CLINICAL TRIALS PROFILE FOR VINCRISTINE SULFATE PFS

505(b)(2) Clinical Trials for Vincristine Sulfate 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 Vincristine Sulfate Pfs

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000658 ↗	A Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkin's Lymphoma	Completed	Schering-Plough	Phase 3	1969-12-31	To determine the impact of dose intensity on tumor response and survival in patients with HIV-associated non-Hodgkin's lymphoma (NHL). HIV-infected patients are at increased risk for developing intermediate and high-grade NHL. While combination chemotherapy for aggressive B-cell NHL in the absence of immunodeficiency is highly effective, the outcome of therapy for patients with AIDS-associated NHL has been disappointing. Treatment is frequently complicated by the occurrence of multiple opportunistic infections, as well as the presence of poor bone marrow reserve, making the administration of standard doses of chemotherapy difficult. A recent study was completed using a low-dose modification of the standard mBACOD (cyclophosphamide, doxorubicin, vincristine, bleomycin, dexamethasone, methotrexate ) treatment. A 46 percent response rate was observed in patients treated with this combination of chemotherapeutic agents, with a number of durable remissions and reduced toxicity when compared to previous experience with more standard treatments. A subsequent study showed similar effectiveness using a lower dose of methotrexate administered on day 15. It is hoped that the use of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) will improve bone marrow function and allow for administration of a higher dose of chemotherapy.
NCT00000658 ↗	A Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkin's Lymphoma	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	To determine the impact of dose intensity on tumor response and survival in patients with HIV-associated non-Hodgkin's lymphoma (NHL). HIV-infected patients are at increased risk for developing intermediate and high-grade NHL. While combination chemotherapy for aggressive B-cell NHL in the absence of immunodeficiency is highly effective, the outcome of therapy for patients with AIDS-associated NHL has been disappointing. Treatment is frequently complicated by the occurrence of multiple opportunistic infections, as well as the presence of poor bone marrow reserve, making the administration of standard doses of chemotherapy difficult. A recent study was completed using a low-dose modification of the standard mBACOD (cyclophosphamide, doxorubicin, vincristine, bleomycin, dexamethasone, methotrexate ) treatment. A 46 percent response rate was observed in patients treated with this combination of chemotherapeutic agents, with a number of durable remissions and reduced toxicity when compared to previous experience with more standard treatments. A subsequent study showed similar effectiveness using a lower dose of methotrexate administered on day 15. It is hoped that the use of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) will improve bone marrow function and allow for administration of a higher dose of chemotherapy.
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.
NCT00000689 ↗	Phase I Trial of mBACOD and Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in AIDS-Associated Large Cell, Immunoblastic, and Small Non-cleaved Lymphoma	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To determine the toxicity and effectiveness of adding sargramostim (recombinant granulocyte-macrophage colony stimulating factor; GM-CSF) to a standard chemotherapy drug combination (methotrexate, bleomycin, doxorubicin, cyclophosphamide, vincristine, and dexamethasone) known as mBACOD in the treatment of non-Hodgkin's lymphoma in patients who are infected with HIV. Treatment of patients with AIDS-associated lymphoma is achieving inferior results when compared with outcomes for non-AIDS patients. Treatment with mBACOD has been promising, but the toxicity is very high. Patients treated with mBACOD have very low white blood cell counts. GM-CSF has increased the number of white blood cells in animal studies and preliminary human studies. It is hoped that including GM-CSF among the drugs given to lymphoma patients will prevent or lessen the decrease in white blood cells caused by mBACOD.

Clinical Trial Conditions for Vincristine Sulfate Pfs

Condition Name

Condition Name for Vincristine Sulfate Pfs
Intervention	Trials
Lymphoma	139
Leukemia	72
Neuroblastoma	33
Acute Lymphoblastic Leukemia	27

Condition MeSH

Condition MeSH for Vincristine Sulfate Pfs
Intervention	Trials
Lymphoma	216
Leukemia	137
Leukemia, Lymphoid	124
Precursor Cell Lymphoblastic Leukemia-Lymphoma	123

Clinical Trial Locations for Vincristine Sulfate Pfs

Trials by Country

Trials by Country for Vincristine Sulfate Pfs
Location	Trials
Canada	599
Switzerland	62
Puerto Rico	61
New Zealand	60
Norway	9

Trials by US State

Trials by US State for Vincristine Sulfate Pfs
Location	Trials
California	205
New York	199
Texas	177
Illinois	175
Ohio	172

Clinical Trial Progress for Vincristine Sulfate Pfs

Clinical Trial Phase

Clinical Trial Phase for Vincristine Sulfate Pfs
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	162
Phase 2/Phase 3	9

Clinical Trial Status

Clinical Trial Status for Vincristine Sulfate Pfs
Clinical Trial Phase	Trials
Completed	258
Active, not recruiting	68
Unknown status	66

Clinical Trial Sponsors for Vincristine Sulfate Pfs

Sponsor Name

Sponsor Name for Vincristine Sulfate Pfs
Sponsor	Trials
National Cancer Institute (NCI)	286
Children's Oncology Group	95
Children's Cancer and Leukaemia Group	24

Sponsor Type

Sponsor Type for Vincristine Sulfate Pfs
Sponsor	Trials
Other	557
NIH	297
Industry	83

Vincristine Sulfate PFS: Clinical Trials, Market Analysis, and Projections

Introduction to Vincristine Sulfate PFS

Vincristine sulfate PFS is a chemotherapeutic agent derived from the periwinkle plant (Vinca rosea Linn). It is classified as an antimicrotubule agent, which works by inhibiting the formation of microtubules, thereby disrupting cell division and leading to cell death, particularly in rapidly dividing cancer cells[1][5].

