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Eribulin Mesylate

Eribulin Mesylate, also known as E7389 or Halaven, is a synthetic analogue of a compound derived from marine sponges. It is being studied in various clinical trials for its potential in treating different types of cancer, including breast cancer, prostate cancer, and non-small cell lung cancer. These trials aim to evaluate the drug’s safety, efficacy, and optimal dosing strategies in different patient populations and treatment combinations.

Table of Contents

What is Eribulin Mesylate?

Eribulin Mesylate, also known by its brand name Halaven, is a chemotherapy drug used to treat certain types of cancer[1]. It is a synthetic version of a substance originally found in a sea sponge called Halichondria okadai[2]. Eribulin Mesylate is part of a class of drugs known as microtubule dynamics inhibitors, which means it works by interfering with the way cancer cells divide and grow[2].

How Does Eribulin Mesylate Work?

Eribulin Mesylate works by inhibiting the growth of microtubules, which are essential structures in cells that play a crucial role in cell division[2]. By disrupting this process, Eribulin Mesylate can stop cancer cells from dividing and spreading. This mechanism of action is different from some other chemotherapy drugs, which may make it effective in cases where other treatments have failed[1].

What Conditions Does Eribulin Mesylate Treat?

Eribulin Mesylate is primarily used to treat:

  • Metastatic Breast Cancer: This is breast cancer that has spread to other parts of the body. Eribulin is often used in patients who have already tried at least two other chemotherapy regimens for advanced disease, including an anthracycline and a taxane[1].
  • Locally Advanced Breast Cancer: This refers to breast cancer that has spread from where it started in the breast to nearby tissue or lymph nodes[3].
  • Triple Negative Breast Cancer (TNBC): This is an aggressive type of breast cancer that lacks certain receptors, making it harder to treat. Some studies are exploring the use of Eribulin as a maintenance treatment after standard chemotherapy for TNBC[4].
  • Advanced Solid Tumors: Some studies have investigated the use of Eribulin in various types of advanced solid tumors[5].

How is Eribulin Mesylate Administered?

Eribulin Mesylate is typically administered as an intravenous (IV) injection. The usual dosing schedule is:

  • 1.4 mg/m² (or 1.23 mg/m² in some cases) given over 2 to 5 minutes on days 1 and 8 of a 21-day cycle[3][2].
  • Treatment continues until the disease progresses or unacceptable side effects occur[1].

The exact dosage and schedule may vary depending on individual patient factors and the specific condition being treated.

Efficacy of Eribulin Mesylate

Several studies have shown Eribulin Mesylate to be effective in treating advanced breast cancer:

  • In patients with metastatic breast cancer who had previously received at least two chemotherapy regimens, Eribulin has shown to improve overall survival[1].
  • Some studies have reported objective response rates (a measure of tumor shrinkage) of around 29% in first-line treatment of metastatic breast cancer[2].
  • Research is ongoing to determine its effectiveness as a maintenance treatment in triple negative breast cancer[4].

Side Effects and Safety

Like all chemotherapy drugs, Eribulin Mesylate can cause side effects. Common side effects include:

  • Fatigue/Asthenia: Feeling very tired or weak[1]
  • Neutropenia: A decrease in white blood cells, which can increase the risk of infections[1]
  • Peripheral Neuropathy: Numbness, tingling, or pain in the hands and feet[1]
  • Alopecia: Hair loss[1]
  • Nausea and Constipation[1]

Doctors closely monitor patients for these side effects and may adjust the dose or provide supportive treatments as needed[3].

Use in Special Populations

Research has been conducted to understand how Eribulin Mesylate can be used in specific patient groups:

  • Elderly Patients: Studies have explored the use of Eribulin in patients aged 70 and older, often starting with a reduced dose to minimize side effects[2].
  • Patients with Liver Problems: The dosage of Eribulin may need to be adjusted for patients with mild to moderate liver impairment[5].

Ongoing Research

Researchers continue to study Eribulin Mesylate to understand its full potential:

  • Its use in combination with other cancer drugs, such as bevacizumab, is being explored[6].
  • Studies are investigating its effectiveness as a first-line treatment for metastatic breast cancer[6].
  • Research is ongoing to identify genetic markers that might predict which patients will respond best to Eribulin or experience fewer side effects[1].

