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Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR TOTECT


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All Clinical Trials for Totect

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00016276 ↗ Combination Chemotherapy, Surgery, and Radiation Therapy With or Without Dexrazoxane and Trastuzumab in Treating Women With Stage III or Stage IV Breast Cancer Terminated National Cancer Institute (NCI) Phase 3 2001-05-01 Randomized phase III trial to compare the effectiveness of combination chemotherapy, surgery, and radiation therapy with or without dexrazoxane and trastuzumab in treating women who have stage IIIA, stage IIIB or stage IV breast cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as dexrazoxane, may protect normal cells from the side effects of chemotherapy. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if chemotherapy combined with surgery and radiation therapy is more effective with or without dexrazoxane and trastuzumab in treating breast cancer
NCT00039481 ↗ Oblimersen Plus Combination Chemotherapy and Dexrazoxane in Treating Children and Adolescents With Relapsed or Refractory Solid Tumors Completed National Cancer Institute (NCI) Phase 1 2002-11-01 Phase I trial to study the effectiveness of oblimersen plus combination chemotherapy and dexrazoxane in treating children and adolescents who have relapsed or refractory solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of doxorubicin and cyclophosphamide by making the tumor cells more sensitive to the drug. Chemoprotective drugs such as dexrazoxane may protect normal cells from the side effects of chemotherapy
NCT00084838 ↗ Chemotherapy Combined With Radiation Therapy for Newly Diagnosed CNS AT/RT Completed National Cancer Institute (NCI) Phase 2 2003-02-01 RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving more than one chemotherapy drug with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving intrathecal and systemic combination chemotherapy together with radiation therapy works in treating young patients with newly diagnosed central nervous system (CNS) atypical teratoid/rhabdoid tumors.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Totect

Condition Name

Condition Name for Totect
Intervention Trials
Unspecified Childhood Solid Tumor, Protocol Specific 3
Cardiac Toxicity 2
Acute Myeloid Leukemia 2
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Condition MeSH

Condition MeSH for Totect
Intervention Trials
Leukemia 4
Leukemia, Lymphoid 3
Precursor Cell Lymphoblastic Leukemia-Lymphoma 3
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Clinical Trial Locations for Totect

Trials by Country

Trials by Country for Totect
Location Trials
United States 216
Canada 23
Australia 5
Puerto Rico 4
Germany 2
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Trials by US State

Trials by US State for Totect
Location Trials
California 8
Texas 8
Minnesota 7
Illinois 7
Pennsylvania 7
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Clinical Trial Progress for Totect

Clinical Trial Phase

Clinical Trial Phase for Totect
Clinical Trial Phase Trials
Phase 3 4
Phase 2 2
Phase 1/Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Totect
Clinical Trial Phase Trials
Recruiting 4
Completed 4
Terminated 2
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Clinical Trial Sponsors for Totect

Sponsor Name

Sponsor Name for Totect
Sponsor Trials
National Cancer Institute (NCI) 10
Children's Oncology Group 5
Dana-Farber Cancer Institute 1
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Sponsor Type

Sponsor Type for Totect
Sponsor Trials
NIH 10
Other 8
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Clinical Trials, Market Analysis, and Projections for Totect (Dexrazoxane)

Introduction

Totect, also known as dexrazoxane, is a cytoprotective agent used in the treatment of anthracycline extravasation and to reduce the incidence and severity of cardiomyopathy associated with doxorubicin administration. Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials and Efficacy

Treatment of Anthracycline Extravasation

Clinical trials have demonstrated the efficacy of dexrazoxane in treating anthracycline extravasation. In two prospective, open-label, single-arm, multicentre studies, patients with biopsy-verified anthracycline extravasation were treated with a 3-day schedule of intravenous dexrazoxane. The results showed that dexrazoxane was an effective and well-tolerated acute treatment, with only 1.8% of patients requiring surgical resection[4].

Cardiomyopathy Prevention

In the context of cardiomyopathy prevention, dexrazoxane has been shown to reduce the incidence and severity of cardiac toxicity associated with doxorubicin. However, it is crucial to note that Totect should not be used with the initiation of doxorubicin therapy, as it may interfere with the antitumor activity of the chemotherapy regimen. Instead, it should be used in patients who have received a cumulative doxorubicin dose of 300 mg/m² and are continuing with doxorubicin therapy[1].

Adverse Reactions and Safety Profile

Hematologic Effects

Treatment with Totect is associated with significant hematologic effects, including leukopenia, neutropenia, and thrombocytopenia. These effects can be exacerbated when Totect is used in conjunction with chemotherapeutic agents. Clinical trials have reported grade 2-4 decreased white blood cells, neutrophils, and platelets in patients treated with Totect and cytotoxic chemotherapy[1].

