Trial · NCT03148275

Trametinib in Treating Patients With Epithelioid Hemangioendothelioma That is Metastatic, Locally Advanced, or Cannot Be Removed by Surgery

NCT03148275, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2024-11-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Trametinib in Treating Patients With Epithelioid Hemangioendothelioma That is Metastatic, Locally Advanced, or Cannot Be Removed by Surgery. Trials, record NCT03148275. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03148275

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Trametinib in Treating Patients With Epithelioid Hemangioendothelioma That is Metastatic, Locally Advanced, or Cannot Be Removed by Surgery
NCT number: NCT03148275
Status: Completed
Phases: Phase 2
Enrollment: 44 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Locally Advanced Epithelioid Hemangioendothelioma, Metastatic Epithelioid Hemangioendothelioma, Unresectable Epithelioid Hemangioendothelioma
Interventions: Questionnaire Administration, Trametinib
First posted: 2017-05-10
Last updated: 2024-11-26
Results first posted: 2024-11-26

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

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.

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Objective Response Rate	6 months		Percentage	NUMBER
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		percentage of participants	NUMBER
SECONDARY	Overall Survival	From the time of first dose of study drug to occurrence of death from any cause, assessed at 2 years		Percentage	NUMBER
SECONDARY	Incidence of Adverse Events	at 6 months		participants who experienced the event	NUMBER
SECONDARY	Change in Patient Reported Symptoms	Baseline and at 6 months	as participants were removed from trial, the number of completed PROMIS forms decreased	T Score	MEAN
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		months	MEDIAN
OTHER_PRE_SPECIFIED	Change in Epithelioid Hemangioendothelioma Growth Rate	Baseline up to 6 months
OTHER_PRE_SPECIFIED	Change in CRP Level	Baseline up to 6 months
OTHER_PRE_SPECIFIED	Change in ESR Level	Baseline up to 6 months
OTHER_PRE_SPECIFIED	Change in Plasma CTGF Level	Baseline up to 6 months

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group156

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Objective Response Rate	Treatment (Trametinib)		9.5	95% Confidence Interval 3.1 to 23.5	Percentage
6 Month Progression-free Survival	Treatment (Trametinib)		66.5	95% Confidence Interval 53.6 to 82.5	percentage of participants
Overall Survival	Treatment (Trametinib)		41.1	95% Confidence Interval 28.1 to 60.1	Percentage
Incidence of Adverse Events	Treatment (Trametinib)	Abdominal Pain	3		participants who experienced the event
Incidence of Adverse Events	Treatment (Trametinib)	Alanine Aminotransferase Increased	8		participants who experienced the event
Incidence of Adverse Events	Treatment (Trametinib)	Alkaline Phosphatase Increased	8		participants who experienced the event
Incidence of Adverse Events	Treatment (Trametinib)	Alopecia	13		participants who experienced the event
Incidence of Adverse Events	Treatment (Trametinib)	Anemia	21		participants who experienced the event
Incidence of Adverse Events	Treatment (Trametinib)	Anorexia	11		participants who experienced the event
Incidence of Adverse Events	Treatment (Trametinib)	Anxiety	6		participants who experienced the event

1 to 10 of 156Source ClinicalTrials.gov

See all 156 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Treatment (Trametinib)	44
Overall Study	COMPLETED	Treatment (Trametinib)	25
Overall Study	NOT COMPLETED	Treatment (Trametinib)	19

Source ClinicalTrials.gov

Adverse events112

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	Treatment (Trametinib)	3	42	10
other	Alanine aminotransferase increased	Investigations	Treatment (Trametinib)	8	42	15
other	Alkaline phosphatase increased	Investigations	Treatment (Trametinib)	8	42	28
other	Alopecia	Skin and subcutaneous tissue disorders	Treatment (Trametinib)	13	42	13
other	Anemia	Investigations	Treatment (Trametinib)	21	42	62
other	Anorexia	Metabolism and nutrition disorders	Treatment (Trametinib)	11	42	15
other	Anxiety	Psychiatric disorders	Treatment (Trametinib)	6	42	7
other	Aspartate aminotransferase increased	Investigations	Treatment (Trametinib)	13	42	35
other	Blurred vision	Eye disorders	Treatment (Trametinib)	6	42	9
other	Bruising	General disorders	Treatment (Trametinib)	3	42	3

1 to 10 of 112Source ClinicalTrials.gov

See all 112 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Treatment (Trametinib)	27	42
Total, other adverse events	Treatment (Trametinib)	42	42
Total, serious adverse events	Treatment (Trametinib)	25	42

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35443056	DERIVED

Source PubMed

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
P30CA046592	University of Michigan Rogel Cancer Center Support Grant 2023-2028	FEARON, ERIC R.	UNIVERSITY OF MICHIGAN AT ANN ARBOR	NATIONAL CANCER INSTITUTE	1988 to 2025

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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