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Last Updated: April 3, 2025

CLINICAL TRIALS PROFILE FOR ADRIAMYCIN PFS


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505(b)(2) Clinical Trials for Adriamycin Pfs

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial TypeTrial IDTitleStatusSponsorPhaseStart DateSummary
OTC NCT03742258 ↗ Combination Chemotherapy and TAK-659 as Front-Line Treatment in Treating Patients With High-Risk Diffuse Large B Cell Lymphoma Active, not recruiting National Cancer Institute (NCI) Phase 1 2019-03-13 The purpose of this research study is to evaluate a new investigational drug, TAK-659, given in combination with standard chemotherapy, for the treatment of Diffuse Large B-cell Lymphoma (DLBCL). ?Investigational? means that TAK-659 has not been approved by the United States Food and Drug Administration (FDA) for use as a prescription or over-the-counter medication to treat a certain condition. The primary purpose of this study is to find the appropriate and safe dose of the study drug to be used in combination with standard chemotherapy for the treatment of your disease and to determine how well the drug works in treating the disease. Other objectives include measuring the amount of the study drug in the body at different times after taking the study drug. Participation in the study is expected to last for up to 3 years after receiving the last dose of the study drug. Patients will receive the study treatment for up to 18 weeks, as long as they are benefitting.
New Dosage NCT01760226 ↗ Dose Adjusted EPOCH-R, to Treat Mature B Cell Malignancies Completed National Cancer Institute (NCI) Early Phase 1 2013-01-01 The subject is invited to take part in this research study because s/he has been diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), or Post-transplant Lymphoproliferative Disorder (PTLD). In an attempt to improve cure rates while reducing harmful effects from drugs, oncologists are developing new treatment protocols. One such protocol, entitled dose-adjusted EPOCH-R, utilizes two major new strategies. First, the treatment approach utilizes continuous infusion of chemotherapy over four days, instead of being administered over minutes or hours. Secondly, the doses of some medications involved are increased or decreased based on how the drugs affect the subject's ability to produce blood cells, which is used as a measure of how rapidly the body is processing drugs. Using this approach in adults, researchers have shown improved cure rates in these cancers. Additionally, the harmful effects experienced by patients has been mild, with mucositis, severe infections, and tumor lysis syndrome occurring rarely. However, this new dosing method has never been used in children, and the effectiveness and side effects of this new method are unknown in children. The purpose of this study is to look at the safety of dose-adjusted EPOCH-R in the treatment of children with mature B-cell cancers, and to see if we can maintain cure rates (as has been shown in adults). This study represents the first trial of dose-adjusted EPOCH-R in children.
New Dosage NCT01760226 ↗ Dose Adjusted EPOCH-R, to Treat Mature B Cell Malignancies Completed Texas Children's Hospital Early Phase 1 2013-01-01 The subject is invited to take part in this research study because s/he has been diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), or Post-transplant Lymphoproliferative Disorder (PTLD). In an attempt to improve cure rates while reducing harmful effects from drugs, oncologists are developing new treatment protocols. One such protocol, entitled dose-adjusted EPOCH-R, utilizes two major new strategies. First, the treatment approach utilizes continuous infusion of chemotherapy over four days, instead of being administered over minutes or hours. Secondly, the doses of some medications involved are increased or decreased based on how the drugs affect the subject's ability to produce blood cells, which is used as a measure of how rapidly the body is processing drugs. Using this approach in adults, researchers have shown improved cure rates in these cancers. Additionally, the harmful effects experienced by patients has been mild, with mucositis, severe infections, and tumor lysis syndrome occurring rarely. However, this new dosing method has never been used in children, and the effectiveness and side effects of this new method are unknown in children. The purpose of this study is to look at the safety of dose-adjusted EPOCH-R in the treatment of children with mature B-cell cancers, and to see if we can maintain cure rates (as has been shown in adults). This study represents the first trial of dose-adjusted EPOCH-R in children.
New Dosage NCT01760226 ↗ Dose Adjusted EPOCH-R, to Treat Mature B Cell Malignancies Completed Baylor College of Medicine Early Phase 1 2013-01-01 The subject is invited to take part in this research study because s/he has been diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), or Post-transplant Lymphoproliferative Disorder (PTLD). In an attempt to improve cure rates while reducing harmful effects from drugs, oncologists are developing new treatment protocols. One such protocol, entitled dose-adjusted EPOCH-R, utilizes two major new strategies. First, the treatment approach utilizes continuous infusion of chemotherapy over four days, instead of being administered over minutes or hours. Secondly, the doses of some medications involved are increased or decreased based on how the drugs affect the subject's ability to produce blood cells, which is used as a measure of how rapidly the body is processing drugs. Using this approach in adults, researchers have shown improved cure rates in these cancers. Additionally, the harmful effects experienced by patients has been mild, with mucositis, severe infections, and tumor lysis syndrome occurring rarely. However, this new dosing method has never been used in children, and the effectiveness and side effects of this new method are unknown in children. The purpose of this study is to look at the safety of dose-adjusted EPOCH-R in the treatment of children with mature B-cell cancers, and to see if we can maintain cure rates (as has been shown in adults). This study represents the first trial of dose-adjusted EPOCH-R in children.
>Trial Type>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 4 of 4 entries

