CLINICAL TRIALS PROFILE FOR DEXRAZOXANE HYDROCHLORIDE

All Clinical Trials for DEXRAZOXANE HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00003667 ↗	Combination Chemotherapy and Biological Therapy in Treating Patients With High-Risk Ewing's Sarcoma	Completed	National Cancer Institute (NCI)	Phase 2	1998-09-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining chemotherapy with biological therapy may kill more tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy with or without biological therapy in treating patients who have newly diagnosed high-risk Ewing's sarcoma.
NCT00002827 ↗	Chemotherapy Followed by Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin's Disease	Completed	Children's Cancer Group	Phase 3	1996-10-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy with radiation therapy may kill more cancer cells. It is not yet known if chemotherapy is more effective with or without dexrazoxane for Hodgkin's disease. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy, with or without dexrazoxane, followed by radiation therapy in treating young patients with newly diagnosed stage I, stage II, or stage III Hodgkin's disease.
NCT00002827 ↗	Chemotherapy Followed by Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin's Disease	Completed	National Cancer Institute (NCI)	Phase 3	1996-10-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy with radiation therapy may kill more cancer cells. It is not yet known if chemotherapy is more effective with or without dexrazoxane for Hodgkin's disease. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy, with or without dexrazoxane, followed by radiation therapy in treating young patients with newly diagnosed stage I, stage II, or stage III Hodgkin's disease.
NCT00002827 ↗	Chemotherapy Followed by Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin's Disease	Completed	Children's Oncology Group	Phase 3	1996-10-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy with radiation therapy may kill more cancer cells. It is not yet known if chemotherapy is more effective with or without dexrazoxane for Hodgkin's disease. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy, with or without dexrazoxane, followed by radiation therapy in treating young patients with newly diagnosed stage I, stage II, or stage III Hodgkin's disease.

Clinical Trial Conditions for DEXRAZOXANE HYDROCHLORIDE

Condition Name

Condition Name for DEXRAZOXANE HYDROCHLORIDE
Intervention	Trials
Sarcoma	9
Cardiac Toxicity	7
Acute Myeloid Leukemia	6
Acute Lymphoblastic Leukemia	4

Condition MeSH

Condition MeSH for DEXRAZOXANE HYDROCHLORIDE
Intervention	Trials
Leukemia	17
Sarcoma	12
Precursor Cell Lymphoblastic Leukemia-Lymphoma	12
Leukemia, Lymphoid	12

Clinical Trial Locations for DEXRAZOXANE HYDROCHLORIDE

Trials by Country

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Trials by Country for DEXRAZOXANE HYDROCHLORIDE
Location	Trials
United States	575
Canada	72
Australia	22
Puerto Rico	11
New Zealand	7

Trials by US State

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Trials by US State for DEXRAZOXANE HYDROCHLORIDE
Location	Trials
Texas	25
New York	24
California	21
Massachusetts	20
Tennessee	20

Clinical Trial Progress for DEXRAZOXANE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for DEXRAZOXANE HYDROCHLORIDE
Clinical Trial Phase	Trials
Phase 3	18
Phase 2/Phase 3	3
Phase 2	17

Clinical Trial Status

Clinical Trial Status for DEXRAZOXANE HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	21
Terminated	14
Recruiting	11

Clinical Trial Sponsors for DEXRAZOXANE HYDROCHLORIDE

Sponsor Name

Sponsor Name for DEXRAZOXANE HYDROCHLORIDE
Sponsor	Trials
National Cancer Institute (NCI)	27
Children's Oncology Group	12
Dana-Farber Cancer Institute	6

Sponsor Type

Sponsor Type for DEXRAZOXANE HYDROCHLORIDE
Sponsor	Trials
Other	69
NIH	27
Industry	11

Dexrazoxane Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Dexrazoxane hydrochloride, a small molecule drug with antimitotic and immunosuppressive properties, has been a significant player in the field of oncology, particularly in protecting against the cardiotoxic effects of anthracycline chemotherapy. Here, we delve into the current clinical trials, market analysis, and future projections for this crucial drug.

Clinical Trials Update

Current Trials and Objectives

Several clinical trials are ongoing to optimize the use of dexrazoxane hydrochloride. One notable trial, conducted by the Children's Oncology Group, investigates the effects of dexrazoxane hydrochloride on biomarkers associated with cardiomyopathy and heart failure after cancer treatment. This trial involves assessing blood samples to understand how dexrazoxane affects cellular responses and patient outcomes[1].

Another significant trial, initiated by the University of Arkansas for Medical Sciences (UAMS), focuses on determining the most effective dose and timing for dexrazoxane administration prior to doxorubicin in healthy women. This phase 1 trial aims to protect the heart from doxorubicin's side effects without compromising its cancer-fighting efficacy. The trial's findings suggest that administering dexrazoxane eight hours before doxorubicin could be a breakthrough in minimizing heart damage[3].

Trial Phases and Participants

The UAMS trial is currently in its phase 1 stage, with plans to move to phase 2 (Phoenix 2 Trial) to evaluate the efficacy of dexrazoxane pre-treatment in preventing heart damage in breast cancer patients. Future trials may also include other types of cancers, such as sarcoma and pediatric leukemia[3].

