CLINICAL TRIALS PROFILE FOR DACARBAZINE

505(b)(2) Clinical Trials for dacarbazine

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT05068453 ↗	Study of Oncolytic Virus in Combination With HX-008 and Radiotherapy in Melanoma Patients With Liver Metastasis	Not yet recruiting	Beijing Cancer Hospital	Phase 1	2021-10-01	Malignant melanoma, is a kind of malignant tumor derived from melanocytes. It is common in skin, mucous membrane, eye choroid and other parts. Melanoma is one of the fastest growing malignant tumors with an annual incidence rate of 3-5%. In 2012, there were 232000 new cases of melanoma and 55000 deaths worldwide. Though, the incidence rate of melanoma is relatively low in China, it has been increasing rapidly in recent years. Melanoma has seriously endangering the health of Chinese people. Patients with stage Ⅳ melanoma have a poor prognosis. According to statistics, the median survival time of stage M1a melanoma is 15 months, while stage M1b is 8 months. The median survival time of bone metastasis melanoma is 6 months, while liver and brain metastasis is 4 months. The overall median survival time of metastatic melanoma is only 7.5 months, and the 2-year survival rate is 15%. For patients with advanced melanoma, dacarbazine is the only chemotherapy drug approved by NMPA, but its overall effective rate is only 13.4%, and the median survival time is 5.6 ~ 11 months. Therapies(new drugs or new combination treatments)with higher remission rate and longer survival are urgently needed for patients with advanced melanoma.
New Combination	NCT05070221 ↗	Study of Oncolytic Virus in Combination With HX-008 and Axitinib in Melanoma Patients With Liver Metastasis	Not yet recruiting	Beijing Cancer Hospital	Phase 1	2021-10-01	Malignant melanoma, is a kind of malignant tumor derived from melanocytes. It is common in skin, mucous membrane, eye choroid and other parts. Melanoma is one of the fastest growing malignant tumors with an annual incidence rate of 3-5%. In 2012, there were 232000 new cases of melanoma and 55000 deaths worldwide. Though, the incidence rate of melanoma is relatively low in China, it has been increasing rapidly in recent years. Melanoma has seriously endangering the health of Chinese people. Patients with stage Ⅳ melanoma have a poor prognosis. According to statistics, the median survival time of stage M1a melanoma is 15 months, while stage M1b is 8 months. The median survival time of bone metastasis melanoma is 6 months, while liver and brain metastasis is 4 months. The overall median survival time of metastatic melanoma is only 7.5 months, and the 2-year survival rate is 15%. For patients with advanced melanoma, dacarbazine is the only chemotherapy drug approved by NMPA, but its overall effective rate is only 13.4%, and the median survival time is 5.6 ~ 11 months. Therapies(new drugs or new combination treatments)with higher remission rate and longer survival are urgently needed for patients with advanced melanoma.

All Clinical Trials for dacarbazine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002791 ↗	Chemotherapy Plus Radiation Therapy Followed by Surgery in Treating Patients With Soft Tissue Sarcoma	Completed	Eastern Cooperative Oncology Group	Phase 2	1997-02-01	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 radiation therapy with more than one chemotherapy drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy followed by surgery in treating patients who have soft tissue sarcoma.
NCT00002669 ↗	Combination Chemotherapy, Interferon Alfa, and Interleukin-2 in Treating Patients With Metastatic Melanoma	Completed	European Organisation for Research and Treatment of Cancer - EORTC	Phase 2	1995-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of the cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. It is not yet known which treatment regimen is more effective in treating melanoma. PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of combination chemotherapy plus interferon alfa and interleukin-2 in treating patients who have metastatic melanoma.
NCT00002561 ↗	Radiation Therapy and Chemotherapy in Treating Patients With Hodgkin's Disease	Completed	Eastern Cooperative Oncology Group	Phase 3	1994-01-25	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 more than one drug or combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy, with or without chemotherapy, with chemotherapy alone in treating patients with stage I or stage IIA Hodgkin's disease.
NCT00002561 ↗	Radiation Therapy and Chemotherapy in Treating Patients With Hodgkin's Disease	Completed	NCIC Clinical Trials Group	Phase 3	1994-01-25	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 more than one drug or combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy, with or without chemotherapy, with chemotherapy alone in treating patients with stage I or stage IIA Hodgkin's disease.
NCT00000626 ↗	Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease	Completed	Amgen	Phase 2	1969-12-31	Primary: To assess the toxicity of chemotherapy with ABVD (doxorubicin / bleomycin / vinblastine / dacarbazine) when given with filgrastim ( granulocyte colony-stimulating factor; G-CSF ) in patients with underlying HIV infection and Hodgkin's disease; to observe the efficacy of ABVD and G-CSF in reducing tumor burden in HIV-infected patients with Hodgkin's disease. Secondary: To determine the durability of tumor response to ABVD plus G-CSF over the 2-year study period; to observe the incidence of bacterial and opportunistic infections in HIV-infected patients with Hodgkin's disease receiving this regimen; to document quality of life of patients receiving this regimen. Addition of granulocyte colony-stimulating factor may prevent neutropenia caused by chemotherapy, allowing more timely administration of chemotherapy and improved response.
NCT00000626 ↗	Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	Primary: To assess the toxicity of chemotherapy with ABVD (doxorubicin / bleomycin / vinblastine / dacarbazine) when given with filgrastim ( granulocyte colony-stimulating factor; G-CSF ) in patients with underlying HIV infection and Hodgkin's disease; to observe the efficacy of ABVD and G-CSF in reducing tumor burden in HIV-infected patients with Hodgkin's disease. Secondary: To determine the durability of tumor response to ABVD plus G-CSF over the 2-year study period; to observe the incidence of bacterial and opportunistic infections in HIV-infected patients with Hodgkin's disease receiving this regimen; to document quality of life of patients receiving this regimen. Addition of granulocyte colony-stimulating factor may prevent neutropenia caused by chemotherapy, allowing more timely administration of chemotherapy and improved response.