All Clinical Trials for Adriamycin Pfs

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00000681 ↗ A Phase I Study of the Combination of Recombinant GM-CSF, AZT, and Chemotherapy (ABV) (Adriamycin, Bleomycin, Vincristine) in AIDS and Kaposi's Sarcoma Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 1969-12-31 To determine the safety as well as the most effective dose of sargramostim (GM-CSF; granulocyte-macrophage colony stimulating factor) that will prevent the side effects caused by the combined use of zidovudine (AZT) and various doses of cancer-fighting drugs (doxorubicin, bleomycin, and vincristine) in AIDS patients with Kaposi's sarcoma (KS). Patients included in this study have KS, which is a type of cancer that occurs in nearly 20 percent of patients with AIDS. AIDS patients with extensive KS require treatment with effective cytotoxic (anti-cancer) agents to reduce the tumor size and with antiretroviral agents such as AZT to prevent or ameliorate the development of opportunistic infections. Due to the significant toxic effect of both cytotoxic and antiviral agents on the bone marrow where new blood cells are generated, the combination of these agents is expected to result in complications such as granulocytopenia (very low granulocyte counts). Hematopoietic growth factors such as GM-CSF may reduce the severity and duration of marrow suppression. This may improve survival. Clinical trials of GM-CSF in HIV infected individuals with or without granulocytopenia have shown that the progenitor cells (early blood cells) are responsive to GM-CSF.
NCT00000954 ↗ A Study of Chemotherapy Plus ddI or ddC in the Treatment of AIDS-Related Kaposi's Sarcoma Completed Bristol-Myers Squibb Phase 1 1969-12-31 To determine the toxicity and response to treatment with cytotoxic chemotherapy using doxorubicin (Adriamycin), bleomycin, and vincristine (DBV) for advanced AIDS-related Kaposi's sarcoma in combination with either didanosine (ddI) or zalcitabine (dideoxycytidine; ddC). AIDS patients with extensive Kaposi's sarcoma require treatment with effective cytotoxic agents to reduce the tumor burden, and they also require treatment with other possibly effective antiretroviral agents such as ddI or ddC to ameliorate (delay) the development of opportunistic infections.
NCT00000954 ↗ A Study of Chemotherapy Plus ddI or ddC in the Treatment of AIDS-Related Kaposi's Sarcoma Completed Novum Phase 1 1969-12-31 To determine the toxicity and response to treatment with cytotoxic chemotherapy using doxorubicin (Adriamycin), bleomycin, and vincristine (DBV) for advanced AIDS-related Kaposi's sarcoma in combination with either didanosine (ddI) or zalcitabine (dideoxycytidine; ddC). AIDS patients with extensive Kaposi's sarcoma require treatment with effective cytotoxic agents to reduce the tumor burden, and they also require treatment with other possibly effective antiretroviral agents such as ddI or ddC to ameliorate (delay) the development of opportunistic infections.
NCT00000954 ↗ A Study of Chemotherapy Plus ddI or ddC in the Treatment of AIDS-Related Kaposi's Sarcoma Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 1969-12-31 To determine the toxicity and response to treatment with cytotoxic chemotherapy using doxorubicin (Adriamycin), bleomycin, and vincristine (DBV) for advanced AIDS-related Kaposi's sarcoma in combination with either didanosine (ddI) or zalcitabine (dideoxycytidine; ddC). AIDS patients with extensive Kaposi's sarcoma require treatment with effective cytotoxic agents to reduce the tumor burden, and they also require treatment with other possibly effective antiretroviral agents such as ddI or ddC to ameliorate (delay) the development of opportunistic infections.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 4 of 4 entries

