CLINICAL TRIALS PROFILE FOR ZINECARD

All Clinical Trials for ZINECARD

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00003937 ↗	Combination Chemotherapy Plus Dexrazoxane in Treating Patients With Newly Diagnosed Nonmetastatic Osteosarcoma	Completed	National Cancer Institute (NCI)	Phase 3	1999-09-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Chemoprotective drugs such as dexrazoxane may protect normal cells from the side effects of chemotherapy. PURPOSE: Phase III trial to study the effectiveness of three combination chemotherapy regimens plus dexrazoxane in treating patients who have newly diagnosed nonmetastatic osteosarcoma.
NCT00003937 ↗	Combination Chemotherapy Plus Dexrazoxane in Treating Patients With Newly Diagnosed Nonmetastatic Osteosarcoma	Completed	Children's Oncology Group	Phase 3	1999-09-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Chemoprotective drugs such as dexrazoxane may protect normal cells from the side effects of chemotherapy. PURPOSE: Phase III trial to study the effectiveness of three combination chemotherapy regimens plus dexrazoxane in treating patients who have newly diagnosed nonmetastatic osteosarcoma.
NCT00005578 ↗	Combination Chemotherapy With or Without Dexrazoxane in Treating Children With Hodgkin's Disease	Completed	National Cancer Institute (NCI)	Phase 3	1997-03-01	RATIONALE: 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. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without dexrazoxane in treating children who have Hodgkin's disease.
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 ZINECARD

Condition Name

Condition Name for ZINECARD
Intervention	Trials
Cardiac Toxicity	6
Unspecified Childhood Solid Tumor, Protocol Specific	3
Sarcoma	3
Lymphoma	3

Condition MeSH

Condition MeSH for ZINECARD
Intervention	Trials
Leukemia	8
Precursor Cell Lymphoblastic Leukemia-Lymphoma	7
Leukemia, Lymphoid	7
Cardiotoxicity	6

Clinical Trial Locations for ZINECARD

Trials by Country

+

−

Trials by Country for ZINECARD
Location	Trials
United States	374
Canada	43
Australia	9
Puerto Rico	6
Switzerland	3

Trials by US State

+

−

Trials by US State for ZINECARD
Location	Trials
Texas	18
California	13
New York	13
Illinois	12
Tennessee	12

Clinical Trial Progress for ZINECARD

Clinical Trial Phase

Clinical Trial Phase for ZINECARD
Clinical Trial Phase	Trials
Phase 3	9
Phase 2	5
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for ZINECARD
Clinical Trial Phase	Trials
Completed	11
Recruiting	7
Terminated	7

Clinical Trial Sponsors for ZINECARD

Sponsor Name

Sponsor Name for ZINECARD
Sponsor	Trials
National Cancer Institute (NCI)	15
Children's Oncology Group	10
M.D. Anderson Cancer Center	4

Sponsor Type

Sponsor Type for ZINECARD
Sponsor	Trials
Other	31
NIH	15
Industry	7

ZINECARD: Clinical Trials, Market Analysis, and Projections

Introduction to ZINECARD

ZINECARD, also known as dexrazoxane, is a cytoprotective agent used primarily to reduce the incidence and severity of cardiomyopathy associated with the use of anthracyclines, such as doxorubicin, in cancer patients. Here, we will delve into the clinical trials, market analysis, and projections for this crucial drug.

Clinical Trials and Efficacy

Purpose and Indications

ZINECARD is indicated for patients who have received a cumulative doxorubicin dose of 300 mg/m² and are continuing with doxorubicin therapy. It is not recommended for use with the initiation of chemotherapy, as it may interfere with the antitumor activity of the chemotherapy regimen[1][4].

Key Findings

Clinical trials have shown that patients receiving ZINECARD had significantly smaller mean decreases from baseline in left ventricular ejection fraction (LVEF) and lower incidences of congestive heart failure compared to the control group. However, treatment with ZINECARD does not completely eliminate the risk of anthracycline-induced cardiac toxicity, necessitating regular monitoring of cardiac function[1].

Adverse Reactions

Patients in clinical trials who received ZINECARD along with the FAC chemotherapy regimen (fluorouracil, doxorubicin, and cyclophosphamide) experienced more severe leukopenia, granulocytopenia, and thrombocytopenia compared to those receiving FAC without ZINECARD. Other notable adverse reactions include pain on injection, nausea, vomiting, fatigue, and anorexia[1].

Market Analysis

Current Market Size

The global dexrazoxane market, which includes ZINECARD, was valued at approximately $768 million in 2023. This market is segmented by product type (250mg and 500mg) and by end-user (hospitals and drugstores), with hospitals expected to have the largest growth rate due to their direct delivery of the drug[2][5].