Clinical Trial Conditions for dacarbazine

Condition Name

Condition Name for dacarbazine
Intervention	Trials
Melanoma	36
Hodgkin Lymphoma	28
Lymphoma	21
Malignant Melanoma	13

Condition MeSH

Condition MeSH for dacarbazine
Intervention	Trials
Melanoma	106
Hodgkin Disease	85
Lymphoma	79
Sarcoma	17

Clinical Trial Locations for dacarbazine

Trials by Country

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Trials by Country for dacarbazine
Location	Trials
Canada	133
Germany	100
United Kingdom	99
Italy	98
Australia	81

Trials by US State

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−

Trials by US State for dacarbazine
Location	Trials
California	68
New York	56
Texas	56
Illinois	47
Pennsylvania	47

Clinical Trial Progress for dacarbazine

Clinical Trial Phase

Clinical Trial Phase for dacarbazine
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	62
Phase 2/Phase 3	5

Clinical Trial Status

Clinical Trial Status for dacarbazine
Clinical Trial Phase	Trials
Completed	105
Recruiting	44
Active, not recruiting	32

Clinical Trial Sponsors for dacarbazine

Sponsor Name

Sponsor Name for dacarbazine
Sponsor	Trials
National Cancer Institute (NCI)	33
Bristol-Myers Squibb	15
Seagen Inc.	12

Sponsor Type

Sponsor Type for dacarbazine
Sponsor	Trials
Other	242
Industry	154
NIH	35

Clinical Trials, Market Analysis, and Projections for Dacarbazine

Introduction to Dacarbazine

Dacarbazine, also known as DTIC, is a chemotherapy medication used in the treatment of various cancers, including melanoma, Hodgkin's disease, and soft tissue sarcomas. Despite its long-standing use, the drug's efficacy and market position have evolved significantly with the advent of newer, more targeted therapies.

Clinical Trials and Efficacy

Historical Context and Efficacy

Dacarbazine has been a standard treatment for metastatic melanoma, but its efficacy has been questioned in recent years. A Cochrane review highlighted that no Phase III study has demonstrated a survival advantage for dacarbazine over placebo. Additionally, dacarbazine has been shown to be inferior in terms of overall survival compared to BRAF inhibitors (such as vemurafenib and dabrafenib) and MEK inhibitors (like trametinib) in patients with BRAF-mutated melanoma[4].

Comparative Studies

A multicenter Phase III randomized trial compared the Dartmouth regimen (which includes dacarbazine, cisplatin, carmustine, and tamoxifen) with standard dacarbazine treatment in stage IV melanoma patients. The study found no significant difference in survival time between the two treatment arms, although the Dartmouth regimen had a slightly higher tumor response rate[4].

Current and Emerging Alternatives

The initiation of new clinical trials for other drugs has further marginalized dacarbazine's role. For instance, the SEACRAFT-2 pivotal Phase 3 trial is evaluating the combination of naporafenib and trametinib in patients with NRAS-mutant metastatic melanoma, showing more promising results in terms of median overall survival (mOS) and median progression-free survival (mPFS) compared to historical benchmarks for dacarbazine[1].

