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Last Updated: January 21, 2025

CLINICAL TRIALS PROFILE FOR HYCAMTIN


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All Clinical Trials for Hycamtin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00002913 ↗ Paclitaxel, Cisplatin, and Topotecan With or Without Filgrastim in Treating Patients With Newly Diagnosed Stage III or Stage IV Epithelial Ovarian Cancer Completed National Cancer Institute (NCI) Phase 1 1996-12-01 Phase I trial to study the effectiveness of paclitaxel, cisplatin, and topotecan with or without filgrastim in treating patients who have newly diagnosed stage III or stage IV epithelial ovarian cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy
NCT00003415 ↗ Amifostine Plus Topotecan in Treating Patients With Myelodysplastic Syndrome Completed University of Arizona Phase 1/Phase 2 1998-09-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy. PURPOSE: Phase I/II trial to study the effectiveness of amifostine plus topotecan in treating patients with myelodysplastic syndrome.
NCT00003733 ↗ Sequential Chemotherapy in Treating Patients With Residual Disease Following Surgery for Stage IIB, Stage III, or Stage IV Ovarian Cancer Unknown status SmithKline Beecham Phase 2 1997-12-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs in different ways may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of sequential chemotherapy in treating patients with residual disease following surgery for stage IIB, stage III, or stage IV ovarian cancer.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Hycamtin

Condition Name

Condition Name for Hycamtin
Intervention Trials
Ovarian Cancer 13
Neuroblastoma 11
Solid Tumors 6
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Condition MeSH

Condition MeSH for Hycamtin
Intervention Trials
Small Cell Lung Carcinoma 29
Ovarian Neoplasms 28
Lung Neoplasms 27
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Clinical Trial Locations for Hycamtin

Trials by Country

Trials by Country for Hycamtin
Location Trials
United States 950
Canada 78
Australia 24
Germany 16
United Kingdom 13
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Trials by US State

Trials by US State for Hycamtin
Location Trials
California 42
Texas 35
Ohio 35
Florida 32
New York 32
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Clinical Trial Progress for Hycamtin

Clinical Trial Phase

Clinical Trial Phase for Hycamtin
Clinical Trial Phase Trials
Phase 4 1
Phase 3 19
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Hycamtin
Clinical Trial Phase Trials
Completed 60
Active, not recruiting 14
Recruiting 14
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Clinical Trial Sponsors for Hycamtin

Sponsor Name

Sponsor Name for Hycamtin
Sponsor Trials
National Cancer Institute (NCI) 48
GlaxoSmithKline 21
Children's Oncology Group 11
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Sponsor Type

Sponsor Type for Hycamtin
Sponsor Trials
Other 98
Industry 55
NIH 49
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Hycamtin (Topotecan): Clinical Trials, Market Analysis, and Projections

Introduction

Hycamtin, also known as topotecan, is a chemotherapeutic agent used in the treatment of various types of cancer, including ovarian cancer, small cell lung cancer (SCLC), and cervical cancer. This article provides an update on the clinical trials, market analysis, and projections for Hycamtin.

Clinical Trials Overview

Ovarian Cancer

Hycamtin has been extensively studied in patients with ovarian cancer who have failed previous treatments with platinum-containing chemotherapy. In a significant study involving 226 women, Hycamtin was compared to paclitaxel, another cancer medication. The results showed that 21% of patients receiving Hycamtin responded to the treatment, compared to 14% of those receiving paclitaxel[1].

Small Cell Lung Cancer (SCLC)

In the context of SCLC, Hycamtin has demonstrated promising results. A pivotal Phase III trial compared Hycamtin capsules plus best supportive care (BSC) to BSC alone in patients with relapsed SCLC. This study revealed that patients receiving Hycamtin capsules had a statistically significant improvement in overall survival, with a median survival of 25.9 weeks compared to 13.9 weeks for those receiving BSC alone[3].

Cervical Cancer

For advanced cervical cancer, Hycamtin was studied in combination with cisplatin. The results indicated that patients receiving the combination of Hycamtin and cisplatin had an average survival of 9.4 months, compared to 6.5 months for those receiving cisplatin alone[1].

Efficacy and Safety

Response Rates and Survival

In clinical trials, Hycamtin has shown significant efficacy in various cancer types. For SCLC, the response rate was 20% across all studies, and Hycamtin prolonged survival by 12 weeks compared to symptom control alone. It was also found to be as effective as standard combination chemotherapy[1].

Adverse Reactions

The safety profile of Hycamtin includes common adverse reactions such as hematologic effects (neutropenia, anemia) and non-hematologic effects. In a study involving 226 patients with metastatic ovarian cancer, Grade 3 and 4 hematologic and non-hematologic adverse reactions were observed, highlighting the need for careful monitoring and management of side effects[4].

