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Microtubule Inhibitor

Eribulin for Hemangiosarcoma and Epithelioid Hemangioendothelioma

Phase 2

Waitlist Available

Led By Gregory Cote, MD, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age > 18 years

ECOG performance status ≤2

Must not have

Females who are breastfeeding or pregnant at Screening or Baseline

Participants with known brain metastases and/or leptomeningeal disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a drug called Eribulin as a possible treatment for two types of cancer: Angiosarcoma and Epithelioid Hemangioendothelioma (EHE).

Who is the study for?

This trial is for adults over 18 with advanced angiosarcoma or epithelioid hemangioendothelioma (EHE) who've had at least one prior treatment. They must have measurable disease, a life expectancy over three months, and normal organ/marrow function. Women of childbearing age and men must use contraception. Those with brain metastases, certain heart conditions, or uncontrolled illnesses can't join.

What is being tested?

The study tests Eribulin as a potential treatment for Angiosarcoma or Epithelioid Hemangioendothelioma (EHE). Participants will receive Eribulin after having progressed on previous therapies. The trial includes tumor biopsies before and during treatment to assess the drug's effect.

What are the potential side effects?

While not specified in the provided information, common side effects of Eribulin may include fatigue, low white blood cell count (which can increase infection risk), hair loss, nausea, constipation or diarrhea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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I can take care of myself but might not be able to do heavy physical work.

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My diagnosis was confirmed by a specific hospital's pathology department.

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My blood tests show normal organ function and I don't have severe heart rhythm issues.

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I have a tumor that can be measured with scans or clinical exam.

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I have advanced angiosarcoma or EHE and have tried at least one treatment.

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I am willing to have multiple tumor biopsies.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding.

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I have brain metastases or leptomeningeal disease.

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I do not have any serious ongoing illnesses that would affect my participation.

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I am HIV-positive and on combination antiretroviral therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR)

Secondary study objectives

Disease Control Rate

Treatment Related Adverse Events

Side effects data

From 2016 Phase 3 trial • 540 Patients • NCT01454934

36%

Decreased appetite

34%

Neutropenia

30%

Alopecia

27%

Nausea

25%

Fatigue

23%

Constipation

22%

Neutrophil count decreased

22%

Anaemia

22%

Asthenia

21%

Dyspnoea

20%

White blood cell count decreased

17%

Pyrexia

16%

Stomatitis

16%

Cough

16%

Peripheral sensory neuropathy

15%

Oedema peripheral

14%

Diarrhoea

13%

Headache

11%

Vomiting

10%

Leukopenia

10%

Myalgia

Back pain

Dysgeusia

Musculoskeletal pain

Paraesthesia

Malaise

Alanine aminotransferase increased

Weight decreased

Musculoskeletal chest pain

Haemoptysis

Arthralgia

Aspartate aminotransferase increased

Insomnia

Productive cough

Abdominal Pain Upper

Rash

General physical health deterioration

Upper respiratory tract infection

Abdominal Pain

Pain in extremity

Muscle Spasms

Muscular Weakness

Dizziness

Pneumonia

Lung infection

Neutropenic sepsis

Hypercalcaemia

Confusional state

Non-cardiac chest pain

Febrile neutropenia

Myocardial ischaemia

Respiratory tract infection

Metastases to central nervous system

Metastatic pain

Chronic obstructive pulmonary disease

Pleural effusion

Pulmonary embolism

100%

80%

60%

40%

20%

Study treatment Arm

Arm A: Eribulin Mesylate

Arm B: Vinorelbine, Gemcitabine, Docetaxel, or Pemetrexed

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: EribulinExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Eribulin

2012

Completed Phase 3

~2740

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

3,014 Previous Clinical Trials

13,309,418 Total Patients Enrolled

Eisai Inc.Industry Sponsor

521 Previous Clinical Trials

159,835 Total Patients Enrolled

Gregory Cote, MD, PhD3.04 ReviewsPrincipal Investigator - Massachusetts General Hospital

Massachusetts General Hospital

1Patient Review

I was once a satisfied customer, but after being put on a clinical trial and then removed after less-than-favourable results, I found it difficult to get this physician to return my calls or emails. He seemed to want nothing to do with me, and during the six months he ignored me, six tumors grew. I would not recommend him to anyone I cared about.