Mechanism and Therapeutic Areas

Cardioprotection

Dexrazoxane hydrochloride is renowned for its cardioprotective properties, specifically against the toxicity induced by anthracyclines like doxorubicin. It inhibits the formation of a toxic iron-anthracycline complex, thereby reducing the risk of cardiomyopathy and heart failure[5].

Indications

The drug is approved for several indications, including the prevention and reduction of cardiomyopathy caused by anthracycline, metastatic breast cancer, and the treatment of extravasation of diagnostic and therapeutic materials[4].

Market Analysis

Global Market Outlook

The global dexrazoxane market is anticipated to experience significant growth due to the increasing incidence of cancer and the subsequent rise in the use of anthracyclines. The market is projected to record a substantial CAGR from 2023 to 2029, driven by advancements in healthcare and the necessity of cardioprotective agents in cancer treatment[2][5].

Regional Segmentation

The market is segmented into major regions including North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa. North America and Europe hold significant shares due to the presence of advanced cancer treatment institutions and improved healthcare facilities. The Asia-Pacific region, particularly countries like China and India, is expected to exhibit vital growth due to government initiatives aimed at enhancing healthcare infrastructure[2].

Product and End-User Segmentation

The dexrazoxane market is segmented by product type (250mg and 500mg) and by end-user type (hospitals and drugstores). Hospitals are expected to dominate the market, given their direct delivery of medications through in-house pharmacies[2].

Key Manufacturers and Market Share

Major players in the dexrazoxane market include Bedford Laboratories, Topotarget, Pharmacia and Upjohn, Gland Pharma, Mylan, West-Ward Pharms, Clinigen, and Boehringer Ingelheim. These companies collectively account for a significant portion of the market revenue, with the top three vendors holding a substantial market share[5].

Growth Drivers

Increasing Cancer Incidence

The rising number of cancer patients globally has led to an increased use of anthracyclines, thereby driving the demand for dexrazoxane as a cardioprotective agent[2].

FDA Approval and Orphan Drug Status

Dexrazoxane's FDA approval and designation as an orphan drug for preventing anthracycline-induced cardiomyopathy have further boosted its market growth[5].

Advancements in Healthcare

Improvements in healthcare facilities and the successful implementation of dexrazoxane in medical practice have contributed to its market expansion[2].

Challenges and Future Directions

Balancing Cardioprotection and Cancer Treatment Efficacy

One of the primary challenges is ensuring that dexrazoxane does not undermine the efficacy of doxorubicin in treating cancer. Ongoing trials, such as the UAMS study, aim to address this issue by optimizing the timing and dosage of dexrazoxane administration[3].

Expanding Indications

Future research may explore the use of dexrazoxane in other types of cancers and its potential in preventing other forms of chemotherapy-induced toxicity.

Key Takeaways

• Dexrazoxane hydrochloride is a crucial drug in preventing cardiomyopathy and heart failure associated with anthracycline chemotherapy.
• Ongoing clinical trials are focused on optimizing the dose and timing of dexrazoxane administration to maximize cardioprotection without compromising cancer treatment efficacy.
• The global market for dexrazoxane is expected to grow significantly due to the increasing incidence of cancer and advancements in healthcare.
• Key manufacturers and regional markets play a vital role in the market's growth and segmentation.

FAQs

What is the primary use of dexrazoxane hydrochloride in cancer treatment?

Dexrazoxane hydrochloride is primarily used to prevent cardiomyopathy and heart failure caused by anthracycline chemotherapy.

Which regions are expected to drive the growth of the dexrazoxane market?

North America and Europe are currently leading the market, but the Asia-Pacific region is expected to exhibit significant growth due to government initiatives and improving healthcare infrastructure.

What are the key challenges in using dexrazoxane hydrochloride?

The main challenge is ensuring that dexrazoxane does not interfere with the cancer-fighting efficacy of doxorubicin while providing cardioprotection.

Who are the major players in the dexrazoxane market?

Major players include Bedford Laboratories, Topotarget, Pharmacia and Upjohn, Gland Pharma, Mylan, West-Ward Pharms, Clinigen, and Boehringer Ingelheim.

What is the current status of clinical trials involving dexrazoxane hydrochloride?

Several clinical trials are ongoing, with a notable phase 1 trial at UAMS aimed at determining the optimal dose and timing of dexrazoxane administration prior to doxorubicin.

Sources

1. NCI Clinical Trials: Effects of Dexrazoxane Hydrochloride on Biomarkers Associated With Cardiomyopathy and Heart Failure After Cancer Treatment.
2. Research and Markets: Global Dexrazoxane Market Outlook 2028.
3. UAMS News: UAMS’ First Phase 1 Cancer Clinical Trial Testing New Way to Protect Hearts while Treating Cancer.
4. Patsnap: Dexrazoxane Hydrochloride - Drug Targets, Indications, Patents.
5. OpenPR: Dexrazoxane Market outlook, analysis, Research Report 2023.