ClinicalTrials.gg
CompletedNCT03331250Updated Aug 28, 2026Results posted

Eribulin in Angiosarcoma and Epithelioid Hemangioendothelioma (EHE)

A Phase 2 interventional study of Eribulin in Angiosarcoma and Epithelioid Hemangioendothelioma, sponsored by Massachusetts General Hospital. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-28.

Sponsored by Massachusetts General Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
13
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This research study is studying a drug as a possible treatment for Angiosarcoma or Epithelioid hemangioendothelioma (EHE).

-The drug involved in this study is Eribulin

Read the detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.

The FDA (the U.S. Food and Drug Administration) has not approved Eribulin for your specific disease but it has been approved for other uses.

In this research study, the investigators are studying how safe and effective eribulin is in participants with Angiosarcoma or EHE.

Eribulin was created to mimic the structure of a chemical that is released from a sea sponge. The investigators believe that this drug has anti-cancer effects on tumors by blocking proteins called microtubules, among other functions. It may work by preventing the cancer cells from dividing and eventually cause the tumor cells to die similar to other drugs that target microtubules

02

Conditions studied

  • Angiosarcoma
  • Epithelioid Hemangioendothelioma

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Keywords

  • Epithelioid hemangioendothelioma (EHE)
  • Angiosarcoma
03

In context

Hemangiosarcoma

99 studies on the registry are indexed under Hemangiosarcoma; 16 are open to participants now.

This study's enrollment of 13 is below the median of 64 across 83 interventional studies indexed under Hemangiosarcoma.

Browse Hemangiosarcoma studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.

Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • or locally advanced angiosarcoma, treated with at least one prior systemic therapy where no standard of care curable therapy is available OR metastatic or locally advanced malignant and progressive epithelioid hemangioendothelioma (EHE).
  • A maximum of 5 EHE patients will be accrued on this study
  • confirming the diagnosis must be reviewed by BWH/DFCI/MGH pathology.
  • Progression on at least one prior systemic therapy or progression during an observation phase of no anti-cancer therapy within the prior 3 months; prior taxanes are allowed
  • Participants must have by 1.1, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam.
  • Age > 18 years.
  • performance status ≤2
  • of greater than 3 months
  • Participants must have normal organ and marrow function as defined below:

    • leukocytes ≥3,000/mcL
    • ≥1,000/mcL
    • ≥100,000/mcL
    • total within normal institutional limits
    • (SGOT)/ALT(SGPT) ≤2.5 × institutional
    • ≥50 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.
  • Baseline \< grade 2
  • The effects of Eribulin on the developing human fetus are unknown. For this reason and because of the risk of teratogenicity, women of must agree to use adequate prior to study entry and for the duration of study participation, and 4 months after completion of Eribulin administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of Eribulin administration.
  • Willingness to undergo serial tumor biopsies before and on treatment.
  • Ability to understand and the willingness to sign a written document.

Exclusion criteria

Exclusion Criteria:

  • Participants who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C), immunotherapy within 3 weeks, targeted therapies (e.g. small molecule inhibitors such as pazopanib) within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. Not or clinically stable adverse events from prior therapy (e.g. immunotherapy related hypothyroidism or insulin-dependent diabetes stable on medication or TKI-related hypertension or rash etc.) is allowed.
  • Participants who are receiving any other agents.
  • Participants with known and/or should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to eribulin.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure ( Class II), unstable angina pectoris or myocardial infarction within 6 months of enrolment, serious or life-threatening cardiac arrhythmia, subjects with a high probability of Long syndrome or QTcF prolongation of > 501 mcsec (grade 2) on at least two separate following correction of any electrolyte imbalance or psychiatric illness/social situations that would limit compliance with study requirements.
  • Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [ß-hCG] (or human chorionic gonadotropin [hCG]) test with a minimum sensitivity of 25 IU/L or equivalent units of ß-hCG [or hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
  • -positive participants on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with Eribulin. In addition, these participants are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated
Terms in these criteria, in plain language(23)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    Eribulin

    * Eribulin administered twice per cycle intravenously * Each cycle contains 21 days * Dosing is per the FDA label for other cancers

    Drug: Eribulin

Interventions

  • It may work by preventing the cancer cells from dividing and eventually cause the tumor cells to die

    Also known as: Halaven

06

What researchers measure

Primary outcomes

  1. Objective Response Rate (ORR)

    The ORR is defined as the percentage of patients who achieved a partial response or complete response by RECIST 1.1. Tumor imaging studies were completed using either CT (Computed Tomography) or MRI (Magnetic resonance imaging). The modality chosen for any individual patient was the same from baseline until the end of their time on study. Per RECIST v 1.1, complete response (CR) is defined as the disappearance of all target lesions and the reduction in any pathological lymph nodes in short axis to less than 10 mm. Partial response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions compared with baseline. Progressive disease (PD) is defined as a 20% increase (5+ mm absolute increase) compared with the smallest sum on study. Stable disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor PD.

