CLINICAL TRIALS PROFILE FOR FLUOROPLEX

All Clinical Trials for Fluoroplex

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00083109 ↗	Fluorouracil and Low-Dose Suramin as Chemosensitization in Treating Patients With Metastatic Renal Cell (Kidney) Cancer	Completed	National Cancer Institute (NCI)	Phase 1/Phase 2	2004-03-01	Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Suramin may increase the effectiveness of fluorouracil by making tumor cells more sensitive to the drug. This phase I/II trial is studying the side effects and best dose of fluorouracil and the chemosensitizer suramin and to see how well they work in treating patients with metastatic renal cell (kidney) cancer.
NCT00324415 ↗	Combined Modality Therapy for Patients With With HIV and Stage I, Stage II, or Stage III Anal Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2006-09-01	RATIONALE: Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cisplatin, fluorouracil, and cetuximab together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cisplatin, fluorouracil, and cetuximab together with radiation therapy works in treating patients with HIV and stage I, stage II, or stage III anal cancer.
NCT00324415 ↗	Combined Modality Therapy for Patients With With HIV and Stage I, Stage II, or Stage III Anal Cancer	Completed	The Emmes Company, LLC	Phase 2	2006-09-01	RATIONALE: Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cisplatin, fluorouracil, and cetuximab together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cisplatin, fluorouracil, and cetuximab together with radiation therapy works in treating patients with HIV and stage I, stage II, or stage III anal cancer.
NCT00324415 ↗	Combined Modality Therapy for Patients With With HIV and Stage I, Stage II, or Stage III Anal Cancer	Completed	The EMMES Corporation	Phase 2	2006-09-01	RATIONALE: Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cisplatin, fluorouracil, and cetuximab together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cisplatin, fluorouracil, and cetuximab together with radiation therapy works in treating patients with HIV and stage I, stage II, or stage III anal cancer.
NCT00324415 ↗	Combined Modality Therapy for Patients With With HIV and Stage I, Stage II, or Stage III Anal Cancer	Completed	AIDS Malignancy Consortium	Phase 2	2006-09-01	RATIONALE: Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cisplatin, fluorouracil, and cetuximab together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cisplatin, fluorouracil, and cetuximab together with radiation therapy works in treating patients with HIV and stage I, stage II, or stage III anal cancer.
NCT00417976 ↗	Gemcitabine, Infusional 5 Fluorouracil and Bevacizumab in Patients With Advanced Pancreas Cancer	Completed	Genentech, Inc.	Phase 2	2006-12-01	This is a phase II study of biweekly (every other week) bevacizumab followed by gemcitabine then infusional 5-fluorouracil in patients with stage III or IV pancreatic cancer. Patients' response will be evaluated every 8 weeks using usual CT scanning techniques. RECIST (Response Evaluation Criteria in Solid tumors) criteria will be applied to evaluate response. Tumor marker levels (Ca 19-9) will be assessed every 4 weeks, but will not be used to measure response.
NCT00417976 ↗	Gemcitabine, Infusional 5 Fluorouracil and Bevacizumab in Patients With Advanced Pancreas Cancer	Completed	Tony Bekaii-Saab	Phase 2	2006-12-01	This is a phase II study of biweekly (every other week) bevacizumab followed by gemcitabine then infusional 5-fluorouracil in patients with stage III or IV pancreatic cancer. Patients' response will be evaluated every 8 weeks using usual CT scanning techniques. RECIST (Response Evaluation Criteria in Solid tumors) criteria will be applied to evaluate response. Tumor marker levels (Ca 19-9) will be assessed every 4 weeks, but will not be used to measure response.

Clinical Trial Conditions for Fluoroplex

Condition Name

Condition Name for Fluoroplex
Intervention	Trials
Metastatic Pancreatic Adenocarcinoma	3
Stage IV Pancreatic Cancer	3
Recurrent Pancreatic Carcinoma	2
Stage III Pancreatic Cancer	2

Condition MeSH

Condition MeSH for Fluoroplex
Intervention	Trials
Carcinoma	6
Pancreatic Neoplasms	6
Adenocarcinoma	5
Colorectal Neoplasms	3

Clinical Trial Locations for Fluoroplex

Trials by Country

Trials by Country for Fluoroplex
Location	Trials
United States	162
Japan	11
Canada	10
Spain	8
Belgium	7

Trials by US State

Trials by US State for Fluoroplex
Location	Trials
California	8
Ohio	8
New York	7
Georgia	6
Arizona	6

Clinical Trial Progress for Fluoroplex

Clinical Trial Phase

Clinical Trial Phase for Fluoroplex
Clinical Trial Phase	Trials
Phase 3	3
Phase 2/Phase 3	1
Phase 2	7

Clinical Trial Status

Clinical Trial Status for Fluoroplex
Clinical Trial Phase	Trials
Completed	9
Recruiting	4
Terminated	3

Clinical Trial Sponsors for Fluoroplex

Sponsor Name

Sponsor Name for Fluoroplex
Sponsor	Trials
National Cancer Institute (NCI)	12
Boston Biomedical, Inc	3
Sumitomo Dainippon Pharma Oncology, Inc	3

Sponsor Type

Sponsor Type for Fluoroplex
Sponsor	Trials
NIH	12
Industry	12
Other	12

Fluoroplex: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction to Fluoroplex

Fluoroplex, a topical formulation containing fluorouracil, is a crucial drug in the treatment of actinic keratosis, a precursor to skin cancer. Here, we will delve into the clinical trials, market analysis, and future projections for Fluoroplex.