Clinical Trial Conditions for Adriamycin Pfs

Condition Name

8430272600102030405060708090Breast CancerLymphomaSarcomaMultiple Myeloma[disabled in preview]
Condition Name for Adriamycin Pfs
Intervention Trials
Breast Cancer 84
Lymphoma 30
Sarcoma 27
Multiple Myeloma 26
[disabled in preview] 0
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Condition MeSH

15312558560020406080100120140160LymphomaBreast NeoplasmsSarcomaHodgkin Disease[disabled in preview]
Condition MeSH for Adriamycin Pfs
Intervention Trials
Lymphoma 153
Breast Neoplasms 125
Sarcoma 58
Hodgkin Disease 56
[disabled in preview] 0
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Clinical Trial Locations for Adriamycin Pfs

Trials by Country

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Trials by Country for Adriamycin Pfs
Location Trials
Canada 342
Spain 70
Italy 64
Puerto Rico 39
New Zealand 36
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Trials by US State

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Trials by US State for Adriamycin Pfs
Location Trials
Texas 165
New York 130
California 128
Illinois 113
Ohio 106
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Clinical Trial Progress for Adriamycin Pfs

Clinical Trial Phase

29.8%63.2%0050100150200250Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for Adriamycin Pfs
Clinical Trial Phase Trials
Phase 4 17
Phase 3 119
Phase 2/Phase 3 11
[disabled in preview] 252
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Clinical Trial Status

54.4%18.0%16.9%10.7%0406080100120140160180200220240260CompletedActive, not recruitingRecruiting[disabled in preview]
Clinical Trial Status for Adriamycin Pfs
Clinical Trial Phase Trials
Completed 248
Active, not recruiting 82
Recruiting 77
[disabled in preview] 49
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Clinical Trial Sponsors for Adriamycin Pfs

Sponsor Name

trials020406080100120140160180200National Cancer Institute (NCI)M.D. Anderson Cancer CenterChildren's Oncology Group[disabled in preview]
Sponsor Name for Adriamycin Pfs
Sponsor Trials
National Cancer Institute (NCI) 184
M.D. Anderson Cancer Center 51
Children's Oncology Group 35
[disabled in preview] 15
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Sponsor Type

61.2%19.7%19.1%00100200300400500600OtherIndustryNIH[disabled in preview]
Sponsor Type for Adriamycin Pfs
Sponsor Trials
Other 618
Industry 199
NIH 193
[disabled in preview] 0
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Adriamycin PFS (Doxorubicin): Clinical Trials, Market Analysis, and Projections

Introduction

Adriamycin PFS, also known as Doxorubicin, is a potent chemotherapy drug belonging to the anthracycline class. It has been widely used in the treatment of various types of cancer, including breast, lung, leukemia, and lymphoma. Here, we will delve into recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Nivolumab and Doxorubicin in Hodgkin Lymphoma

A significant clinical trial involving Doxorubicin is the NIVAHL trial conducted by the German Hodgkin Study Group (GHSG). This phase II trial combined nivolumab with doxorubicin, vinblastine, and dacarbazine (N-AVD) for early-stage unfavorable Hodgkin lymphoma (HL). The trial reported a high complete remission (CR) rate of 92% and impressive 3-year progression-free survival (PFS) and overall survival (OS) rates of 99% and 100%, respectively[1].

ADCETRIS (Brentuximab Vedotin) Combination in Hodgkin Lymphoma

Another notable trial is the HD21 study, which evaluated the combination of ADCETRIS (brentuximab vedotin) with chemotherapy (etoposide, cyclophosphamide, doxorubicin, dacarbazine, and dexamethasone - BrECADD) in patients with newly diagnosed Stage IIb/III/IV classical Hodgkin lymphoma. This phase 3 trial showed superior PFS and improved tolerability compared to the standard of care regimen (eBEACOPP)[3].

Market Analysis

Global Market Size and Growth

The global Doxorubicin market was valued at USD 989.6 million in 2023 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 6.6% from 2024 to 2030. This growth is driven by the drug's effectiveness in treating various cancers and the ongoing research and development of novel formulations and combination therapies[2].

