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Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR HALAVEN


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All Clinical Trials for Halaven

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00365157 ↗ Eribulin Mesylate in Treating Patients With Locally Advanced or Metastatic Cancer of the Urothelium and Kidney Dysfunction Active, not recruiting National Cancer Institute (NCI) Phase 1/Phase 2 2006-10-23 This phase I/II trial studies the effect of eribulin mesylate and to see how well it works in treating patients with cancer of the urothelium that has spread to nearby tissue (locally advanced) or to other places in the body (metastatic)and kidney dysfunction. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Chemotherapy drugs may have different effects in patients who have changes in their kidney function.
NCT00410553 ↗ Eribulin Mesylate and Gemcitabine Hydrochloride in Treating Patients With Metastatic Solid Tumors or Solid Tumors That Cannot be Removed by Surgery Completed National Cancer Institute (NCI) Phase 1 2006-11-14 This phase I trial is studying the side effects and best dose of eribulin mesylate and gemcitabine hydrochloride in treating patients with metastatic or unresectable solid tumors. Drugs used in chemotherapy, such as eribulin mesylate and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
NCT01372579 ↗ Carboplatin and Eribulin Mesylate in Triple Negative Breast Cancer Patients Unknown status Eisai Inc. Phase 2 2011-08-01 This phase II trial studies how well giving eribulin mesylate and carboplatin together before surgery works in treating patients with stage I-III triple-negative breast cancer. Drugs used in chemotherapy, such as eribulin mesylate and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
NCT01372579 ↗ Carboplatin and Eribulin Mesylate in Triple Negative Breast Cancer Patients Unknown status Northwestern University Phase 2 2011-08-01 This phase II trial studies how well giving eribulin mesylate and carboplatin together before surgery works in treating patients with stage I-III triple-negative breast cancer. Drugs used in chemotherapy, such as eribulin mesylate and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Halaven

Condition Name

Condition Name for Halaven
Intervention Trials
Breast Cancer 16
Metastatic Breast Cancer 12
Stage III Bladder Urothelial Carcinoma AJCC v6 and v7 3
Liposarcoma 3
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Condition MeSH

Condition MeSH for Halaven
Intervention Trials
Breast Neoplasms 45
Carcinoma 8
Triple Negative Breast Neoplasms 8
Carcinoma, Transitional Cell 5
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Clinical Trial Locations for Halaven

Trials by Country

Trials by Country for Halaven
Location Trials
United States 250
Spain 13
Canada 11
India 10
France 5
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Trials by US State

Trials by US State for Halaven
Location Trials
Florida 14
Texas 13
Missouri 11
California 10
New York 10
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Clinical Trial Progress for Halaven

Clinical Trial Phase

Clinical Trial Phase for Halaven
Clinical Trial Phase Trials
Phase 4 2
Phase 3 7
Phase 2 36
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Clinical Trial Status

Clinical Trial Status for Halaven
Clinical Trial Phase Trials
Completed 19
Recruiting 15
Active, not recruiting 10
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Clinical Trial Sponsors for Halaven

Sponsor Name

Sponsor Name for Halaven
Sponsor Trials
Eisai Inc. 18
National Cancer Institute (NCI) 11
Dana-Farber Cancer Institute 6
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Sponsor Type

Sponsor Type for Halaven
Sponsor Trials
Other 61
Industry 41
NIH 11
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HALAVEN (Eribulin Mesylate): Clinical Trials, Market Analysis, and Projections

Introduction

HALAVEN, also known as eribulin mesylate, is a chemotherapy medication developed by Eisai Co., Ltd. It is indicated for the treatment of metastatic breast cancer and advanced or metastatic liposarcoma. Here, we will delve into the recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Metastatic Breast Cancer

HALAVEN has been extensively studied in patients with metastatic breast cancer. Key trials include the EMBRACE trial (Study 305) and other pivotal Phase 3 studies (Studies 301 and 304). These studies compared eribulin mesylate with other chemotherapies such as capecitabine, vinorelbine, and Treatment of Physician’s Choice (TPC)[3][5].

  • Overall Survival and Progression-Free Survival: In the EMBRACE trial, patients treated with HALAVEN showed an average overall survival of 13.1 months compared to 10.6 months for those receiving other treatments. In another study, HALAVEN demonstrated similar overall survival and progression-free survival rates compared to capecitabine[5].

  • HER2 Negative Breast Cancer: Post hoc analyses from these trials highlighted the efficacy of eribulin mesylate in patients with HER2-negative metastatic breast cancer, showing promising results in terms of overall survival and progression-free survival[3].

Advanced or Metastatic Liposarcoma

HALAVEN has also shown significant efficacy in treating advanced or metastatic liposarcoma. A Phase III trial demonstrated a 49% reduction in the relative risk of death for patients with liposarcoma compared to the control group. However, there was no evidence of efficacy in patients with advanced or metastatic leiomyosarcoma in this trial[1][5].