Market Analysis

Market Size and Growth

The global dacarbazine market is expected to grow, albeit at a modest rate. The market size is projected to increase from its 2022 value to a higher figure by 2029, with a compound annual growth rate (CAGR) that reflects the gradual decline in its usage due to the emergence of more effective treatments[5].

Key Players

The dacarbazine market is dominated by several key players, including Lingnan Pharma, Ruiying Xianfeng Pharma, Sino-Pharma Yixin, Nanjing Pharma, Pude Pharma, TEVA, DBL Pharma, Cytomed, Salius Pharma, and Celon Labs. These companies are involved in the manufacturing and distribution of dacarbazine, catering to various regions and market segments[2].

Market Segmentation

The market is segmented by type, application, and region. The applications covered include hospital pharmacies, retail pharmacies, and online pharmacies. This segmentation helps in understanding the distribution channels and consumer preferences, which are crucial for market strategy and growth[2].

Market Projections

Revenue and Volume Forecast

The global dacarbazine market is forecasted in terms of both revenue and volume. The revenue forecast indicates a gradual increase, reflecting the continued but diminishing use of dacarbazine in certain clinical settings. The volume forecast, measured in kilograms, also shows a steady but slow growth, aligning with the revenue projections[5].

Competitive Landscape

The competitive landscape of the dacarbazine market is characterized by the presence of multiple manufacturers. However, the market is increasingly competitive due to the introduction of newer, more targeted therapies. This competition is expected to impact the market share of dacarbazine, as healthcare providers and patients opt for more effective and safer treatment options[2].

Challenges and Future Outlook

Declining Market Share

Dacarbazine's market share is expected to decline as newer therapies with better efficacy and safety profiles become more widely adopted. For example, the combination of naporafenib and trametinib has shown favorable median overall survival and progression-free survival rates in patients with NRAS-mutant melanoma, making it a more attractive option[1].

Regulatory and Economic Factors

The cost and availability of dacarbazine also play a significant role in its market dynamics. In some regions, such as Australia, dacarbazine is not listed on the Pharmaceutical Benefits Scheme (PBS), which can affect its accessibility and affordability for patients[4].

Key Takeaways

• Efficacy Concerns: Dacarbazine has been shown to be less effective compared to newer targeted therapies in treating certain types of cancer, particularly melanoma.
• Market Growth: The global dacarbazine market is expected to grow at a modest rate, driven by continued use in some clinical settings despite the emergence of better alternatives.
• Competitive Landscape: The market is highly competitive, with multiple manufacturers, but the introduction of newer therapies is expected to erode dacarbazine's market share.
• Regulatory and Economic Factors: The cost and availability of dacarbazine, including its listing on pharmaceutical benefits schemes, influence its market position.

FAQs

What is the current status of dacarbazine in the treatment of melanoma?

Dacarbazine is no longer considered a first-line treatment for melanoma due to its inferior efficacy compared to newer targeted therapies like BRAF and MEK inhibitors.

Which companies are the main players in the dacarbazine market?

The main players include Lingnan Pharma, Ruiying Xianfeng Pharma, Sino-Pharma Yixin, Nanjing Pharma, Pude Pharma, TEVA, DBL Pharma, Cytomed, Salius Pharma, and Celon Labs.

What are the projected growth rates for the global dacarbazine market?

The market is expected to grow at a modest CAGR from 2022 to 2029, reflecting the gradual decline in its usage due to the emergence of more effective treatments.

How does dacarbazine compare to newer therapies in terms of efficacy?

Dacarbazine has been shown to have inferior overall survival and progression-free survival rates compared to newer therapies such as the combination of naporafenib and trametinib in NRAS-mutant melanoma.

What are the key applications of dacarbazine?

Dacarbazine is used in hospital pharmacies, retail pharmacies, and online pharmacies, primarily for the treatment of melanoma, Hodgkin's disease, and soft tissue sarcomas.

Is dacarbazine listed on pharmaceutical benefits schemes?

In some regions, such as Australia, dacarbazine is not listed on the Pharmaceutical Benefits Scheme (PBS), affecting its accessibility and affordability for patients.

Sources

1. Erasca Initiates SEACRAFT-2 Pivotal Phase 3 Trial Evaluating Naporafenib Plus Trametinib in Patients with NRAS-Mutant Melanoma. Erasca.
2. Dacarbazine Market, Report Size, Worth, Revenue, Growth, Industry. Valuates Reports.
3. Phase Ib Study of Unesbulin (PTC596) Plus Dacarbazine for the Treatment of Advanced Leiomyosarcoma. PubMed.
4. Melanoma metastatic dacarbazine SUPERSEDED. eviQ.
5. Global Dacarbazine Market Growth 2023-2029. Market Research Reports.