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Last Updated: February 16, 2025

CLINICAL TRIALS PROFILE FOR COSMEGEN


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All Clinical Trials for Cosmegen

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00002610 ↗ Chemotherapy With or Without Surgery, Radiation Therapy, or Stem Cell Transplantation in Treating Young Patients With Kidney Tumors Completed National Cancer Institute (NCI) Phase 3 1996-01-01 RATIONALE: Drugs used in chemotherapy use 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. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known which therapy regimen is most effective for treating patients with kidney tumors. PURPOSE: Phase III trial to compare the effectiveness of chemotherapy with or without radiation therapy, surgery, and/or peripheral stem cell or bone marrow transplantation in treating young patients with kidney tumors.
NCT00002610 ↗ Chemotherapy With or Without Surgery, Radiation Therapy, or Stem Cell Transplantation in Treating Young Patients With Kidney Tumors Completed Children's Oncology Group Phase 3 1996-01-01 RATIONALE: Drugs used in chemotherapy use 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. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known which therapy regimen is most effective for treating patients with kidney tumors. PURPOSE: Phase III trial to compare the effectiveness of chemotherapy with or without radiation therapy, surgery, and/or peripheral stem cell or bone marrow transplantation in treating young patients with kidney tumors.
NCT00003702 ↗ Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia Completed Eastern Cooperative Oncology Group Phase 3 1999-06-01 Randomized phase III trial to compare the effectiveness of methotrexate with that of dactinomycin in treating patients who have gestational trophoblastic neoplasia. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether methotrexate is more effective than dactinomycin in treating patients with gestational trophoblastic neoplasia.
NCT00003702 ↗ Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia Completed National Cancer Institute (NCI) Phase 3 1999-06-01 Randomized phase III trial to compare the effectiveness of methotrexate with that of dactinomycin in treating patients who have gestational trophoblastic neoplasia. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether methotrexate is more effective than dactinomycin in treating patients with gestational trophoblastic neoplasia.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cosmegen

Condition Name

Condition Name for Cosmegen
Intervention Trials
Embryonal Rhabdomyosarcoma 3
Rhabdomyosarcoma 3
Adult Rhabdomyosarcoma 3
Botryoid-Type Embryonal Rhabdomyosarcoma 2
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Condition MeSH

Condition MeSH for Cosmegen
Intervention Trials
Rhabdomyosarcoma 8
Rhabdomyosarcoma, Embryonal 6
Rhabdomyosarcoma, Alveolar 4
Sarcoma 4
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Clinical Trial Locations for Cosmegen

Trials by Country

Trials by Country for Cosmegen
Location Trials
United States 458
Canada 73
Australia 37
New Zealand 13
Japan 8
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Trials by US State

Trials by US State for Cosmegen
Location Trials
Texas 13
California 12
Ohio 12
North Carolina 12
Tennessee 12
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Clinical Trial Progress for Cosmegen

Clinical Trial Phase

Clinical Trial Phase for Cosmegen
Clinical Trial Phase Trials
Phase 3 13
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Cosmegen
Clinical Trial Phase Trials
Completed 6
Recruiting 3
Active, not recruiting 2
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Clinical Trial Sponsors for Cosmegen

Sponsor Name

Sponsor Name for Cosmegen
Sponsor Trials
National Cancer Institute (NCI) 14
Children's Oncology Group 10
Gynecologic Oncology Group 2
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Sponsor Type

Sponsor Type for Cosmegen
Sponsor Trials
Other 16
NIH 14
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COSMEGEN: Clinical Trials, Market Analysis, and Projections

Introduction

COSMEGEN, also known as dactinomycin, is a potent chemotherapeutic agent used in the treatment of various cancers, including Wilms’ tumor, childhood rhabdomyosarcoma, and certain types of sarcomas. This article provides an update on the clinical trials, market analysis, and projections for COSMEGEN.

Clinical Trials and Efficacy

Wilms’ Tumor

Clinical studies, particularly the National Wilms’ Tumor Studies (NWTS-3 and NWTS-4), have extensively evaluated the efficacy of COSMEGEN in treating Wilms’ tumor. These studies involved large patient cohorts and various treatment regimens incorporating COSMEGEN. For example, NWTS-4 evaluated outcomes in 1,687 patients with favorable histology, showing high relapse-free survival and overall survival rates across different stages and treatment regimens[1][5].

Childhood Rhabdomyosarcoma

The Third Intergroup Rhabdomyosarcoma Study (IRS-III) demonstrated the effectiveness of COSMEGEN in childhood rhabdomyosarcoma. This study involved 1,062 patients and showed that relapses were uncommon, with a significant percentage of patients categorized as alive without evidence of disease over the four-year study period[1].

Ewing’s Sarcoma

COSMEGEN has also been used in the management of Ewing’s sarcoma, both in metastatic and non-metastatic cases. Studies in the UK have shown that patients treated with COSMEGEN as part of maintenance therapy had favorable outcomes, with a significant percentage remaining free of disease at five years[1].