Ongoing and Future Clinical Trials

  • Combination Therapies: There is a growing interest in using eribulin mesylate in combination with other agents such as immunotherapy and targeted therapy. Studies are ongoing to evaluate its efficacy in various breast cancer subtypes, including hormone receptor-positive, HER2-positive, and triple-negative breast cancer[4].

  • Other Indications: HALAVEN is under investigation for the treatment of other cancers, including solitary fibrous tumor, metastatic urothelial cell cancer, recurrent or refractory solid tumors, and various types of sarcomas such as rhabdomyosarcoma, non-rhabdomyosarcoma soft tissue sarcoma, and Ewing sarcoma[2].

Market Analysis

Current Market Position

HALAVEN has established itself as a valuable treatment option for patients with metastatic breast cancer and advanced or metastatic liposarcoma. Its approval in these indications has filled a critical need, especially in patient populations with limited treatment options.

  • Competitive Landscape: The market for metastatic breast cancer and soft tissue sarcoma treatments is competitive, with other drugs like capecitabine and vinorelbine. However, HALAVEN's unique mechanism of action and its efficacy in specific patient subgroups have carved out a distinct niche for the drug[5].

Financial Projections

The financial performance of HALAVEN is influenced by several factors, including the number of patients treated, pricing strategies, and the success of ongoing clinical trials.

  • Revenue Growth: Given its established position and ongoing research into new indications, HALAVEN is expected to continue generating significant revenue. The drug's potential in combination therapies and its expansion into other cancer types are likely to drive future growth[2].

Safety and Side Effects

Common Side Effects

HALAVEN is associated with several common side effects, including neutropenia, leucopenia, anemia, reduced appetite, peripheral neuropathy, headache, dyspnea, cough, nausea, constipation, diarrhea, vomiting, alopecia, muscle and joint pain, fatigue, pyrexia, and weight loss. These side effects are consistent with those expected from chemotherapy medications[5].

Regulatory Status

  • Approvals: HALAVEN is approved in various regions, including the European Union and the United States, for the treatment of metastatic breast cancer and advanced or metastatic liposarcoma. Regulatory bodies such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have recognized its efficacy and safety profile[5].

Future Directions

Expanding Indications

Ongoing and planned clinical trials aim to expand the indications for HALAVEN. This includes its use in earlier lines of treatment for breast cancer and its potential in treating other types of sarcomas and solid tumors.

  • Combination Therapies: The integration of HALAVEN with immunotherapy and targeted therapy is a promising area of research. This could enhance its efficacy and open up new treatment options for patients with various types of cancers[4].

Personalized Medicine

The use of pharmacodynamic biomarkers and circulating tumor DNA (ctDNA) dynamics is being explored to better understand the response to HALAVEN and to tailor treatment strategies to individual patients. This approach could improve treatment outcomes and reduce side effects[4].

Key Takeaways

  • Efficacy in Metastatic Breast Cancer and Liposarcoma: HALAVEN has demonstrated significant efficacy in prolonging overall survival and progression-free survival in patients with metastatic breast cancer and advanced or metastatic liposarcoma.
  • Ongoing Clinical Trials: The drug is being investigated in combination therapies and for various other cancer types, which could expand its market and clinical utility.
  • Market Position: HALAVEN holds a distinct position in the market due to its unique mechanism of action and efficacy in specific patient subgroups.
  • Safety Profile: The drug's side effects are consistent with those of other chemotherapy medications, and its safety profile is within what is expected for this class of drugs.
  • Future Directions: Expanding indications, combination therapies, and personalized medicine approaches are key areas for future development.

FAQs

What are the approved indications for HALAVEN?

HALAVEN is approved for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens, and for patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen[1][5].

What are the common side effects of HALAVEN?

Common side effects include neutropenia, leucopenia, anemia, reduced appetite, peripheral neuropathy, headache, dyspnea, cough, nausea, constipation, diarrhea, vomiting, alopecia, muscle and joint pain, fatigue, pyrexia, and weight loss[5].

Is HALAVEN used in combination with other therapies?

Yes, ongoing studies are investigating the use of HALAVEN in combination with immunotherapy and targeted therapy to enhance its efficacy across various breast cancer subtypes and other cancers[4].

What is the current market position of HALAVEN?

HALAVEN has established itself as a valuable treatment option in the market for metastatic breast cancer and advanced or metastatic liposarcoma, filling a critical need in patient populations with limited treatment options[5].

Are there ongoing clinical trials for HALAVEN?

Yes, several ongoing and planned clinical trials are exploring the use of HALAVEN in new indications, combination therapies, and earlier lines of treatment for various cancers[2][4].

Sources

  1. Phase III Trial Results & Efficacy | HALAVEN® (eribulin mesylate) Injection for Advanced Liposarcoma. Halaven.
  2. Net Present Value Model: Halaven - GlobalData. GlobalData.
  3. Eisai Presents Results of Post Hoc Analysis of Eribulin Mesylate. Eisai.
  4. Halaven (eribulin mesylate) News - LARVOL Sigma. LARVOL Sigma.
  5. Halaven | European Medicines Agency (EMA). European Medicines Agency.

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