Trial · NCT03148275
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate | 6 months | Will be assessed by Response Evaluation Criteria in Solid Tumors version 1.1. A Simon minimax sampling two-stage design will be used to estimate the objective response rate. Will be calculated along with 95% confidence intervals. |
| Secondary | 6 Month Progression-free Survival | From time of first dose of study medication to occurrence of radiologic tumor progression per Response Evaluation Criteria in Solid Tumors 1.1, clinical progression based on treating physician assessment or death from any cause, assessed at 6 months | Will be calculated along with 95% confidence intervals and estimated by the Kaplan-Meier method. |
| Secondary | Overall Survival | From the time of first dose of study drug to occurrence of death from any cause, assessed at 2 years | Will be calculated along with 95% confidence intervals and estimated by the Kaplan-Meier method. |
| Secondary | Incidence of Adverse Events | at 6 months | Graded according to the National Cancer Institute Common Terminology Criteria of Adverse Events version 5.0. The rates of adverse events occurring in at least 5% of subjects and rates of grade 3-5 adverse events will be tabulated by system and term. |
| Secondary | Change in Patient Reported Symptoms | Baseline and at 6 months | Will be assessed by the National Institutes of Health Patient Reported Outcomes Measurement Information System questionnaire. Patient Reported Outcomes Measurement Information System questionnaires will be scored according to recommended standardized system and t-scores generated. A mixed model will be used to analyze change in t-scores over time. PROMIS questionnaires were scored according to recommended standardized system and T-scores. A Wilcoxon signed rank test was used to assess the change in scores/T-scores over time. Determination of change in score between timepoints only included patients that had scores at those timepoints. Pain Intensity - 3a Scale: 36.3 (no pain) - 81.8 (severe pain) Pain Interference - 4a Scale: 41.6 (no interference) - 75.6 (large interference) Pain Behavior - 7a Scale: 34.1 (had no pain) - 78.9 (always in pain) Global Mental Heath Scale: 21.2 (severe) - 67.6 (none) Global Mental Physical Scale: 16.2 (severe) - 67.7 (none) |
| Secondary | Median Progression-free Survival | From time of first dose of study medication to occurrence of radiologic tumor progression per Response Evaluation Criteria in Solid Tumors 1.1, clinical progression based on treating physician | Will be calculated along with 95% confidence intervals and estimated by the Kaplan-Meier method. |
| Other | Change in Epithelioid Hemangioendothelioma Growth Rate | Baseline up to 6 months | McNemar test will be used to compare the number of patients with epithelioid hemangioendothelioma progression prior to starting trametinib to the number of patients with epithelioid hemangioendothelioma progression during treatment. |
| Other | Change in CRP Level | Baseline up to 6 months | Will be used as time-dependent variables in a Cox model to determine the association with epithelioid hemangioendothelioma survival. |
| Other | Change in ESR Level | Baseline up to 6 months | Will be used as time-dependent variables in a Cox model to determine the association with epithelioid hemangioendothelioma survival. |
| Other | Change in Plasma CTGF Level | Baseline up to 6 months | Will be analyzed by enzyme-linked immunosorbent assay. Will be used as time-dependent variables in a Cox model to determine the association with epithelioid hemangioendothelioma survival. |
| Other | Change in Tumor Volume | Baseline up to 6 months | Will be assessed by Response Evaluation Criteria in Solid Tumors version 1.1. Will be summarized with a scatterplot. The Pearson correlation coefficient (or Spearman, if more appropriate) will be assessed to determine the strength of the agreement. Agreement of the tumor classifications (response versus no response) will be summarized as the raw agreement and with a Kappa Statistic. The association of the change in tumor volume with survival will be evaluated in two ways. The first will be to use the change in tumor volume as a time dependent variable in a Cox model. The second will be a landmark analysis (done at either the first radiographic assessment or at the second radiographic assessment) to compare the survival of patients classified as a responder (based on tumor volume) to those who have not responded by the selected landmark time. Patients who died prior to the landmark time point will be omitted from analysis. |
| Other | Number of TAZ-CAMTA1 Gene Fusion | Up to 6 months | Will be evaluated by fluorescence in situ hybridization. |
| Other | Percent of TAZ-CAMTA1 Gene Fusion | Up to 6 months | Will be evaluated by fluorescence in situ hybridization. |
| Other | MAP Kinase Activation | Up to 6 months | Will be analyzed by immunohistochemistry. Descriptive statistics will be generated, and estimates for the proportion of samples with demonstrated inhibition of MAPK signaling post-treatment compared to pre-treatment will be generated along with 95% confidence intervals. Likewise, the proportion of patients with demonstrated MAPK signaling inhibition at time of disease progression will be determined with the corresponding 95% confidence interval. |
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.
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