CLINICAL TRIALS PROFILE FOR ELDECORT

All Clinical Trials for Eldecort

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00536991 ↗	Calcitriol in Combination With Ketoconazole and Therapeutic Hydrocortisone in Treating Patients With Prostate Cancer	Terminated	National Cancer Institute (NCI)	Phase 1/Phase 2	2006-10-01	This phase I/II trial studies the side effects and best dose of calcitriol when given in combination with ketoconazole and therapeutic hydrocortisone and to see how well it works in treating patients with prostate cancer. Calcitriol may help prostate cancer cells become more like normal cells and grow and spread more slowly. Ketoconazole and therapeutic hydrocortisone may help calcitriol work better by making tumor cells more sensitive to the drug. Giving calcitriol together with ketoconazole and therapeutic hydrocortisone may be a better treatment for prostate cancer.
NCT00536991 ↗	Calcitriol in Combination With Ketoconazole and Therapeutic Hydrocortisone in Treating Patients With Prostate Cancer	Terminated	Roswell Park Cancer Institute	Phase 1/Phase 2	2006-10-01	This phase I/II trial studies the side effects and best dose of calcitriol when given in combination with ketoconazole and therapeutic hydrocortisone and to see how well it works in treating patients with prostate cancer. Calcitriol may help prostate cancer cells become more like normal cells and grow and spread more slowly. Ketoconazole and therapeutic hydrocortisone may help calcitriol work better by making tumor cells more sensitive to the drug. Giving calcitriol together with ketoconazole and therapeutic hydrocortisone may be a better treatment for prostate cancer.
NCT00557193 ↗	Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia	Active, not recruiting	National Cancer Institute (NCI)	Phase 3	2008-01-14	This phase III trial studies combination chemotherapy with or without lestaurtinib with to see how well they work in treating younger patients with newly diagnosed acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of stop cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lestaurtinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether combination chemotherapy is more effective with or without lestaurtinib in treating acute lymphoblastic leukemia.
NCT00557193 ↗	Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia	Active, not recruiting	Children's Oncology Group	Phase 3	2008-01-14	This phase III trial studies combination chemotherapy with or without lestaurtinib with to see how well they work in treating younger patients with newly diagnosed acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of stop cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lestaurtinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether combination chemotherapy is more effective with or without lestaurtinib in treating acute lymphoblastic leukemia.
NCT01867294 ↗	Spironolactone in Preventing Rash in Patients With Advanced Cancer Receiving Panitumumab and Cetuximab	Completed	National Cancer Institute (NCI)	Phase 2	2012-08-31	This randomized phase II trial studies how well giving spironolactone works in preventing rash in patients with cancer that has spread to other places in the body and are receiving panitumumab and cetuximab. Spironolactone may prevent endothelial growth factor receptor (EGFR) inhibitor-induced skin rash.
NCT01867294 ↗	Spironolactone in Preventing Rash in Patients With Advanced Cancer Receiving Panitumumab and Cetuximab	Completed	Academic and Community Cancer Research United	Phase 2	2012-08-31	This randomized phase II trial studies how well giving spironolactone works in preventing rash in patients with cancer that has spread to other places in the body and are receiving panitumumab and cetuximab. Spironolactone may prevent endothelial growth factor receptor (EGFR) inhibitor-induced skin rash.
NCT02101853 ↗	Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia	Active, not recruiting	National Cancer Institute (NCI)	Phase 3	2014-12-08	This randomized phase III trial studies how well blinatumomab works compared with standard combination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that has returned after a period of improvement (relapsed). Immunotherapy with blinatumomab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether standard combination chemotherapy is more effective than blinatumomab in treating relapsed B-cell acute lymphoblastic leukemia.

Clinical Trial Conditions for Eldecort

Condition Name

Condition Name for Eldecort
Intervention	Trials
Untreated Childhood Acute Lymphoblastic Leukemia	2
B Acute Lymphoblastic Leukemia	2
Acute Lymphoblastic Leukemia	2
Dermatologic Complication	1

Condition MeSH

Condition MeSH for Eldecort
Intervention	Trials
Leukemia	4
Precursor Cell Lymphoblastic Leukemia-Lymphoma	3
Leukemia, Lymphoid	3
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma	2

Clinical Trial Locations for Eldecort

Trials by Country

Trials by Country for Eldecort
Location	Trials
United States	213
Canada	30
Australia	5
New Zealand	5
Puerto Rico	3

Trials by US State

Trials by US State for Eldecort
Location	Trials
Illinois	7
New York	6
Ohio	6
Minnesota	6
Massachusetts	6

Clinical Trial Progress for Eldecort

Clinical Trial Phase

Clinical Trial Phase for Eldecort
Clinical Trial Phase	Trials
Phase 3	4
Phase 2	1
Phase 1/Phase 2	2

Clinical Trial Status

Clinical Trial Status for Eldecort
Clinical Trial Phase	Trials
Active, not recruiting	4
Recruiting	2
Completed	1

Clinical Trial Sponsors for Eldecort

Sponsor Name

Sponsor Name for Eldecort
Sponsor	Trials
National Cancer Institute (NCI)	8
Children's Oncology Group	4
Roswell Park Cancer Institute	1

Sponsor Type

Sponsor Type for Eldecort
Sponsor	Trials
NIH	8
Other	8
Industry	1

Clinical Trials, Market Analysis, and Projections for Drugs: A Case Study on Eldecort

Introduction to Clinical Trials

Clinical trials are a crucial step in the development and approval of new drugs, including those like Eldecort. These trials are meticulously regulated to ensure patient safety and the integrity of the data collected. Here’s a comprehensive overview of the process and its implications for market analysis and projections.

