Clinical Trials /

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

Related Conditions:
  • Angiosarcoma
  • Epithelioid Hemangioendothelioma
Recruiting Status:



Phase 2

Trial Eligibility



  • Brief Title: Eribulin in Angiosarcoma and Epithelioid Hemangioendothelioma (EHE)
  • Official Title: A Pilot Phase 2 Study of Eribulin in Angiosarcoma and Epithelioid Hemangioendothelioma (EHE)

Clinical Trial IDs

  • ORG STUDY ID: 17-355
  • NCT ID: NCT03331250


  • Angiosarcoma
  • Epithelioid Hemangioendothelioma




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

Trial Arms

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

Eligibility Criteria

        Inclusion Criteria:

          -  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

          -  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.

          -  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.

        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 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
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective Response Rate
Time Frame:2 years
Safety Issue:
Description:Partial response rate plus complete response rate by RECIST 1.1

Secondary Outcome Measures

Measure:Progression Free Survival
Time Frame:4 years
Safety Issue:
Measure:Disease Control Rate
Time Frame:24 weeks
Safety Issue:
Description:Objective Response plus Stable Disease Rate at 24 weeks
Measure:Treatment Related Adverse Events
Time Frame:4 years
Safety Issue:
Description:Summary of the treatment related adverse events experienced by study participants as assessed by Common Terminology Criteria for Adverse Events (CTCAE v4)


Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Massachusetts General Hospital

Trial Keywords

  • Epithelioid hemangioendothelioma (EHE)
  • Angiosarcoma

Last Updated

February 3, 2021