CLINICAL TRIALS PROFILE FOR SULINDAC

All Clinical Trials for Sulindac

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00003365 ↗	Sulindac and Plant Compounds in Preventing Colon Cancer	Terminated	National Cancer Institute (NCI)	N/A	1996-08-01	RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of sulindac may be an effective way to prevent colon cancer. Eating a diet rich in fruits and vegetables appears to reduce the risk of some types of cancer. Curcumin, rutin, and quercetin are compounds found in plants that may prevent the development of colon cancer. PURPOSE: Randomized clinical trial to study the effectiveness of sulindac, curcumin, rutin, and quercetin in preventing colon cancer.
NCT00003365 ↗	Sulindac and Plant Compounds in Preventing Colon Cancer	Terminated	University of Medicine and Dentistry of New Jersey	N/A	1996-08-01	RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of sulindac may be an effective way to prevent colon cancer. Eating a diet rich in fruits and vegetables appears to reduce the risk of some types of cancer. Curcumin, rutin, and quercetin are compounds found in plants that may prevent the development of colon cancer. PURPOSE: Randomized clinical trial to study the effectiveness of sulindac, curcumin, rutin, and quercetin in preventing colon cancer.
NCT00005882 ↗	Eflornithine and Sulindac in Preventing Colorectal Cancer in Patients With Colon Polyps	Completed	Chao Family Comprehensive Cancer Center	Phase 3	1998-07-01	This randomized phase III trial is studying eflornithine and sulindac to see how well they work compared to a placebo in preventing colorectal cancer in patients with colon polyps. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of eflornithine and sulindac may prevent colorectal cancer. It is not yet known whether eflornithine and sulindac are more effective than a placebo in preventing colorectal cancer
NCT00005882 ↗	Eflornithine and Sulindac in Preventing Colorectal Cancer in Patients With Colon Polyps	Completed	National Cancer Institute (NCI)	Phase 3	1998-07-01	This randomized phase III trial is studying eflornithine and sulindac to see how well they work compared to a placebo in preventing colorectal cancer in patients with colon polyps. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of eflornithine and sulindac may prevent colorectal cancer. It is not yet known whether eflornithine and sulindac are more effective than a placebo in preventing colorectal cancer
NCT00005882 ↗	Eflornithine and Sulindac in Preventing Colorectal Cancer in Patients With Colon Polyps	Completed	University of California, Irvine	Phase 3	1998-07-01	This randomized phase III trial is studying eflornithine and sulindac to see how well they work compared to a placebo in preventing colorectal cancer in patients with colon polyps. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of eflornithine and sulindac may prevent colorectal cancer. It is not yet known whether eflornithine and sulindac are more effective than a placebo in preventing colorectal cancer
NCT00037609 ↗	Safety, Efficacy and Pharmacokinetic Between Capecitabine and Exisulind in Metastatic Breast Cancer Patients	Completed	Cell Pathways	Phase 1/Phase 2	2001-01-01	The primary objective of the phase I study is to determine a safe dose for combination therapy with capecitabine and exisulind. A secondary objective is to assess pharmacokinetic interactions between the two drugs and assess the biological activity of exisulind. The primary objective of the Phase II part of this study is to assess the anti-tumor activity of this combination therapy measured by objective tumor response. Secondary end points also assessed will be toxicity of therapy, duration of response and time to progression.
NCT00037609 ↗	Safety, Efficacy and Pharmacokinetic Between Capecitabine and Exisulind in Metastatic Breast Cancer Patients	Completed	M.D. Anderson Cancer Center	Phase 1/Phase 2	2001-01-01	The primary objective of the phase I study is to determine a safe dose for combination therapy with capecitabine and exisulind. A secondary objective is to assess pharmacokinetic interactions between the two drugs and assess the biological activity of exisulind. The primary objective of the Phase II part of this study is to assess the anti-tumor activity of this combination therapy measured by objective tumor response. Secondary end points also assessed will be toxicity of therapy, duration of response and time to progression.