As with all cancer treatments, the decision to use Eribulin Mesylate should be made in consultation with your oncologist, taking into account your specific medical history and condition.

Aspect Details
Drug Name Eribulin Mesylate (E7389, Halaven)
Mechanism of Action Inhibits microtubule dynamics, affecting cancer cell growth and division
Administration Intravenous injection, typically over 2-5 minutes
Cancer Types Studied Advanced breast cancer, prostate cancer, non-small cell lung cancer
Key Trial Objectives Safety, efficacy, optimal dosing, pharmacokinetics
Outcome Measures Tumor response, progression-free survival, overall survival
Safety Monitoring Adverse events, laboratory tests, vital signs, physical examinations
Special Populations Elderly patients, patients with hepatic impairment
Combination Therapies Studied with drugs like pemetrexed and rifampicin

FAQ

  • What is Eribulin Mesylate? Eribulin Mesylate is a synthetic drug derived from a compound found in marine sponges. It works by inhibiting microtubule dynamics, which affects cancer cell growth and division.
  • What types of cancer is Eribulin Mesylate being studied for? Clinical trials are exploring Eribulin Mesylate's potential in treating various cancers, including advanced breast cancer, prostate cancer, and non-small cell lung cancer.
  • How is Eribulin Mesylate administered? Eribulin Mesylate is typically given as an intravenous (IV) injection, usually over 2 to 5 minutes. The dosing schedule can vary depending on the specific trial and treatment plan.
  • What are some common side effects of Eribulin Mesylate? While side effects can vary, some commonly reported ones include fatigue, nausea, hair loss, and changes in blood cell counts. The trials are closely monitoring all adverse events to ensure patient safety.
  • How do clinical trials determine if Eribulin Mesylate is effective? Trials use various measures to assess effectiveness, including tumor response rates, progression-free survival, and overall survival. They also evaluate how well patients tolerate the treatment and its impact on quality of life.

Ongoing Clinical Trials on Eribulin Mesylate

  • Study of BNT327 and a drug combination for patients with untreated metastatic or locally recurrent triple-negative breast cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Czechia France Germany Italy The Netherlands +2

  • Study on zAvatar Test for Treatment Decisions in Relapsed Ovarian Cancer and Metastatic Breast Cancer Using Palbociclib and Drug Combination for Eligible Patients

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Portugal

  • Study on Zanidatamab and Chemotherapy for Patients with Metastatic HER2-Positive Breast Cancer After Trastuzumab Deruxtecan Treatment

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium France Germany Greece Italy +2

  • Zanidatamab, tucatinib, capecitabine or eribulin mesylate in HER2-positive advanced breast cancer in adults

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on the Effectiveness and Safety of Datopotamab Deruxtecan Compared to Chemotherapy in Adults with Advanced Triple-negative Breast Cancer

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Hungary Italy Poland +1

  • Study Comparing Datopotamab Deruxtecan to Chemotherapy in Patients with Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Belgium France Germany Hungary Italy Poland +1

Glossary

  • Pharmacokinetics: The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Metastatic: Cancer that has spread from its original site to other parts of the body.
  • Progression-free Survival: The length of time during and after treatment that a patient lives without the cancer getting worse.
  • Dose-Limiting Toxicity: Side effects of a drug that are severe enough to prevent an increase in dosage or require a decrease in dosage.
  • RECIST: Response Evaluation Criteria in Solid Tumors, a set of rules used to measure how well a cancer patient responds to treatment.
  • Child-Pugh System: A scoring system used to assess the severity of chronic liver disease and predict the likelihood of major complications.
  • Triple Negative Breast Cancer: A type of breast cancer that lacks receptors for estrogen, progesterone, and HER2, making it more difficult to treat with hormone therapies.
  • Adjuvant Chemotherapy: Additional cancer treatment given after the primary treatment to lower the risk that the cancer will come back.
  • Cytochrome P450 3A4 enzyme (CYP3A4): An important enzyme in the body involved in the metabolism of many drugs.

References

  1. https://clinicaltrials.gov/study/NCT02864030
  2. https://clinicaltrials.gov/study/NCT02404506
  3. https://clinicaltrials.gov/study/NCT03583944
  4. https://clinicaltrials.gov/study/NCT04502680
  5. https://clinicaltrials.gov/study/NCT00706095
  6. https://clinicaltrials.gov/study/NCT01941407