Phases of Clinical Trials

Clinical trials are divided into several phases, each serving a distinct purpose:

Phase 1

• This phase involves the first human testing of the drug, typically with a small group of participants. It focuses on safety, tolerability, and pharmacokinetics[1].

Phase 2

• In this phase, the drug is tested on a larger group to evaluate its efficacy and side effects. It also includes dose-finding and dose-response trials[1].

Phase 3

• These trials are conducted on a larger scale, often involving more than 300 participants. They assess the efficacy and safety of the drug in comparison to existing treatments or placebos. Phase 3 trials are pivotal for pre-marketing approval and must meet specific criteria, such as prior approval in the USA or EU or previous MHRA approval for similar trials[1].

Phase 4

• Post-marketing trials that monitor the drug's long-term effects and any rare adverse reactions in a larger population[1].

Streamlined Clinical Trial Processes

To expedite the clinical trial process, regulatory bodies have introduced streamlined approaches. For example, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has a new Notification Scheme that allows for faster processing of clinical trial authorizations (CTA) for lower-risk Phase 3 and Phase 4 trials. This scheme reduces the processing time from 30 days to 14 days, provided the trial meets specific inclusion criteria[1].

Market Analysis for Pharmaceutical Drugs

Global Market Trends

The global pharmaceutical market is driven by the demand for innovative healthcare solutions. Here are some key trends:

• U.S. Clinical Trials Market: Expected to grow from USD 27.07 billion in 2024 to USD 41.57 billion by 2033, driven by ongoing research and the need to enhance patient care. Phase III trials hold the largest share, while Phase I studies are anticipated to register the fastest growth rate[3].

• Therapeutic Areas: Oncology and autoimmune segments are among the most lucrative, with oncology expected to register the fastest CAGR over the forecast period. For instance, the heart failure market, dominated by drugs like Entresto, has shown significant growth rates[2][3].

Specific Market Segments

Cardiovascular Market

• The cardiovascular market, including segments like heart failure and thrombosis, is highly competitive. Drugs like Eliquis and Xarelto dominate the market for embolism and thrombosis, while Entresto leads in the heart failure segment with rapid growth rates[2].

Endocrine and Metabolic Market

• This market also sees significant growth, particularly in areas like type 2 diabetes and related complications. Drugs originally approved for type 2 diabetes, such as Forxiga and Jardiance, are now entering the heart failure market with impressive growth rates[2].

Precision Medicine and Clinical Trials

Precision medicine, which involves tailoring treatments to individual genetic profiles, is a growing area in clinical trials.

ComboMATCH Trials

• The ComboMATCH trials, supported by the National Cancer Institute (NCI), assign patients to combination therapies based on the genetic characteristics of their tumors. This approach has shown promise in treating cancer by targeting specific genetic changes rather than the type of cancer[4].

Market Projections for New Drugs

Factors Influencing Market Success

• Regulatory Approvals: Timely and favorable regulatory approvals are crucial. Streamlined processes like the MHRA's Notification Scheme can expedite this[1].
• Competitive Landscape: Understanding the existing market dynamics and competitive landscape is essential. For example, in the cardiovascular market, new drugs must compete with established brands like Eliquis and Entresto[2].
• Innovative Therapies: The adoption of precision medicine and innovative therapies can significantly impact market success. Trials like ComboMATCH demonstrate the potential of targeted treatments[4].

Projecting Market Performance for Eldecort

To project the market performance of a drug like Eldecort, several factors need to be considered:

• Clinical Trial Outcomes: Successful Phase 3 trials and subsequent regulatory approvals are critical.
• Market Demand: The demand for the drug's therapeutic area and the competitive landscape will influence its market share.
• Innovation and Differentiation: If Eldecort offers unique benefits or targets a specific genetic profile, it could gain a competitive edge.

Key Takeaways

• Streamlined Regulatory Processes: Faster processing times for clinical trial authorizations can accelerate drug development.
• Market Trends: The pharmaceutical market is driven by demand for innovative solutions, with oncology and autoimmune segments showing significant growth.
• Precision Medicine: Targeted therapies based on genetic profiles are becoming more prevalent and promising.
• Competitive Landscape: Understanding the existing market and competitive dynamics is crucial for new drug success.

FAQs

What are the different phases of clinical trials?

Clinical trials are divided into Phase 1 (first human testing for safety), Phase 2 (efficacy and side effects), Phase 3 (large-scale efficacy and safety), and Phase 4 (post-marketing long-term effects).

How do streamlined clinical trial processes work?

Streamlined processes, like the MHRA's Notification Scheme, reduce processing times for lower-risk Phase 3 and Phase 4 trials from 30 days to 14 days if specific criteria are met.

What is the significance of precision medicine in clinical trials?

Precision medicine involves tailoring treatments to individual genetic profiles, as seen in trials like ComboMATCH, which has shown promise in treating cancer by targeting specific genetic changes.

How do market trends influence the success of new drugs?

Market trends, such as the demand for innovative solutions and the competitive landscape in specific therapeutic areas, significantly influence the success of new drugs.

What factors are crucial for projecting the market performance of a new drug?

Factors such as clinical trial outcomes, market demand, and the drug's innovative features or differentiation are crucial for projecting market performance.

Sources

1. GOV.UK: Clinical trials for medicines: apply for authorisation in the UK.
2. IQVIA: Finding the growth engines of the endocrine & metabolic.
3. Biospace: U.S. Clinical Trials Market Size Industry Analysis Report, 2033.
4. National Cancer Institute: ComboMATCH Precision Medicine Cancer Trials.