Clinical Trials and Current Research

Ongoing and Recent Trials

Vincristine sulfate is a component in several ongoing clinical trials, particularly in the treatment of various types of cancer and related conditions.

• Neurofibromatosis Type 1 (NF1) Associated Low-Grade Glioma (LGG): A Phase 3 randomized study compares the efficacy of selumetinib versus the standard treatment of carboplatin/vincristine in patients with NF1-associated LGG. This trial aims to determine if selumetinib is as effective as or better than the standard carboplatin/vincristine regimen in improving vision in patients with LGG of the optic pathway[3].

• General Cancer Research: The National Cancer Institute (NCI) supports various clinical trials that include vincristine sulfate as part of the treatment regimen for different types of cancers. These trials are designed to test new and more effective ways to treat cancer using vincristine sulfate in combination with other chemotherapeutic agents[4].

Trial Outcomes and Implications

The outcomes of these trials are crucial for understanding the efficacy and safety of vincristine sulfate in different clinical settings. For instance, the trial comparing selumetinib with carboplatin/vincristine will provide valuable insights into whether selumetinib offers a better therapeutic option for patients with NF1-associated LGG, potentially reducing the side effects associated with traditional chemotherapy.

Market Analysis

Market Size and Growth

The global vincristine sulfate market has been growing steadily. In 2018, the market was valued at a significant amount, and it is projected to continue growing at a compound annual growth rate (CAGR) until 2024. This growth is driven by increasing demand for effective chemotherapeutic agents and advancements in cancer treatment protocols[2].

Key Players and Market Segmentation

The market is dominated by several key players, including Fine Chemicals Corporation, Cipla, and MINAKEM High Potent. The market is segmented by product types (≥99.0% and <99.0% purity), applications (primarily antineoplastic), and regions (North America, Europe, Asia Pacific, Middle East & Africa, and Latin America)[2].

Regional Market Analysis

• North America: This region is a significant market for vincristine sulfate, driven by advanced healthcare infrastructure and high demand for cancer treatments.
• Europe: Countries such as Germany, France, UK, Italy, Russia, and Spain contribute substantially to the European market.
• Asia Pacific: This region, including countries like China, Japan, Korea, and India, is experiencing rapid growth due to increasing healthcare spending and a large patient population.
• Other Regions: The Middle East & Africa and Latin America also represent growing markets, though at a slower pace compared to the other regions[2].

Projections and Future Outlook

Market Forecast

The global vincristine sulfate market is expected to reach a projected value by 2024, driven by the increasing incidence of cancer and the need for effective treatment options. The forecast includes sales and revenue projections by types, applications, and regions, providing a comprehensive outlook on the market's future[2].

Emerging Trends and Opportunities

• Combination Therapies: The use of vincristine sulfate in combination with other chemotherapeutic agents and targeted therapies is expected to continue, offering better treatment outcomes and reducing side effects.
• Generic Versions: The availability of generic versions of vincristine sulfate, following the discontinuation of the brand name Vincasar PFS, is likely to increase accessibility and affordability, further driving market growth[1][5].

Dosage and Administration

Adult and Pediatric Dosage

Vincristine sulfate is administered intravenously, with the usual dose for adults being 1.4 mg/m² once weekly. For children, the dose varies based on weight: initially 0.05 mg/kg for those ≤10 kg and 2 mg/m² for those >10 kg. Dose adjustments are recommended based on serum bilirubin levels and other clinical factors[1].

Adverse Reactions and Interactions

Common Adverse Reactions

Vincristine sulfate is associated with several adverse reactions, including GI upset, paralytic ileus, urinary retention, neuromuscular effects, and hypersensitivity reactions. These side effects necessitate careful patient monitoring and dose adjustments as needed[1].

Drug Interactions

Concomitant use with certain drugs, such as CYP3A4 enzyme inhibitors (e.g., itraconazole) and other neurotoxic or platinum-containing agents, requires caution. Additionally, vincristine sulfate can antagonize phenytoin and should be administered separately from L-asparaginase[1].

Key Takeaways

• Clinical Trials: Ongoing trials are evaluating the efficacy of vincristine sulfate in combination with other agents and comparing it with newer treatments.
• Market Growth: The global market for vincristine sulfate is projected to grow significantly until 2024, driven by increasing demand and advancements in cancer treatment.
• Dosage and Administration: Careful dosing and monitoring are essential due to the potential for adverse reactions and drug interactions.
• Future Outlook: The market is expected to benefit from the availability of generic versions and the continued use in combination therapies.

FAQs

What is the primary use of vincristine sulfate PFS?

Vincristine sulfate PFS is primarily used in combination with other chemotherapeutic agents for the treatment of various cancers, including acute leukemia, Hodgkin's disease, non-Hodgkin's lymphomas, rhabdomyosarcoma, neuroblastoma, and Wilms' tumor[1][5].

What are the common adverse reactions associated with vincristine sulfate PFS?

Common adverse reactions include GI upset, paralytic ileus, urinary retention, neuromuscular effects, and hypersensitivity reactions[1].

How is vincristine sulfate PFS administered?

Vincristine sulfate PFS is administered intravenously, with specific dosages for adults and children based on body surface area or weight[1].

What are the key players in the global vincristine sulfate market?

Key players include Fine Chemicals Corporation, Cipla, and MINAKEM High Potent[2].

What is the projected growth of the global vincristine sulfate market?

The market is projected to grow at a significant CAGR until 2024, driven by increasing demand for effective cancer treatments and advancements in healthcare[2].

Are there any ongoing clinical trials involving vincristine sulfate PFS?

Yes, there are ongoing clinical trials, such as the Phase 3 trial comparing selumetinib with carboplatin/vincristine in patients with NF1-associated LGG[3].