CLINICAL TRIALS PROFILE FOR VINCASAR PFS

505(b)(2) Clinical Trials for VINCASAR PFS

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
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.
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	Northwestern University	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.

All Clinical Trials for VINCASAR PFS

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00075725 ↗	Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia	Completed	National Cancer Institute (NCI)	Phase 3	2003-12-29	This randomized phase III trial is studying dexamethasone to see how well it works compared to prednisone during induction therapy. This trial is also studying methotrexate and leucovorin calcium to see how well they work compared to methotrexate alone during maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia (ALL). Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium, work in different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.
NCT00075725 ↗	Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia	Completed	Children's Oncology Group	Phase 3	2003-12-29	This randomized phase III trial is studying dexamethasone to see how well it works compared to prednisone during induction therapy. This trial is also studying methotrexate and leucovorin calcium to see how well they work compared to methotrexate alone during maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia (ALL). Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium, work in different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.
NCT00026208 ↗	Combination Chemotherapy Plus Low-Dose Radiation Therapy in Treating Patients With Stage I or Stage IIA Hodgkin's Lymphoma	Completed	Stanford University	Phase 2	2001-06-01	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 tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: This phase 2 trial is studying how well giving combination chemotherapy together with low-dose radiation therapy works in treating patients with stage I or stage IIA Hodgkin's lymphoma.
NCT00004010 ↗	Combination Chemotherapy and Radiation Therapy in Treating Children With Previously Untreated Stage II, Stage III, or Stage IV Hodgkin's Disease	Completed	National Cancer Institute (NCI)	Phase 2	1999-10-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. Giving radiation therapy after chemotherapy may be an effective treatment for Hodgkin's disease. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating children who have previously untreated stage II, stage III, or stage IV Hodgkin's disease.
NCT00004010 ↗	Combination Chemotherapy and Radiation Therapy in Treating Children With Previously Untreated Stage II, Stage III, or Stage IV Hodgkin's Disease	Completed	Children's Oncology Group	Phase 2	1999-10-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. Giving radiation therapy after chemotherapy may be an effective treatment for Hodgkin's disease. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating children who have previously untreated stage II, stage III, or stage IV Hodgkin's disease.

Clinical Trial Conditions for VINCASAR PFS

Condition Name

Condition Name for VINCASAR PFS
Intervention	Trials
Acute Lymphoblastic Leukemia	20
Untreated Adult Acute Lymphoblastic Leukemia	13
B Acute Lymphoblastic Leukemia	11
Untreated Childhood Acute Lymphoblastic Leukemia	11

Condition MeSH

Condition MeSH for VINCASAR PFS
Intervention	Trials
Lymphoma	43
Leukemia	42
Precursor Cell Lymphoblastic Leukemia-Lymphoma	40
Leukemia, Lymphoid	39

Clinical Trial Locations for VINCASAR PFS

Trials by Country

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Trials by Country for VINCASAR PFS
Location	Trials
Canada	231
Australia	95
New Zealand	35
Puerto Rico	25
Switzerland	8

Trials by US State

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−

Trials by US State for VINCASAR PFS
Location	Trials
Texas	62
Ohio	58
California	58
New York	56
Illinois	56

Clinical Trial Progress for VINCASAR PFS

Clinical Trial Phase

Clinical Trial Phase for VINCASAR PFS
Clinical Trial Phase	Trials
Phase 3	31
Phase 2/Phase 3	4
Phase 2	34

Clinical Trial Status

Clinical Trial Status for VINCASAR PFS
Clinical Trial Phase	Trials
Active, not recruiting	36
Recruiting	29
Completed	15

Clinical Trial Sponsors for VINCASAR PFS

Sponsor Name

Sponsor Name for VINCASAR PFS
Sponsor	Trials
National Cancer Institute (NCI)	85
Children's Oncology Group	25
M.D. Anderson Cancer Center	13

Sponsor Type

Sponsor Type for VINCASAR PFS
Sponsor	Trials
NIH	85
Other	75
Industry	22

VINCASAR PFS: Clinical Trials, Market Analysis, and Projections

Introduction to VINCASAR PFS

VINCASAR PFS, also known as vincristine sulfate injection, is a chemotherapeutic agent derived from the periwinkle plant (Vinca rosea Linn). It is used in the treatment of various cancers, including acute leukemia, Hodgkin's disease, non-Hodgkin's malignant lymphomas, rhabdomyosarcoma, neuroblastoma, and Wilms' tumor[2][4].

Mechanism of Action

The mechanism of action of vincristine sulfate involves the inhibition of microtubule formation in the mitotic spindle, leading to an arrest of dividing cells at the metaphase stage. This action is crucial in halting the proliferation of cancer cells[2].

Clinical Uses

VINCASAR PFS is FDA-approved for the treatment of acute leukemia and is often used in combination with other oncolytic agents for various other cancers. Its unique toxicity profile, particularly the lack of significant bone-marrow suppression at recommended doses, makes it a valuable component in polychemotherapy regimens[2][4].

