed per RECIST v1.1. Will be estimated using 95% confidence intervals. |
| Secondary | Change in Thyroglobulin (Cohort B) | Baseline up to 6 months | Will determine whether treatment with trametinib and RAI results in decreasing thyroglobulin. Will perform a Wilcoxon signed rank test for paired samples to compare the thyroglobulin level before and after RAI treatment in the subset of patients treated with RAI. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients Progression Free at 6 Months Following Treatment With Trametinib and I-124 (Cohort A) | At 6 months | % of pts progression free at 6 months | NUMBER | |
| PRIMARY | Progression Free Survival (Cohort A) | At 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Percentage With Objective Response (Complete Response or Partial Response) (Cohort A) | At 6 months | % of pts with confirmed partial response | NUMBER | |
| PRIMARY | Iodine Incorporation in Thyroid Cancer Metastases to a Predicted Lesional Absorbed Radiation Dose Equal to or Exceeding 2,000 cGy With the Administration of =< 300 mCi Radioiodine (RAI) (Cohort B) | Up to 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Adequate Increase in Iodine Corporation (Cohort A) | Up to 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Changes in Thyroglobulin | Baseline to up to 6 months | Data were not collected | ||
| SECONDARY | Number of Participants With Toxicity (Cohort A) | Up to 30 days after completion of treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage With an Objective Response (Complete Response or Partial Response) (Cohort B) | At 6 months | % of pts with confirmed partial response | NUMBER | |
| SECONDARY | Percentage of Patients Alive Without Disease Progression (Cohort B) | At 6 months | % of pts progression free at 6 months | NUMBER | |
| SECONDARY | Change in Thyroglobulin (Cohort B) | Baseline up to 6 months | Data were not collected |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients Progression Free at 6 Months Following Treatment With Trametinib and I-124 (Cohort A) | Cohort A (Iodine I-124 PET/CT, Trametinib, Iodine I-131) | 44 | % of pts progression free at 6 months | ||
| Progression Free Survival (Cohort A) | Cohort A (Iodine I-124 PET/CT, Trametinib, Iodine I-131) | Pts progression-free at 6 months | 11 | Participants | |
| Progression Free Survival (Cohort A) | Cohort A (Iodine I-124 PET/CT, Trametinib, Iodine I-131) | Pts who were not progression-free at 6 months | 14 | Participants | |
| Percentage With Objective Response (Complete Response or Partial Response) (Cohort A) | Cohort A (Iodine I-124 PET/CT, Trametinib, Iodine I-131) | 32 | % of pts with confirmed partial response | ||
| Iodine Incorporation in Thyroid Cancer Metastases to a Predicted Lesional Absorbed Radiation Dose Equal to or Exceeding 2,000 cGy With the Administration of =< 300 mCi Radioiodine (RAI) (Cohort B) | Cohort B (Iodine I-124 PET/CT, Trametinib, Iodine I-131) | Pts who met the lesional dosimetry threshold for I-131 therapy | 4 | Participants | |
| Iodine Incorporation in Thyroid Cancer Metastases to a Predicted Lesional Absorbed Radiation Dose Equal to or Exceeding 2,000 cGy With the Administration of =< 300 mCi Radioiodine (RAI) (Cohort B) | Cohort B (Iodine I-124 PET/CT, Trametinib, Iodine I-131) | Pts who did not meet the lesional dosimetry threshold for I-131 therapy | 5 | Participants | |
| Adequate Increase in Iodine Corporation (Cohort A) | Cohort A (Iodine I-124 PET/CT, Trametinib, Iodine I-131) | Pts who met the lesional dosimetry threshold for I-131 therapy | 15 | Participants | |
| Adequate Increase in Iodine Corporation (Cohort A) | Cohort A (Iodine I-124 PET/CT, Trametinib, Iodine I-131) | Pts who did not meet the lesional dosimetry threshold for I-131 therapy | 10 | Participants | |
| Number of Participants With Toxicity (Cohort A) | Cohort A (Iodine I-124 PET/CT, Trametinib, Iodine I-131) | 25 | Participants | ||