Clinical Trial Conditions for Sulindac

Condition Name

Condition Name for Sulindac
Intervention	Trials
Precancerous Condition	5
Colorectal Cancer	4
Breast Cancer	3
Familial Adenomatous Polyposis	3

Condition MeSH

Condition MeSH for Sulindac
Intervention	Trials
Colorectal Neoplasms	10
Precancerous Conditions	6
Adenomatous Polyposis Coli	5
Nasopharyngeal Neoplasms	5

Clinical Trial Locations for Sulindac

Trials by Country

Trials by Country for Sulindac
Location	Trials
United States	102
Netherlands	2
United Kingdom	2
Canada	2
Puerto Rico	1

Trials by US State

Trials by US State for Sulindac
Location	Trials
Massachusetts	7
California	7
New York	7
Arizona	6
Minnesota	5

Clinical Trial Progress for Sulindac

Clinical Trial Phase

Clinical Trial Phase for Sulindac
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	5
Phase 2	18

Clinical Trial Status

Clinical Trial Status for Sulindac
Clinical Trial Phase	Trials
Completed	17
Terminated	6
Recruiting	3

Clinical Trial Sponsors for Sulindac

Sponsor Name

Sponsor Name for Sulindac
Sponsor	Trials
National Cancer Institute (NCI)	16
Cancer Prevention Pharmaceuticals, Inc.	4
Massachusetts General Hospital	3

Sponsor Type

Sponsor Type for Sulindac
Sponsor	Trials
Other	38
NIH	17
Industry	10

Sulindac: Clinical Trials, Market Analysis, and Projections

Introduction to Sulindac

Sulindac, a nonsteroidal anti-inflammatory drug (NSAID), has been widely used for its anti-inflammatory, analgesic, and antipyretic properties. However, its potential extends beyond these traditional uses, particularly in the realm of cancer prevention and treatment.

Clinical Trials Overview

Melanoma Prevention

One significant clinical trial involves the use of sulindac in preventing melanoma in healthy participants at increased risk. The Phase II trial, identified as NCT00841204, aims to determine whether sulindac is more effective than a placebo in preventing melanoma in individuals with multiple moles and abnormal moles. This trial, led by Dr. Susan M. Swetter, investigates sulindac's ability to block enzymes necessary for cell growth, potentially halting tumor cell proliferation[1].

Familial Adenomatous Polyposis (FAP)

Another critical area of research involves the use of sulindac in patients with Familial Adenomatous Polyposis (FAP), a genetic disorder leading to the development of numerous polyps in the colon and rectum. A randomized, double-blind Phase III trial evaluates the combination of eflornithine plus sulindac against sulindac or eflornithine alone in delaying FAP-related events. This study assesses the efficacy and safety of the combination treatment in preventing disease progression, including the need for excisional interventions and clinically important events such as cancer or death[4].

Study Objectives and Design

The FAP trial, as outlined in the Statistical Analysis Plan, involves a stratified randomization procedure based on FAP-related time-to-first-event prognosis. Patients are randomized to receive either the combination of eflornithine and sulindac, or one of the single agents with a placebo. The primary objective is to determine if the combination treatment is superior to single-agent treatments in delaying FAP-related events. The study includes interim analyses and a Data Monitoring Committee to oversee safety and efficacy data[3].

Market Analysis

Global Market Trends

The global sulindac market is subject to various trends and drivers. Market research reports indicate that the demand for sulindac is influenced by its applications in both traditional NSAID uses and emerging cancer prevention roles.

• Manufacturers and Suppliers: The market is characterized by several key manufacturers and suppliers, primarily located in Europe, Asia, and North America. These companies play a crucial role in the production and distribution of sulindac, influencing market dynamics[2][5].

• End-Use Sectors: Sulindac is used in various end-use sectors, including pharmaceuticals for its anti-inflammatory properties and in clinical trials for cancer prevention. The market analysis highlights the growing importance of sulindac in the pharmaceutical industry, particularly in the context of cancer research[2].

• Market Constraints and Opportunities: The global market analysis identifies several constraints, such as regulatory hurdles and competition from other NSAIDs. However, the potential for sulindac in cancer prevention presents significant opportunities for market growth and expansion[2][5].

