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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Response Rate

Secondary outcome measures

Disease Control Rate

Progression Free Survival

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

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

~2700

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,932 Previous Clinical Trials

13,198,482 Total Patients Enrolled

Eisai Inc.Industry Sponsor

515 Previous Clinical Trials

153,958 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.

Media Library

Eribulin (Microtubule Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03331250 — Phase 2

Hemangiosarcoma Research Study Groups: Eribulin

Hemangiosarcoma Clinical Trial 2023: Eribulin Highlights & Side Effects. Trial Name: NCT03331250 — Phase 2

Eribulin (Microtubule Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03331250 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent can Eribulin be detrimental to human health?

"In terms of safety, eribulin was assessed a score of 2 as it is in its second clinical trial and the efficacy has yet to be objectively determined."

Answered by AI

Is there currently a vacancy for participants in this research endeavor?

"That is correct. According to the clinicaltrials.gov website, recruitment for this trial commenced on January 18th 2018 and has continued since its last edit in February 14th 2022. This research aims to enroll a total of 16 patients from one site."

Answered by AI

Are there any other experiments that have been conducted with Eribulin?

"Presently, 37 research projects are actively studying Eribulin with 10 of the studies in Phase 3. While primarily occurring in Seoul and Florida, these clinical trials span 1225 locations worldwide."

Answered by AI

How much interest has this trial attracted in terms of participants?

"Affirmative. According to information hosted on clinicaltrials.gov, recruitment for this medical study has been ongoing since it was initially posted on January 18th 2018 and recently updated on February 14th 2022. Patients are being sought out from 1 site with a total target of 16 participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Eribulin in Angiosarcoma and Epithelioid Hemangioendothelioma (EHE)

Gregory Cote 2018. "Eribulin in Angiosarcoma and Epithelioid Hemangioendothelioma (EHE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03331250.

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