| Percentage With an Objective Response (Complete Response or Partial Response) (Cohort B) | Cohort B (Iodine I-124 PET/CT, Trametinib, Iodine I-131) | 11 | % of pts with confirmed partial response |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A (Iodine I-124 PET/CT, Trametinib, Iodine I-131) | 25 | |
| Overall Study | STARTED | Cohort B (Iodine I-124 PET/CT, Trametinib, Iodine I-131) | 9 | |
| Overall Study | Participants Who Continued Treatment With Trametinib Only | Cohort A (Iodine I-124 PET/CT, Trametinib, Iodine I-131) | 5 | |
| Overall Study | Participants Who Continued Treatment With Trametinib Only | Cohort B (Iodine I-124 PET/CT, Trametinib, Iodine I-131) | 2 | |
| Overall Study | COMPLETED | Cohort A (Iodine I-124 PET/CT, Trametinib, Iodine I-131) | 24 | |
| Overall Study | COMPLETED | Cohort B (Iodine I-124 PET/CT, Trametinib, Iodine I-131) | 9 | |
| Overall Study | NOT COMPLETED | Cohort A (Iodine I-124 PET/CT, Trametinib, Iodine I-131) | 1 | |
| Overall Study | NOT COMPLETED | Cohort B (Iodine I-124 PET/CT, Trametinib, Iodine I-131) | 0 |
Source ClinicalTrials.gov
Adverse events64
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 | Cohort A (Iodine I-124 PET/CT, Trametinib, Iodine I-131) | 1 | 25 | |
| other | Abdominal pain | Gastrointestinal disorders | Cohort B (Iodine I-124 PET/CT, Trametinib, Iodine I-131) | 2 | 9 | |
| other | Alanine aminotransferase increased | Investigations | Cohort A (Iodine I-124 PET/CT, Trametinib, Iodine I-131) | 7 | 25 | |
| other | Alanine aminotransferase increased | Investigations | Cohort B (Iodine I-124 PET/CT, Trametinib, Iodine I-131) | 0 | 9 | |
| other | Alkaline phosphatase increased | Investigations | Cohort A (Iodine I-124 PET/CT, Trametinib, Iodine I-131) | 4 | 25 | |
| other | Alkaline phosphatase increased | Investigations | Cohort B (Iodine I-124 PET/CT, Trametinib, Iodine I-131) | 0 | 9 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Cohort A (Iodine I-124 PET/CT, Trametinib, Iodine I-131) | 3 | 25 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Cohort B (Iodine I-124 PET/CT, Trametinib, Iodine I-131) | 0 | 9 | |
| other | Anemia | Blood and lymphatic system disorders | Cohort A (Iodine I-124 PET/CT, Trametinib, Iodine I-131) | 4 | 25 | |
| other | Anemia | Blood and lymphatic system disorders | Cohort B (Iodine I-124 PET/CT, Trametinib, Iodine I-131) | 1 | 9 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A (Iodine I-124 PET/CT, Trametinib, Iodine I-131) | 6 | 25 |
| Total, all-cause mortality | Cohort B (Iodine I-124 PET/CT, Trametinib, Iodine I-131) | 1 | 9 |
| Total, other adverse events | Cohort A (Iodine I-124 PET/CT, Trametinib, Iodine I-131) | 25 | 25 |
| Total, other adverse events | Cohort B (Iodine I-124 PET/CT, Trametinib, Iodine I-131) | 9 | 9 |
| Total, serious adverse events | Cohort A (Iodine I-124 PET/CT, Trametinib, Iodine I-131) | 6 | 25 |
| Total, serious adverse events | Cohort B (Iodine I-124 PET/CT, Trametinib, Iodine I-131) | 1 | 9 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants3
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 | Source |
|---|---|---|---|---|---|---|
| P30CA008748 | Cancer Center Support Grant | Rudin, Charles M. | SLOAN-KETTERING INST CAN RESEARCH | NATIONAL CANCER INSTITUTE | 1985 to 2026 | NIH RePORTER |
| P50CA172012 | SPORE in Thyroid Cancer | FAGIN, JAMES A | SLOAN-KETTERING INST CAN RESEARCH | NATIONAL CANCER INSTITUTE | 2014 to 2018 | NIH RePORTER |
| R01CA184724 | Targeting MEK to Restore Radioiodine Efficacy for RAI-Refractory Thyroid Cancer | HO, ALAN L. | SLOAN-KETTERING INST CAN RESEARCH | NATIONAL CANCER INSTITUTE | 2015 to 2017 | NIH RePORTER |
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort A (Iodine I-124 PET/CT, Trametinib, Iodine I-131) vs Cohort B (Iodine I-124 PET/CT, Trametinib, Iodine I-131): deaths from any cause | Trial comparisons |
| Cohort A (Iodine I-124 PET/CT, Trametinib, Iodine I-131) vs Cohort B (Iodine I-124 PET/CT, Trametinib, 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/NCT02152995
GET https://conductscience.org/api/trials/v1/NCT02152995/events?page=2