Growth Drivers

The market growth for dexrazoxane is driven by several factors, including the increasing prevalence of cancer globally. The rise in cancer cases has led to a higher demand for drugs that mitigate the side effects of chemotherapy, such as cardiomyopathy associated with doxorubicin use. Additionally, advancements in healthcare and increased government initiatives supporting clinical trials contribute to market expansion[5].

Regional Analysis

The dexrazoxane market is segmented into five major regions: North America, Europe, Asia Pacific, Latin America, and the Middle East. Each region is expected to contribute to the overall growth, with hospitals being the primary end-users due to their integrated pharmacies and direct drug delivery systems[5].

Market Projections

Forecasted Market Size

The global dexrazoxane market is anticipated to reach $1.085 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 5.1% during the forecast period from 2024 to 2030[2].

Competitive Landscape

The market for dexrazoxane includes several key players such as Bedford Laboratories, Topotarget, Pharmacia and Upjohn, Gland Pharma, Mylan, West-Ward Pharms, Clinigen, Boehringer Ingelheim, and Aosaikang Pharmaceutical. These companies are expected to drive innovation and competition in the market, contributing to its growth[2].

Impact of Clinical Trials on Market Growth

Role of Clinical Trials

Clinical trials play a crucial role in the development and approval of drugs like ZINECARD. These trials ensure the safety, efficacy, and effectiveness of new treatments before they are widely available. The increasing number of clinical trials, particularly in the area of cancer treatment, drives the demand for protective agents like dexrazoxane[3].

Phases of Clinical Trials

Clinical trials for drugs like ZINECARD typically go through four phases: Phase I assesses safety and dosage, Phase II evaluates safety and efficacy in a larger group, Phase III confirms effectiveness and monitors side effects in even larger populations, and Phase IV gathers additional data post-FDA approval. Each phase is critical for advancing medical knowledge and improving patient care[3].

Pharmacokinetics and Special Considerations

Renal Impairment

The pharmacokinetics of dexrazoxane have shown that clearance is reduced in subjects with renal dysfunction. For patients with moderate to severe renal impairment, dosing may need to be adjusted to achieve equivalent exposure compared to patients with normal renal function[1].

Hepatic Impairment

The pharmacokinetics of ZINECARD have not been evaluated in patients with hepatic impairment. However, the dose of ZINECARD is dependent on the dose of doxorubicin, which must be carefully managed[1].

Conclusion

ZINECARD is a vital drug in the management of cardiomyopathy associated with anthracycline use, particularly in cancer patients. The clinical trials have demonstrated its efficacy in reducing cardiac toxicity, although it also comes with its own set of adverse reactions. The market for dexrazoxane is expected to grow significantly, driven by the increasing prevalence of cancer and advancements in healthcare.

Key Takeaways

• ZINECARD is indicated for reducing cardiomyopathy in patients receiving cumulative doxorubicin doses.
• Clinical trials show reduced cardiac toxicity but increased risk of certain adverse reactions.
• The global dexrazoxane market is projected to reach $1.085 billion by 2030.
• Market growth is driven by the increasing prevalence of cancer and healthcare advancements.
• Key players include Bedford Laboratories, Topotarget, and others.

FAQs

Q: What is the primary indication for ZINECARD?

A: ZINECARD is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m² and will continue to receive doxorubicin therapy[1][4].

Q: Can ZINECARD be used with the initiation of chemotherapy?

A: No, ZINECARD should not be used with the initiation of chemotherapy as it may interfere with the antitumor activity of the chemotherapy regimen[1][4].

Q: What are the common adverse reactions associated with ZINECARD?

A: Common adverse reactions include pain on injection, nausea, vomiting, fatigue, anorexia, stomatitis, fever, infection, and diarrhea. Severe leukopenia, granulocytopenia, and thrombocytopenia are also observed[1].

Q: How does renal impairment affect the dosing of ZINECARD?

A: For patients with moderate to severe renal impairment, the dosing of ZINECARD may need to be reduced by 50% to achieve equivalent exposure compared to patients with normal renal function[1].

Q: What is the forecasted market size for dexrazoxane by 2030?

A: The global dexrazoxane market is anticipated to reach $1.085 billion by 2030, growing at a CAGR of 5.1% during the forecast period from 2024 to 2030[2].

Sources

1. Pfizer: Zinecard - Pfizer. [Labeling Information]
2. Valuates Reports: Global Dexrazoxane Market Research Report 2023.
3. Straits Research: Global Clinical Trials Market Size, Top Share, Trends, Forecast by 2024-2033.
4. FDA: Zinecard® (dexrazoxane for injection) 250 mg - FDA. [Labeling Information]
5. Research and Markets: Global Dexrazoxane Market Outlook 2028.