Trial · NCT02152995
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| 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. |
| Secondary | Number of Participants With Toxicity (Cohort B) | Up to 30 days after completion of treatment | Will be assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0. Toxicities will be individually reported and summarized. Beginning April 1, 2018, CTCAE v5.0 will be utilized for adverse event (AE) reporting. |
| Other | Expression and Phosphorylation of MAPK Signaling Pathway Proteins | Up to 6 months | Analyses will be descriptive. |
| Other | Expression and Phosphorylation of Negative Feedback Loops Connected to the MAPK Pathway (Such as Human Epidermal Growth Factor 3) | Up to 6 months | Analyses will be descriptive. |
| Other | Quantitative Levels of Messenger Ribonucleic Acid Transcripts for MAPK Regulated and Thyroid-specific Gene Products | Up to 6 months | Analyses will be descriptive. |
| Other | Presence of Other Genetic Alterations | Up to 6 months | Analyses will be descriptive. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT02152995/registered