Market Analysis

Market Size and Forecast

The dactinomycin market, which includes COSMEGEN, was valued at USD 6.9 billion in 2023 and is projected to reach USD 7.81 billion by 2031, growing at a CAGR of 8.27% during the forecast period of 2024-2030. This growth is driven by several factors, including the rising incidence of cancers, advancements in cancer treatment protocols, and an aging population[2].

Key Drivers

  • Rising Incidence of Cancers: The global increase in cancer cases is a significant driver for the demand of effective cancer treatments like COSMEGEN.
  • Advancements in Cancer Treatment Protocols: Ongoing research and clinical trials are likely to expand the therapeutic applications of COSMEGEN.
  • Aging Population: The growing and aging population contributes to an increase in cancer diagnoses, boosting the demand for COSMEGEN.
  • Increased R&D Investment: Pharmaceutical companies are investing heavily in research and development for innovative cancer therapies, including those involving COSMEGEN[2].

Market Segmentation

The market can be segmented by application, end-user, formulation, and geography. North America and Europe are prominent markets due to advanced healthcare infrastructure and extensive research activities. The Asia-Pacific region is also witnessing rapid growth, driven by a large patient population and improving healthcare facilities[2].

Challenges and Limitations

Regulatory Challenges

The approval process for new drugs or generics can be lengthy and complicated, potentially delaying market entry and affecting supply.

  • High Development Costs: The costs associated with research, development, and clinical trials are substantial, which may deter companies from investing heavily in COSMEGEN[2].

Competition from Other Therapies

The cancer treatment market is highly competitive, with newer therapies offering better efficacy, fewer side effects, or more convenient administration routes, which could reduce the demand for COSMEGEN.

  • Side Effects and Toxicity: COSMEGEN has notable side effects, which can limit its use in certain patient populations and impact its market growth[2].

Pricing Pressure

Healthcare cost containment measures, including price negotiations and insurance coverage limitations, can affect the profitability of COSMEGEN, especially in markets with strict pricing regulations[2].

Future Projections

Growing Demand

The demand for COSMEGEN is expected to grow due to the increasing prevalence of cancers and advancements in cancer treatment protocols. The market is also driven by supportive government policies and educational initiatives aimed at improving cancer treatment outcomes[2].

Emerging Markets

The Asia-Pacific region, including countries like India and China, is expected to play a significant role in the future growth of the COSMEGEN market. These regions are characterized by large patient populations, improving healthcare facilities, and increasing investments in oncology research[2].

Innovations in Treatment Protocols

Ongoing research and clinical trials may lead to new applications and combinations of COSMEGEN with other therapies, further increasing its usage in oncology treatment protocols. The integration of omics technologies in clinical trials is also expected to enhance the efficacy and safety of COSMEGEN and other cancer treatments[4].

Key Takeaways

  • Clinical Efficacy: COSMEGEN has shown significant efficacy in treating Wilms’ tumor, childhood rhabdomyosarcoma, and Ewing’s sarcoma through various clinical trials.
  • Market Growth: The dactinomycin market, including COSMEGEN, is projected to grow at a CAGR of 8.27% from 2024 to 2030.
  • Key Drivers: Rising cancer incidence, advancements in treatment protocols, and an aging population are key drivers of market growth.
  • Challenges: Regulatory challenges, high development costs, competition from other therapies, and pricing pressure are significant limitations.
  • Future Projections: Emerging markets, especially in the Asia-Pacific region, and innovations in treatment protocols are expected to drive future growth.

FAQs

What is COSMEGEN used for?

COSMEGEN (dactinomycin) is used in the treatment of various cancers, including Wilms’ tumor, childhood rhabdomyosarcoma, and certain types of sarcomas.

What are the key drivers of the COSMEGEN market?

The key drivers include the rising incidence of cancers, advancements in cancer treatment protocols, an aging population, and increased R&D investment.

What are the challenges facing the COSMEGEN market?

Challenges include regulatory hurdles, high development costs, competition from other therapies, side effects and toxicity, and pricing pressure.

How is the COSMEGEN market expected to grow?

The market is projected to grow at a CAGR of 8.27% from 2024 to 2030, reaching USD 7.81 billion by 2031.

Which regions are expected to drive the future growth of the COSMEGEN market?

The Asia-Pacific region, particularly countries like India and China, is expected to play a significant role in future market growth due to large patient populations and improving healthcare facilities.

Sources

  1. FDA Label for Cosmegen: "Cosmegen® for Injection (dactinomycin for injection) (Actinomycin D)" - FDA.
  2. Dactinomycin Market Report: "Dactinomycin Market Size, Share, Scope, Trends And Forecast" - Verified Market Research.
  3. Global Sarcoma Drugs Market Report: "Global Sarcoma Drugs Market Report 2024" - The Business Research Company.
  4. Omics-based Clinical Trials Market: "Omics-based Clinical Trials Market Size to Hit USD 70.92 Billion by 2034" - Biospace.
  5. Cosmegen Product Monograph: "Cosmegen Product Monograph" - Recordati Rare Diseases.

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