    Time frame: 2 years

Secondary outcomes

  1. Progression Free Survival

    Progression-free survival, will be defined as the duration of time from start of treatment to time of progression or death, whichever occurs first and will be estimated using the Kaplan-Meier method.

    Time frame: All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.

  2. Disease Control Rate

    Objective Response plus Stable Disease Rate at 24 weeks

    Time frame: 24 weeks

  3. Treatment Related Adverse Events

    Summary of the treatment related adverse events experienced by study participants as assessed by Common Terminology Criteria for Adverse Events (CTCAE v4). Grade 3+ only.

    Time frame: All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks).

07

Results

Posted Nov 8, 2024

Participant flow

13 participants were enrolled on this study.

Participant flow — Overall Study
MilestoneEribulin
Started13
Completed13
Not completed0

Outcome measures

PrimaryObjective Response Rate (ORR)

The ORR is defined as the percentage of patients who achieved a partial response or complete response by RECIST 1.1. Tumor imaging studies were completed using either CT (Computed Tomography) or MRI (Magnetic resonance imaging). The modality chosen for any individual patient was the same from baseline until the end of their time on study. Per RECIST v 1.1, complete response (CR) is defined as the disappearance of all target lesions and the reduction in any pathological lymph nodes in short axis to less than 10 mm. Partial response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions compared with baseline. Progressive disease (PD) is defined as a 20% increase (5+ mm absolute increase) compared with the smallest sum on study. Stable disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor PD.

Time frame:
2 years
Reported as:
Count of participants · Participants
Objective Response Rate (ORR)
ParticipantsAngiosarcomaEpithelioid Hemangioendothelioma (EHE)Overall
Objective Response Rate (ORR)224
SecondaryProgression Free Survival

Progression-free survival, will be defined as the duration of time from start of treatment to time of progression or death, whichever occurs first and will be estimated using the Kaplan-Meier method.

Time frame:
All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
Reported as:
Median · months
Progression Free Survival
monthsOverall
Progression Free Survival1.6 (1.4 to NA)
SecondaryDisease Control Rate

Objective Response plus Stable Disease Rate at 24 weeks

Time frame:
24 weeks
Reported as:
Count of participants · Participants
Disease Control Rate
ParticipantsOverall Cohort
Disease Control Rate6 (16 to 51)
SecondaryTreatment Related Adverse Events

Summary of the treatment related adverse events experienced by study participants as assessed by Common Terminology Criteria for Adverse Events (CTCAE v4). Grade 3+ only.

Time frame:
All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks).
Reported as:
Count of participants · Participants
Treatment Related Adverse Events
ParticipantsAll Participants
Grades 1-211
Grade 32
Grade 40
Grade 50

Adverse events

Collected over All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Eribulin11/13 (84.6%)3/13 (23.1%)13/13 (100%)
Most frequent serious events
Most frequent serious events
EventEribulin
AnemiaBlood and lymphatic system disorders1/13
DyspneaRespiratory, thoracic and mediastinal disorders1/13
Periorbital infectionInfections and infestations1/13
Pleural effusionRespiratory, thoracic and mediastinal disorders1/13
TyphlitisGastrointestinal disorders1/13
Most frequent other events
Showing 10 of 30
Most frequent other events
EventEribulin
Peripheral sensory neuropathyNervous system disorders6/13
AnemiaBlood and lymphatic system disorders4/13
FatigueGeneral disorders4/13
Neutrophil count decreasedInvestigations3/13
White blood cell decreasedInvestigations3/13
Alanine aminotransferase increasedInvestigations2/13
AlopeciaSkin and subcutaneous tissue disorders2/13
AnorexiaMetabolism and nutrition disorders2/13
Aspartate aminotransferase increasedInvestigations2/13
ConstipationGastrointestinal disorders2/13

Baseline characteristics

Age, Continuous
Age, Continuous(years)Eribulin
Mean61.7 (42.2 to 76.8)
Sex: Female, Male
Sex: Female, Male(Participants)Eribulin
Female5
Male8
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Eribulin
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White13
More than one race0
Unknown or Not Reported0
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Eribulin
Hispanic or Latino0
Not Hispanic or Latino12
Unknown or Not Reported1
ECOG Performance Status
ECOG Performance Status(Participants)Eribulin
06
16
21
Disease
Disease(Participants)Eribulin
Angiosarcoma10
Epithelioid Hemangioendothelioma (EHE)3
08

Study locations

2 sites
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Dana Farber Cancer Institute
    Boston, Massachusetts 02115, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03331250
Collaborators
Eisai Inc.
Responsible party
Gregory Cote (Principal Investigator, Massachusetts General Hospital) — Principal investigator
First posted
Nov 6, 2017
Start date
Jan 18, 2018
Primary completion
Mar 31, 2022
Completion
May 23, 2023
Results posted
Nov 8, 2024
Last update
Aug 28, 2026

Study contacts

Gregory Cote, MD, PhD
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Eribulin

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