Cardiac and Other Toxicities

While Totect reduces the risk of anthracycline-induced cardiac toxicity, it does not completely eliminate it. Monitoring of cardiac function is necessary before and during therapy to assess left ventricular ejection fraction (LVEF). Additionally, Totect can cause fetal harm and requires careful consideration in pregnant women and those of reproductive potential[1].

Market Analysis

Current Market Landscape

The market for drugs treating conditions related to chemotherapy, such as cardiomyopathy and extravasation, is part of the broader oncology market. The global oncology market is driven by the increasing incidence of cancer and the need for effective treatments.

Non-Small Cell Lung Cancer (NSCLC) Market Context

Although Totect is not specifically used for NSCLC, the broader oncology market trends are relevant. The NSCLC market is expected to grow significantly, driven by the increasing incorporation of premium-priced immunotherapies and targeted therapies. By 2025, the NSCLC market is projected to reach $26.8 billion, with immunotherapies accounting for approximately 65% of total sales[2].

Market Projections for Totect

Growth Drivers

The demand for Totect is likely to be driven by several factors:

  • Increasing Use of Anthracyclines: As anthracyclines remain a cornerstone in various chemotherapy regimens, the need for effective treatments to manage their side effects, such as extravasation and cardiomyopathy, will continue.
  • Advancements in Oncology: The growing focus on personalized and targeted therapies may lead to increased use of drugs like Totect that mitigate specific side effects of chemotherapy.

Market Barriers

Despite these drivers, there are several barriers to growth:

  • Competition from Alternative Treatments: The development of new chemotherapeutic agents with fewer side effects could reduce the reliance on Totect.
  • Regulatory and Safety Concerns: The need for careful monitoring and the potential for adverse reactions may limit the widespread adoption of Totect[1].

Regional Market Outlook

Global Trends

The global clinical trials market, which includes trials for drugs like Totect, is expected to grow at a CAGR of 7.1% from 2024 to 2032. This growth is driven by the increasing prevalence of chronic diseases and the need for new treatments[3].

Regional Variations

  • North America and Europe: These regions have a significant market share in clinical trials and drug development. However, the growth in these regions is expected to be moderate compared to emerging markets.
  • Asia Pacific: This region is expected to expand at the fastest CAGR due to the increasing prevalence of infectious and chronic diseases, driving the demand for new drugs and clinical trials[3].

Key Takeaways

  • Efficacy in Clinical Trials: Totect has been shown to be effective in treating anthracycline extravasation and reducing cardiomyopathy associated with doxorubicin.
  • Safety Profile: The drug is associated with significant hematologic and cardiac effects, necessitating careful monitoring.
  • Market Growth Drivers: Increasing use of anthracyclines and advancements in oncology are expected to drive demand.
  • Market Barriers: Competition from alternative treatments and regulatory concerns may limit growth.
  • Regional Outlook: The Asia Pacific region is expected to see the fastest growth in the clinical trials and drug development market.

FAQs

What is Totect used for?

Totect (dexrazoxane) is used for the treatment of extravasation resulting from intravenous anthracycline chemotherapy and for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration.

What are the common adverse reactions associated with Totect?

Common adverse reactions include leukopenia, neutropenia, thrombocytopenia, and cardiac toxicity. Febrile neutropenia can also occur in some patients.

Can Totect be used with the initiation of doxorubicin therapy?

No, Totect should not be used with the initiation of doxorubicin therapy as it may interfere with the antitumor activity of the chemotherapy regimen. It should be used in patients who have received a cumulative doxorubicin dose of 300 mg/m² and are continuing with doxorubicin therapy.

How does Totect affect cardiac function?

Totect reduces the risk of anthracycline-induced cardiac toxicity but does not completely eliminate it. Monitoring of cardiac function is necessary before and during therapy.

Is Totect safe for use in pregnant women?

Totect can cause fetal harm and is not recommended for use in pregnant women. Effective contraception is advised during treatment and for a specified period after the last dose.

Sources

  1. FDA Label for Totect: "Totect (dexrazoxane) for injection, for intravenous use" - accessdata.fda.gov
  2. GlobalData NSCLC Market Forecast: "NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025" - drug-dev.com
  3. Fortune Business Insights Clinical Trials Market Report: "Clinical Trials Market SIZE, SHARE | GROWTH REPORT [2032]" - fortunebusinessinsights.com
  4. PubMed Study on Dexrazoxane: "Treatment of anthracycline extravasation with Savene (dexrazoxane)" - pubmed.ncbi.nlm.nih.gov

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