Eribulin in Angiosarcoma and Epithelioid Hemangioendothelioma (EHE)

NCT03331250 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 1 other identifier: 17-355
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Angiosarcoma; Epithelioid Hemangioendothelioma

Keywords

Epithelioid hemangioendothelioma (EHE); Angiosarcoma

Outcome Measures

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.

  2 years

Secondary Outcomes (3)

• Progression Free Survival

  4 years

• Disease Control Rate

  24 weeks

• Treatment Related Adverse Events

  4 years

Study Arms (1)

Eribulin

EXPERIMENTAL

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

Drug: Eribulin

Interventions

Eribulin DRUG

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

Also known as: Halaven

Eribulin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Eisai Inc.: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Hemangiosarcoma; Hemangioendothelioma, Epithelioid

Interventions

eribulin

Condition Hierarchy (Ancestors)

Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Hemangioendothelioma; Hemangioma

Results Point of Contact

• Title: Gregory Cote, MD, PhD
• Organization: Massachusetts General Hospital

GCOTE@mgh.harvard.edu

617-726-8748

Study Officials

• Gregory Cote, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 26, 2017
• First Posted: November 6, 2017
• Study Start: January 18, 2018
• Primary Completion: July 21, 2023
• Study Completion: February 1, 2026
• Last Updated: December 23, 2025
• Results First Posted: November 8, 2024

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)