Market Projections

The global sulindac market is projected to grow over the next few years, driven by increasing demand in the pharmaceutical sector and the ongoing research in cancer prevention.

• Forecast to 2030: Market research reports forecast the global sulindac market to continue growing until 2030, with a focus on emerging applications and expanding market reach. The reports provide detailed forecasts, including market size, trends, and regional analyses[5].

• Regional Analysis: The market is analyzed regionally, with Europe, Asia, and North America being key markets. The regional analysis helps in understanding the local demand, supply chain, and competitive landscape[2][5].

Pricing and Manufacturing

Pricing Data

The pricing of sulindac varies by region and is influenced by factors such as manufacturing costs, regulatory environments, and market demand. Market research reports provide detailed pricing data for different regions, helping stakeholders understand the economic viability of sulindac in various markets[2][5].

Manufacturing Methods

The manufacturing methods for sulindac are well-documented and involve several steps to ensure the quality and purity of the drug. The reports summarize data on manufacturing processes, highlighting the importance of adhering to strict safety and quality standards[2].

Patents and Intellectual Property

The sulindac market is also influenced by patents and intellectual property rights. Market research reports include chapters dedicated to related patents, which are crucial for understanding the competitive landscape and potential barriers to entry for new manufacturers[2].

Safety and Handling

Safety Information

Sulindac, like other NSAIDs, comes with safety considerations. The reports include detailed safety information, hazards identification, and handling and storage guidelines to ensure safe use and minimize risks[2].

Toxicological and Ecological Information

The toxicological and ecological impact of sulindac is also a focus area. The reports provide information on the environmental and health risks associated with sulindac, which is essential for regulatory compliance and sustainable practices[2].

Conclusion

Sulindac is a drug with a broad spectrum of applications, from traditional anti-inflammatory uses to emerging roles in cancer prevention. Clinical trials, particularly those focused on melanoma and FAP, highlight its potential in oncology. The global market for sulindac is expected to grow, driven by increasing demand and ongoing research.

Key Takeaways

• Clinical Trials: Sulindac is being studied for its potential in preventing melanoma and treating FAP.
• Market Growth: The global sulindac market is projected to grow, driven by pharmaceutical demand and emerging applications.
• Regional Analysis: Key markets include Europe, Asia, and North America, each with unique demand and supply dynamics.
• Pricing and Manufacturing: Pricing varies by region, and manufacturing processes are critical for ensuring quality and safety.
• Safety and Handling: Detailed safety information and handling guidelines are essential for minimizing risks.

FAQs

Q: What is the primary focus of the Phase II trial (NCT00841204) involving sulindac?

A: The primary focus is to determine whether sulindac is more effective than a placebo in preventing melanoma in individuals at increased risk.

Q: How does the combination of eflornithine and sulindac compare to single-agent treatments in FAP patients?

A: The combination is being evaluated for its superiority in delaying FAP-related events compared to single-agent treatments.

Q: What regions are key markets for sulindac?

A: Europe, Asia, and North America are the primary regions for the sulindac market.

Q: What are the main drivers for the growth of the global sulindac market?

A: The growth is driven by increasing demand in the pharmaceutical sector and ongoing research in cancer prevention.

Q: Where can one find detailed pricing data for sulindac?

A: Market research reports provide detailed pricing data for different regions, which can be obtained from market analysis reports.

Sources

1. Stanford Health Care: Sulindac in Preventing Melanoma in Healthy Participants Who Are at Increased Risk of Melanoma.
2. Research and Markets: Sulindac (CAS 38194-50-2) Global Market Research Report 2024.
3. ClinicalTrials.gov: Statistical Analysis Plan - Trial of Eflornithine Plus Sulindac in Patients with Familial Adenomatous Polyposis.
4. Mayo Clinic: Trial of Eflornithine Plus Sulindac in Patients with Familial Adenomatous Polyposis.
5. Market Research Reports: Global Sulindac Market 2024 by Manufacturers, Regions, Type and Application, Forecast to 2030.

Last updated: 2025-01-01