Clinical Trials and Efficacy

Phase 3 Trials and Safety Evaluation

Clinical trials for Fluoroplex, similar to those for Tolak (another fluorouracil cream), involve rigorous evaluations of efficacy and safety. In the case of Tolak, two Phase 3 trials (Studies 48 and 49) were conducted to assess the efficacy and safety of the drug compared to Efudex and vehicle controls. These studies demonstrated statistical superiority of Tolak over the vehicle but did not establish noninferiority to Efudex[1].

Long-Term Follow-Up Studies

Study 50, a long-term follow-up study, was designed to evaluate the re-treatment outcomes and long-term safety of subjects who had received Tolak in the previous studies. This study enrolled 310 subjects and provided valuable data on the 12-month outcomes, which were crucial for understanding the sustained efficacy and safety profile of the drug[1].

Market Analysis for Fluoroplex

Current Market Size and Growth

The U.S. actinic keratosis treatment market, in which Fluoroplex is a key player, was valued at USD 2.32 billion in 2022. This market is expected to expand at a compound annual growth rate (CAGR) of 3.03% during the forecast period. The topical/drugs segment, particularly nucleoside metabolic inhibitors like Fluoroplex, Carac, and Efudex, dominates this market due to strong commercial performance and high demand for topical formulations[3].

Market Share and Competition

Fluoroplex, along with other fluorouracil-based creams, holds a significant market share in the actinic keratosis treatment market. The rising awareness about the diagnosis and treatment of actinic keratosis has further fueled the growth of this segment. The competition in this market is driven by the performance of these topical formulations and their efficacy in treating the initial stages of the condition[3].

Market Projections and Trends

Forecasted Growth

The actinic keratosis treatment market, driven by the demand for topical treatments like Fluoroplex, is expected to continue its growth trajectory. With an anticipated CAGR of 3.03%, the market is projected to expand significantly over the next few years. This growth is attributed to increasing awareness, better diagnostic techniques, and the preference for topical treatments over more invasive procedures[3].

Regional Market Dynamics

While the U.S. market is a significant segment for Fluoroplex, global trends also play a crucial role. The demand for fluorouracil-based treatments is expected to rise globally, driven by increasing skin cancer incidence rates and the need for effective topical treatments.

End-User Industries and Applications

Industrial and Medical Applications

Although Fluoroplex is primarily used in dermatology, the broader category of fluoropolymers, which includes fluorouracil, has diverse applications. In industrial and medical fields, fluoropolymers are valued for their unique properties such as non-stick surfaces, chemical resistance, and high temperature tolerance. The industrial and machinery sector dominates the fluoropolymer market, but medical applications are also a significant growth area[2][5].

Key Factors Driving Market Growth

Advancements in Medical Applications

Advancements in medical applications, including the development of new topical formulations and improved delivery systems, are driving the growth of the Fluoroplex market. The high demand for effective and safe treatments for actinic keratosis and other skin conditions is a key factor[3].

High Demand in End-Use Industries

The high demand in end-use industries such as automotive and industrial sectors, although not directly related to Fluoroplex, indicates the broader market potential for fluorouracil and fluoropolymer-based products. This demand is driven by the unique properties of these materials, which are essential in various applications[2][5].

Challenges and Opportunities

Regulatory Approvals and Labeling

One of the challenges faced by Fluoroplex and similar drugs is the rigorous regulatory approval process. Ensuring compliance with FDA guidelines and resolving pending issues such as labeling negotiations are critical steps before full market approval[1].

Increasing Awareness and Diagnosis

The increasing awareness about actinic keratosis and its treatment options presents a significant opportunity for Fluoroplex. As more patients are diagnosed and treated, the demand for effective topical treatments is expected to rise, driving market growth[3].

Key Takeaways

• Clinical Efficacy: Fluoroplex has demonstrated efficacy in treating actinic keratosis through clinical trials, although long-term follow-up studies are crucial for understanding sustained outcomes.
• Market Growth: The U.S. actinic keratosis treatment market is expected to grow at a CAGR of 3.03%, driven by the demand for topical treatments.
• Regulatory Compliance: Ensuring regulatory compliance and resolving pending issues are essential for full market approval.
• Increasing Awareness: Rising awareness about actinic keratosis diagnosis and treatment is a key driver of market growth.

FAQs

What is Fluoroplex used for?

Fluoroplex is used for the treatment of actinic keratosis, a precursor to skin cancer.

What are the key clinical trials for Fluoroplex?

The key clinical trials for Fluoroplex involve Phase 3 studies to evaluate efficacy and safety, as well as long-term follow-up studies to assess sustained outcomes.

What is the current market size of the U.S. actinic keratosis treatment market?

The U.S. actinic keratosis treatment market was valued at USD 2.32 billion in 2022.

What is the projected growth rate of the U.S. actinic keratosis treatment market?

The market is expected to expand at a CAGR of 3.03% during the forecast period.

What are the main factors driving the growth of the Fluoroplex market?

The main factors include advancements in medical applications, high demand for topical treatments, and increasing awareness about actinic keratosis diagnosis and treatment.

Sources

1. FDA Clinical Review: "NDA 22-259 Tolak (fluorouracil) Cream, 4%" - accessdata.fda.gov
2. Mordor Intelligence: "Fluoropolymer Market Size & Share Analysis - Growth Trends" - mordorintelligence.com
3. Grand View Research: "U.S. Actinic Keratosis Treatment Market Size Report, 2030" - grandviewresearch.com
4. PubMed: "Upfront Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan Plus Bevacizumab With or Without Atezolizumab in Metastatic Colorectal Cancer" - pubmed.ncbi.nlm.nih.gov
5. Zion Market Research: "Fluoropolymers Market Size, Share, Report Scope & Forecast 2032" - zionmarketresearch.com

Last updated: 2025-01-06