Regional Market Outlook

  • North America: This region holds the largest market share, with the U.S. and Canada reporting high cancer incidence rates. The U.S. is home to numerous leading cancer research institutions and pharmaceutical companies, which contributes to the market's growth[2].
  • Europe: The European market, particularly the UK, is expected to grow rapidly due to high cancer incidence rates and public health campaigns increasing awareness about advanced cancer therapies[2].
  • Asia Pacific: This region is anticipated to register the fastest CAGR due to increasing healthcare budgets and a high cancer burden. Governments and healthcare systems are investing more in cancer care services, including advanced medications like Doxorubicin[2].

Distribution and Formulation

  • Distribution Channels: Online pharmacies are expected to register the fastest CAGR, offering convenience to patients, especially those with mobility issues or limited access to healthcare facilities[2].
  • Formulations: Lyophilized powder formulations of Doxorubicin are gaining traction due to their stability and proven efficacy. This formulation is less susceptible to degradation, maintaining the drug's potency throughout its shelf life[2].

Market Projections

Future Growth Drivers

The market for Doxorubicin is expected to grow driven by several factors:

  • Research and Development: Ongoing efforts to develop novel formulations and combination therapies will continue to fuel the market. Improved versions of Doxorubicin with reduced side effects and enhanced therapeutic outcomes are being developed[2].
  • Personalized Medicine: The increasing focus on personalized medicine and the rising investments in oncology research will create new opportunities for the Doxorubicin market[2].
  • Cancer Incidence: High cancer incidence rates globally, particularly in regions like North America and Asia Pacific, will continue to drive the demand for effective cancer treatments like Doxorubicin[2].

Challenges and Opportunities

While Doxorubicin remains a crucial drug in cancer treatment, there are challenges to be addressed:

  • Side Effects: Despite its efficacy, Doxorubicin is associated with significant side effects. Ongoing research aims to reduce these adverse effects while maintaining the drug's therapeutic benefits[4].
  • Competition and Innovation: The market is competitive, with other cancer treatments emerging. However, the versatility and effectiveness of Doxorubicin, especially in combination therapies, continue to make it a valuable option[3].

Key Takeaways

  • Clinical Trials: Recent trials like NIVAHL and HD21 have shown promising results for Doxorubicin in combination with other treatments for Hodgkin lymphoma.
  • Market Growth: The global Doxorubicin market is projected to grow at a CAGR of 6.6% from 2024 to 2030, driven by its effectiveness and ongoing research.
  • Regional Markets: North America, Europe, and Asia Pacific are key regions driving the market growth due to high cancer incidence rates and increasing healthcare investments.
  • Formulations and Distribution: Lyophilized powder formulations and online pharmacies are emerging as significant growth drivers.

FAQs

What is the current market size of Doxorubicin?

The global Doxorubicin market was valued at USD 989.6 million in 2023[2].

What is the projected growth rate of the Doxorubicin market?

The market is projected to grow at a CAGR of 6.6% from 2024 to 2030[2].

Which regions are driving the growth of the Doxorubicin market?

North America, Europe, and Asia Pacific are the key regions driving the market growth[2].

What are the main formulations of Doxorubicin?

Lyophilized powder and injection formulations are the main types, with lyophilized powder expected to register the fastest CAGR[2].

What are the primary distribution channels for Doxorubicin?

Hospitals, retail pharmacies, and online pharmacies are the primary distribution channels, with online pharmacies expected to grow the fastest[2].

What are some of the recent clinical trials involving Doxorubicin?

The NIVAHL trial and the HD21 study are recent notable trials involving Doxorubicin in the treatment of Hodgkin lymphoma[1][3].

Sources

  1. Journal of Clinical Oncology: Nivolumab and Doxorubicin, Vinblastine, and Dacarbazine in Early-Stage Unfavorable Hodgkin Lymphoma[1].
  2. Grand View Research: Doxorubicin Market Size, Share And Growth Report, 2030[2].
  3. Pfizer: Takeda and Pfizer Announce Four-Year Results from Positive Phase 3 HD21 Trial of Additional ADCETRIS® (brentuximab vedotin) Combination in Frontline Hodgkin Lymphoma[3].
  4. FDA: Adriamycin RDF® Adriamycin PFS® Label[4].

More… ↓

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