CLINICAL TRIALS PROFILE FOR VEPESID

505(b)(2) Clinical Trials for Vepesid

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	NCT05019716 ↗	Testing the Safety and Efficacy of the Addition of A New Anti-cancer Drug, ZEN003694, to Chemotherapy Treatment (Etoposide and Cisplatin) for Adult and Pediatric Patients (12-17 Years) With NUT Carcinoma	Not yet recruiting	National Cancer Institute (NCI)	Phase 1/Phase 2	2022-04-29	This phase I/II trial tests the safety, side effects, and best dose of a new combination of drugs, ZEN003694, cisplatin, and etoposide in treating patients with NUT carcinoma (phase I), and identifies whether this combination therapy works to shrink tumor in these patients (phase II). Another purpose of this study is to see whether there are any changes in patient's tumor or blood characteristics (e.g. genes, molecules, etc.) due to combination therapy. ZEN003694 inhibits the production of certain growth-promoting proteins and may prevent proliferation of tumor cells that use those proteins for their growth. Chemotherapy drugs, such as etoposide and cisplatin, work by stopping or slowing the growth of cancer cells. Combination therapy with ZEN003694, etoposide and cisplatin may be effective in treating patients with NUT carcinoma.

All Clinical Trials for Vepesid

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002524 ↗	Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma	Completed	National Cancer Institute (NCI)	Phase 2	1993-06-01	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. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with AIDS-related lymphoma.
NCT00002524 ↗	Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma	Completed	M.D. Anderson Cancer Center	Phase 2	1993-06-01	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. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with AIDS-related lymphoma.
NCT00002610 ↗	Chemotherapy With or Without Surgery, Radiation Therapy, or Stem Cell Transplantation in Treating Young Patients With Kidney Tumors	Completed	National Cancer Institute (NCI)	Phase 3	1996-01-01	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 chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known which therapy regimen is most effective for treating patients with kidney tumors. PURPOSE: Phase III trial to compare the effectiveness of chemotherapy with or without radiation therapy, surgery, and/or peripheral stem cell or bone marrow transplantation in treating young patients with kidney tumors.
NCT00002610 ↗	Chemotherapy With or Without Surgery, Radiation Therapy, or Stem Cell Transplantation in Treating Young Patients With Kidney Tumors	Completed	Children's Oncology Group	Phase 3	1996-01-01	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 chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known which therapy regimen is most effective for treating patients with kidney tumors. PURPOSE: Phase III trial to compare the effectiveness of chemotherapy with or without radiation therapy, surgery, and/or peripheral stem cell or bone marrow transplantation in treating young patients with kidney tumors.
NCT00002805 ↗	Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome	Completed	National Cancer Institute (NCI)	Phase 2	1997-08-01	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. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with acute myeloid leukemia or myelodysplastic syndrome in first relapse or who did not achieve first remission.
NCT00002805 ↗	Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome	Completed	Children's Oncology Group	Phase 2	1997-08-01	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. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with acute myeloid leukemia or myelodysplastic syndrome in first relapse or who did not achieve first remission.
NCT00002816 ↗	Combination Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia	Completed	National Cancer Institute (NCI)	Phase 3	1996-12-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase III trial to compare the effectiveness of combination chemotherapy in treating children who have relapsed acute lymphoblastic leukemia.

Clinical Trial Conditions for Vepesid

Condition Name

Condition Name for Vepesid
Intervention	Trials
Lymphoma	27
Leukemia	12
Recurrent Diffuse Large B-Cell Lymphoma	12
Refractory Diffuse Large B-Cell Lymphoma	10

Condition MeSH

Condition MeSH for Vepesid
Intervention	Trials
Lymphoma	89
Leukemia	48
Lymphoma, B-Cell	37
Lymphoma, Non-Hodgkin	36

Clinical Trial Locations for Vepesid

Trials by Country

Trials by Country for Vepesid
Location	Trials
Canada	353
New Zealand	44
Puerto Rico	37
Saudi Arabia	7
Poland	7

Trials by US State

Trials by US State for Vepesid
Location	Trials
Texas	111
California	106
New York	98
Washington	89
Missouri	87

Clinical Trial Progress for Vepesid

Clinical Trial Phase

Clinical Trial Phase for Vepesid
Clinical Trial Phase	Trials
Phase 3	50
Phase 2/Phase 3	5
Phase 2	98

Clinical Trial Status

Clinical Trial Status for Vepesid
Clinical Trial Phase	Trials
Completed	93
Recruiting	50
Active, not recruiting	40

Clinical Trial Sponsors for Vepesid

Sponsor Name

Sponsor Name for Vepesid
Sponsor	Trials
National Cancer Institute (NCI)	159
Children's Oncology Group	48
M.D. Anderson Cancer Center	34

Sponsor Type

Sponsor Type for Vepesid
Sponsor	Trials
Other	218
NIH	163
Industry	49

VEPESID (Etoposide): Clinical Trials, Market Analysis, and Projections

Introduction to VEPESID (Etoposide)

VEPESID, commonly known by its generic name etoposide, is a chemotherapeutic agent used in the treatment of various types of cancer, including small cell lung cancer, testicular cancer, and certain types of leukemia and lymphoma. Here, we will delve into recent clinical trials, market analysis, and future projections for etoposide.

Clinical Trials Update

The OLIE Trial: Lenvatinib Plus Ifosfamide and Etoposide

One of the significant clinical trials involving etoposide is the OLIE phase II trial. This open-label, randomized clinical trial evaluated the efficacy and safety of combining lenvatinib with ifosfamide and etoposide (LEN-IE) in children and young adults with relapsed or refractory osteosarcoma.