Market Analysis

Global Market Size and Growth

The global Topotecan Hydrochloride market, which includes Hycamtin, is projected to grow significantly. By 2024, the market size is estimated to be USD 572.6 million, with a compound annual growth rate (CAGR) of 5.00% from 2024 to 2031, reaching USD 805.70 million by 2031[5].

Regional Market Trends

  • North America: Held more than 40% of the global revenue in 2024, with a market size of USD 229.04 million, and is expected to grow at a CAGR of 3.2% from 2024 to 2031[5].
  • Europe: Accounted for more than 30% of the global revenue in 2024, with a market size of USD 171.78 million, and is expected to grow at a CAGR of 3.5% from 2024 to 2031[5].
  • Asia-Pacific: Projected to expand at the fastest CAGR, driven by increasing cancer prevalence, improving healthcare infrastructure, and rising investment in medical research. This region held around 23% of the global revenue in 2024[5].

Market Segments

  • Hospitals: The largest segment due to their comprehensive infrastructure and capacity to manage complex cancer treatments. Hospitals handle a higher volume of patients requiring intravenous medications like Hycamtin[5].
  • Specialty Clinics: The fastest-growing segment, driven by their focused expertise in oncology and personalized treatment approaches. These clinics offer advanced therapies, including targeted cancer treatments like Hycamtin[5].

Projections and Future Outlook

Sales Forecast

By 2025, the global Topotecan Hydrochloride market is expected to continue its growth trajectory, driven by the increasing prevalence of cancer and advancements in healthcare infrastructure. The Asia-Pacific region is anticipated to be a key driver of this growth due to its rapid expansion in healthcare facilities and medical research investments[5].

Competitive Landscape

The market for topotecan hydrochloride is influenced by the introduction of biosimilars, which can impact the sales of branded products. However, the unique positioning of Hycamtin as an oral single-agent chemotherapy for SCLC and its efficacy in other cancer types are expected to maintain its market presence[2][5].

Emerging Trends

The trend towards personalized medicine and the use of lower doses to minimize side effects are expected to continue. This could lead to further growth in the segment of patients receiving tailored treatments, enhancing the market for Hycamtin[5].

Key Takeaways

  • Clinical Efficacy: Hycamtin has demonstrated significant efficacy in treating ovarian cancer, SCLC, and cervical cancer, with improved response rates and survival outcomes.
  • Market Growth: The global Topotecan Hydrochloride market is projected to grow at a CAGR of 5.00% from 2024 to 2031, driven by increasing cancer prevalence and healthcare advancements.
  • Regional Trends: Asia-Pacific is expected to be a key growth region, while North America and Europe will continue to be significant markets.
  • Market Segments: Hospitals remain the largest segment, but specialty clinics are the fastest-growing due to their focus on personalized and advanced cancer treatments.

FAQs

What is Hycamtin used for?

Hycamtin (topotecan) is used in the treatment of ovarian cancer, small cell lung cancer (SCLC), and cervical cancer, particularly in patients who have failed previous treatments.

What are the key findings from clinical trials of Hycamtin?

Clinical trials have shown that Hycamtin improves response rates and survival in patients with ovarian cancer, SCLC, and cervical cancer. For SCLC, it has been shown to prolong survival compared to symptom control alone and is as effective as standard combination chemotherapy[1][3].

What is the projected market size for Topotecan Hydrochloride by 2031?

The global Topotecan Hydrochloride market is expected to reach USD 805.70 million by 2031, growing at a CAGR of 5.00% from 2024 to 2031[5].

Which region is expected to drive the growth of the Topotecan Hydrochloride market?

The Asia-Pacific region is projected to be the fastest-growing market, driven by increasing cancer prevalence, improving healthcare infrastructure, and rising investment in medical research[5].

What are the main market segments for Hycamtin?

Hospitals are the largest segment due to their comprehensive infrastructure, while specialty clinics are the fastest-growing segment due to their focus on personalized and advanced cancer treatments[5].

How does the introduction of biosimilars impact the market for Hycamtin?

The introduction of biosimilars can impact the sales of branded products like Hycamtin, but its unique positioning and efficacy are expected to maintain its market presence[2][5].

Sources

  1. European Medicines Agency. Hycamtin | European Medicines Agency (EMA).
  2. GlobalData. NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025.
  3. GlaxoSmithKline. GlaxoSmithKline Receives Approval for HYCAMTIN(R) (topotecan) Capsules for the Treatment of Relapsed Small Cell Lung Cancer.
  4. Novartis. HYCAMTIN FOR INJECTION.
  5. Cognitive Market Research. Topotecan Hydrochloride Sales Market Report 2024 (Global Edition).

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