AngiosarcomaPhase 2NCT03331250
Eribulin in Angiosarcoma and Epithelioid Hemangioendothelioma (EHE)
A Phase 2 study testing Eribulin in people with Angiosarcoma and Epithelioid Hemangioendothelioma, run by Massachusetts General Hospital at 2 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angiosarcoma, Epithelioid Hemangioendothelioma
- What is being tested?
- Eribulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Jan 2018to 23 May 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Metastatic 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
- Archival tissue 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 measurable disease by RECIST 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.
Show all 19Show fewer
- ECOG performance status ≤2
- Life expectancy of greater than 3 months
- Participants must have normal organ and marrow function as defined below:
- leukocytes ≥3,000/mcL
- absolute neutrophil count ≥1,000/mcL
- platelets ≥100,000/mcL
- total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
- creatinine clearance ≥50 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.
- Baseline QTcF < 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 child-bearing potential must agree to use adequate contraception 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 informed consent document.
Who cannot join
- 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 clinically significant 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 investigational agents.
- Participants with known brain metastases and/or leptomeningeal disease 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 (NYHA 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 QT syndrome or QTcF prolongation of > 501 mcsec (grade 2) on at least two separate ECG 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.
- HIV-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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Pilot Phase 2 Study of Eribulin in Angiosarcoma and Epithelioid Hemangioendothelioma (EHE)
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
- Conditions
- Angiosarcoma, Epithelioid Hemangioendothelioma
- Being tested
- Eribulin
- Keywords
- Epithelioid hemangioendothelioma (EHE), Angiosarcoma
- Medical subject headings
- Hemangiosarcoma, Hemangioendothelioma, Epithelioid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EribulinDrug
Also called Halaven
It may work by preventing the cancer cells from dividing and eventually cause the tumor cells to die
| Study group | Role | What they receive |
|---|---|---|
| Eribulin | Experimental | * Eribulin administered twice per cycle intravenously
* Each cycle contains 21 days
* Dosing is per the FDA label for other cancers Receives: Drug: Eribulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (3)
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.
Measured: 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.
Disease Control Rate
Objective Response plus Stable Disease Rate at 24 weeks
Measured: 24 weeks
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.
Measured: All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start18 Jan 2018
- Primary completion31 Mar 2022
- Study completion23 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AngiosarcomaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eisai Inc.
- Responsible party
- Principal investigator, Gregory Cote, Massachusetts General Hospital
- Investigators
- Gregory Cote, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03331250
- Sponsor's protocol ID
- 17-355
- Status last verified
- Aug 2026
- First submitted
- 26 Oct 2017
- Last updated
- 28 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Phase 2 Study of Eribulin in Angiosarcoma and Epithelioid Hemangioendothelioma (EHE)
- ClinicalTrials.gov ID
- NCT03331250
- Acronym / sponsor ID
- 17-355
- Conditions
- Angiosarcoma, Epithelioid Hemangioendothelioma
- Keywords
- Epithelioid hemangioendothelioma (EHE), Angiosarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Eisai Inc.
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 23 May 2023 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Posted 8 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eribulin | Experimental | Drug: Eribulin* Eribulin administered twice per cycle intravenously * Each cycle contains 21 days * Dosing is per the FDA label for other cancers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Metastatic 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
- Archival tissue 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 measurable disease by RECIST 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.
Key exclusion criteria (7 listed)
- 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 clinically significant 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 investigational agents.
- Participants with known brain metastases and/or leptomeningeal disease 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 (NYHA 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 QT syndrome or QTcF prolongation of > 501 mcsec (grade 2) on at least two separate ECG following correction of any electrolyte imbalance or psychiatric illness/social situations that would limit compliance with study requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EribulinAlso: HalavenIt may work by preventing the cancer cells from dividing and eventually cause the tumor cells to die | Drug | Eribulin |
Primary outcome
Objective Response Rate (ORR)
Time frame: 2 years
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.
3 secondary outcomes
Progression Free Survival
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.
Disease Control Rate
Time frame: 24 weeks
Treatment Related Adverse Events
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Cote, MD, PhD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Eribulin in people with Angiosarcoma and Epithelioid Hemangioendothelioma, run by Massachusetts General Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.