• Participants and Design: The trial was conducted globally across Europe, Asia and the Pacific, and North America, enrolling patients aged 2 to 25 years with high-grade osteosarcoma and 1 to 2 prior lines of systemic treatment[1][4].
• Interventions: Patients were randomized to receive either LEN-IE or ifosfamide and etoposide (IE) alone. The LEN-IE arm included lenvatinib (14 mg/m² orally once daily) combined with up to 5 cycles of ifosfamide and etoposide. Patients in the IE arm could cross over to receive lenvatinib upon disease progression[1][4].
• Outcomes: The primary endpoint was progression-free survival (PFS) per RECIST 1.1. The results showed a median PFS of 6.5 months in the LEN-IE arm and 5.5 months in the IE arm, although the difference did not reach the prespecified statistical significance threshold[4].

Implications for Etoposide

The OLIE trial highlights the ongoing research into optimizing etoposide-based regimens. While the trial did not meet its primary statistical significance threshold, it suggests that combining etoposide with other agents like lenvatinib may offer some benefits in certain patient populations.

Market Analysis

Current Market Size and Growth

The global etoposide market was valued at US$ 715.62 million in 2023 and is projected to grow at a CAGR of 5.8% from 2024 to 2030, reaching nearly US$ 1061.89 million by 2030[2].

Market Drivers

• Increasing Prevalence of Cancer: The growing prevalence of cancers such as prostate cancer, small cell lung cancer, and testicular cancer is a primary driver of the etoposide market. Prostate cancer, in particular, is the second most prevalent cancer among men, with 1.4 million cases globally in 2021[2].
• Aging Population: The world's aging population is another significant factor, as prostate cancer is more frequent among senior citizens[2].
• Research and Development: Continuous research and development in cancer treatments, including the exploration of etoposide in combination therapies for various cancers, are expected to drive market growth[2].

Regional Insights

• North America: This region is expected to hold a considerable market share due to the rising frequency of prostate cancer, increasing awareness, and significant investment in research and development. The US and Canada are key markets in this region[2].
• Asia Pacific: The market in the Asia Pacific region is also expected to grow, driven by the increasing prevalence of infectious and chronic diseases, which will propel the demand for new cancer treatments[3].

Market Projections

Forecast Period

The etoposide market is anticipated to experience steady growth over the next decade. Here are some key projections:

• Market Size: The market is expected to reach nearly US$ 1061.89 million by 2030, growing at a CAGR of 5.8% from 2024 to 2030[2].
• Application Segments: The small cell lung cancer segment is expected to grow at a CAGR of 3.8% during the forecast period. Etoposide's importance in treating germ cell tumors and small-cell lung disease is likely to remain significant[2].

Potential New Uses

Ongoing clinical research may lead to the development of active etoposide-containing combination therapies for cervical cancer, breast cancer, and several pediatric cancers. The use of etoposide in conjunction with topoisomerase I blockers and the discovery of medications to reverse treatment resistance are also potential areas of growth[2].

Challenges and Opportunities

Challenges

• High Cost of Cancer Medications: One of the major restraints for the etoposide market is the high cost of cancer medications, particularly those used in lung cancer treatments[2].
• Treatment Resistance: Overcoming treatment resistance remains a significant challenge in cancer therapy, and ongoing research aims to address this issue[2].

Opportunities

• Combination Therapies: The potential for etoposide in combination therapies offers significant opportunities for market growth. Research into pairing etoposide with other agents, such as lenvatinib, could lead to improved outcomes for various cancers[1][4].
• Emerging Markets: The Asia Pacific region, with its increasing prevalence of chronic diseases, presents a substantial opportunity for the etoposide market[3].

Key Takeaways

• Clinical Trials: The OLIE trial and other ongoing studies are exploring the efficacy of etoposide in combination with other agents.
• Market Growth: The etoposide market is projected to grow at a CAGR of 5.8% from 2024 to 2030, driven by the increasing prevalence of cancers and ongoing research.
• Regional Insights: North America and the Asia Pacific region are expected to be significant markets for etoposide.
• Potential New Uses: Ongoing research may expand etoposide's use in various cancer treatments.

FAQs

What is the current market size of the etoposide market?

The global etoposide market was valued at US$ 715.62 million in 2023[2].

What is the projected growth rate of the etoposide market?

The etoposide market is expected to grow at a CAGR of 5.8% from 2024 to 2030[2].

Which region is expected to hold a significant market share for etoposide?

North America, particularly the US and Canada, is expected to hold a considerable market share due to the rising frequency of prostate cancer and significant investment in research and development[2].

What are the primary drivers of the etoposide market?

The primary drivers include the growing prevalence of cancers such as prostate cancer, the aging population, and ongoing research and development in cancer treatments[2].

What are some potential new uses for etoposide?

Ongoing clinical research may lead to the development of active etoposide-containing combination therapies for cervical cancer, breast cancer, and several pediatric cancers, as well as its use in conjunction with topoisomerase I blockers[2].

Sources

1. PubMed: Lenvatinib Plus Ifosfamide and Etoposide in Children and Young Adults with Relapsed or Refractory Osteosarcoma.
2. Maximize Market Research: Etoposide Market - Region and Forecast (2024-2030).
3. Fortune Business Insights: Clinical Trials Market SIZE, SHARE | GROWTH REPORT [2032].
4. JAMA Oncology: Lenvatinib Plus Ifosfamide and Etoposide in Children and Young Adults with Relapsed or Refractory Osteosarcoma.
5. Research Nester: Germ Cell Tumor Market Size - Growth Forecasts 2037.