Dosage and Administration

The dosage of VINCASAR PFS is carefully calculated due to its potential for neurotoxicity and other severe side effects. For pediatric patients, the usual dose is 1.5 to 2 mg/m², while for adults, it is 1.4 mg/m². The drug is administered intravenously at weekly intervals, and extreme care is necessary to avoid overdosage, which can be fatal[1][2].

Side Effects and Interactions

VINCASAR PFS is associated with several side effects, including neurotoxicity, paralytic ileus, genitourinary issues, cardiovascular effects, and hematologic changes such as anemia, leukopenia, and thrombocytopenia. It also interacts with other drugs, such as phenytoin and itraconazole, which can affect its metabolism and efficacy[1][2].

Current Clinical Trials Landscape

Overview of Clinical Trials

Clinical trials play a critical role in the development and approval of drugs like VINCASAR PFS. These trials are rigorously regulated by the FDA to ensure patient safety and data integrity. The U.S. clinical trials market, which includes trials for oncology drugs, is expected to grow significantly, driven by ongoing research efforts and the need for innovative healthcare solutions[3].

Phase I Trials

Phase I trials, which are the initial human testing phase for new drugs, are crucial for assessing the safety and pharmacokinetics of drugs like VINCASAR PFS. These trials are expected to exhibit the most rapid growth during the forecast period, reflecting their importance in transitioning from laboratory and animal testing to human subjects[3].

Oncology Segment

The oncology segment, which includes drugs like VINCASAR PFS, accounted for the maximum revenue share in the U.S. clinical trials market in 2023 and is anticipated to register the fastest CAGR over the forecast period. This growth is driven by the continuous need for effective cancer treatments and the significant investments in cancer research[3].

Market Analysis and Projections

Market Size and Growth

The U.S. clinical trials market, which encompasses trials for drugs like VINCASAR PFS, was valued at USD 25.81 billion in 2023 and is expected to grow to USD 41.57 billion by 2033. The oncology segment, in particular, is projected to continue its dominance and rapid growth[3].

Regional Dominance

North America, with its strong presence of leading pharmaceutical companies and advanced healthcare infrastructure, is expected to dominate the market for nephroblastoma treatment, which includes drugs like VINCASAR PFS. The Asia Pacific region is anticipated to be the fastest-growing region due to increasing investments in healthcare and research[5].

Distribution Channels

Hospital pharmacies are expected to contribute the highest market share for oncology drugs, including VINCASAR PFS, due to the complex treatment needs of patients that require specialized supervision and critical infrastructure[5].

Key Takeaways

• Clinical Trials Growth: The U.S. clinical trials market, particularly the oncology segment, is poised for significant growth driven by ongoing research and the need for innovative treatments.
• Oncology Dominance: The oncology segment, which includes drugs like VINCASAR PFS, will continue to dominate the market with the fastest CAGR.
• Regional Trends: North America will remain a dominant region, while the Asia Pacific region will experience the fastest growth.
• Distribution Channels: Hospital pharmacies will continue to play a crucial role in the distribution of oncology drugs.
• Safety and Efficacy: Clinical trials will remain critical for ensuring the safety and efficacy of drugs like VINCASAR PFS.

FAQs

What is VINCASAR PFS used for?

VINCASAR PFS is used in the treatment of acute leukemia and in combination with other agents for the treatment of Hodgkin's disease, non-Hodgkin's malignant lymphomas, rhabdomyosarcoma, neuroblastoma, and Wilms' tumor[2][4].

How is VINCASAR PFS administered?

VINCASAR PFS is administered intravenously at weekly intervals. The dosage is carefully calculated to avoid neurotoxicity and other severe side effects[1][2].

What are the common side effects of VINCASAR PFS?

Common side effects include neurotoxicity, paralytic ileus, genitourinary issues, cardiovascular effects, and hematologic changes such as anemia, leukopenia, and thrombocytopenia[1][2].

How does VINCASAR PFS interact with other drugs?

VINCASAR PFS interacts with drugs like phenytoin and itraconazole, which can affect its metabolism and efficacy. Caution is advised when using these drugs concurrently[1][2].

What is the projected growth of the U.S. clinical trials market?

The U.S. clinical trials market is expected to grow from USD 27.07 billion in 2024 to USD 41.57 billion by 2033, with the oncology segment experiencing the fastest CAGR[3].

Sources

1. RxList: Vincasar PFS (Vincristine Sulfate Injection) - RxList
2. Drugs.com: Vincasar PFS: Package Insert / Prescribing Information - Drugs.com
3. Biospace: U.S. Clinical Trials Market Size Industry Analysis Report, 2033
4. Tahoe Forest Health System: Vincasar® PFS | Tahoe Forest Health System
5. Coherent Market Insights: Nephroblastoma Treatment Market - Trends, Size, Share & Forecast