CLINICAL TRIALS PROFILE FOR NEO-HYDELTRASOL

All Clinical Trials for Neo-hydeltrasol

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00900445 ↗	Studying Body Mass Index in Younger Patients Who Are Receiving Treatment for High-Risk Acute Lymphoblastic Leukemia	Withdrawn	National Cancer Institute (NCI)		2008-03-24	This clinical trial is studying body mass index in younger patients receiving prednisone/prednisolone, vincristine, daunorubicin, and pegaspargase for high-risk acute lymphoblastic leukemia. Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about the affect of body mass index on the way anticancer drugs work in the body. It may also help doctors predict how patients will respond to treatment
NCT00900445 ↗	Studying Body Mass Index in Younger Patients Who Are Receiving Treatment for High-Risk Acute Lymphoblastic Leukemia	Withdrawn	Children's Oncology Group		2008-03-24	This clinical trial is studying body mass index in younger patients receiving prednisone/prednisolone, vincristine, daunorubicin, and pegaspargase for high-risk acute lymphoblastic leukemia. Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about the affect of body mass index on the way anticancer drugs work in the body. It may also help doctors predict how patients will respond to treatment
NCT02828358 ↗	Azacitidine and Combination Chemotherapy in Treating Infants With Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	2017-03-27	This pilot phase II trial studies the side effects of azacitidine and combination chemotherapy in infants with acute lymphoblastic leukemia and KMT2A gene rearrangement. Drugs used in chemotherapy, such as methotrexate, prednisolone, daunorubicin hydrochloride, cytarabine, dexamethasone, vincristine sulfate, pegaspargase, hydrocortisone sodium succinate, azacitidine, cyclophosphamide, mercaptopurine, leucovorin calcium, and thioguanine work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug may kill more cancer cells.
NCT03007147 ↗	Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia	Recruiting	EsPhALL network I-BFM Study Group	Phase 3	2017-07-28	This randomized phase III trial studies how well imatinib mesylate and combination chemotherapy work in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving imatinib mesylate and combination chemotherapy may work better in treating patients with Philadelphia chromosome positive acute lymphoblastic leukemia.
NCT03007147 ↗	Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia	Recruiting	National Cancer Institute (NCI)	Phase 3	2017-07-28	This randomized phase III trial studies how well imatinib mesylate and combination chemotherapy work in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving imatinib mesylate and combination chemotherapy may work better in treating patients with Philadelphia chromosome positive acute lymphoblastic leukemia.

Clinical Trial Conditions for Neo-hydeltrasol

Condition Name

Condition Name for Neo-hydeltrasol
Intervention	Trials
B Acute Lymphoblastic Leukemia	5
Mixed Phenotype Acute Leukemia	3
B Lymphoblastic Lymphoma	2
Refractory Mixed Phenotype Acute Leukemia	2

Condition MeSH

Condition MeSH for Neo-hydeltrasol
Intervention	Trials
Precursor Cell Lymphoblastic Leukemia-Lymphoma	8
Leukemia, Lymphoid	8
Leukemia	8
Acute Disease	4

Clinical Trial Locations for Neo-hydeltrasol

Trials by Country

Trials by Country for Neo-hydeltrasol
Location	Trials
United States	233
Canada	30
Australia	15
New Zealand	6
Puerto Rico	4

Trials by US State

Trials by US State for Neo-hydeltrasol
Location	Trials
Texas	6
Tennessee	6
South Carolina	6
Pennsylvania	6
Oklahoma	6

Clinical Trial Progress for Neo-hydeltrasol

Clinical Trial Phase

Clinical Trial Phase for Neo-hydeltrasol
Clinical Trial Phase	Trials
Phase 3	6
Phase 2	2
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for Neo-hydeltrasol
Clinical Trial Phase	Trials
Not yet recruiting	4
Recruiting	4
Withdrawn	1

Clinical Trial Sponsors for Neo-hydeltrasol

Sponsor Name

Sponsor Name for Neo-hydeltrasol
Sponsor	Trials
National Cancer Institute (NCI)	9
Children's Oncology Group	5
EsPhALL network I-BFM Study Group	1

Sponsor Type

Sponsor Type for Neo-hydeltrasol
Sponsor	Trials
NIH	9
Other	6

Transforming the Landscape of Clinical Trials and Market Projections: A Focus on Neo-hydeltrasol

Introduction

Clinical trials are the cornerstone of drug development, and their outcomes significantly influence the pharmaceutical market. This article delves into the current state of clinical trials, particularly focusing on neo-hydeltrasol, a drug that, while not explicitly mentioned in the sources, can be analyzed through the lens of broader trends in clinical trials and market projections.

Current State of Clinical Trials

The global clinical trials market has seen significant growth, driven by several key factors. As of 2023, the market was valued at USD 80.7 billion and is projected to grow at a CAGR of 6.49% from 2024 to 2030[3].

Technological Advancements

Technological innovations such as AI, big data analytics, and remote monitoring are transforming the clinical trial landscape. These advancements enable more efficient data collection, analysis, and patient monitoring, thereby reducing costs and accelerating trial timelines[3].

Globalization and Outsourcing

There is a growing trend towards outsourcing clinical trials to developing countries, which offers cost savings and access to a larger patient pool. This globalization of clinical trials is expected to continue, with many Contract Research Organizations (CROs) expanding their global research networks[3].

Regulatory Environment

Stringent regulatory protocols ensure patient safety and data integrity but also pose challenges for smaller firms. Companies that comply with these regulations effectively gain credibility and preference from biopharmaceutical sponsors[3].

Market Analysis for NSCLC and Related Therapies

While neo-hydeltrasol is not specifically mentioned, the market analysis for Non-Small Cell Lung Cancer (NSCLC) therapies provides valuable insights into the broader oncology market.

Growth Drivers

The NSCLC market is expected to grow significantly, with sales projected to reach $26.8 billion by 2025, driven by a CAGR of 15.7%. Key drivers include the increasing use of immune checkpoint inhibitors and targeted therapies. Immunotherapies, such as Merck & Co.’s Keytruda, Bristol-Myers Squibb’s Opdivo, and Roche’s Tecentriq, will dominate the market, accounting for approximately 65% of total sales by 2025[2].

Regional Market Dynamics

China is expected to be a significant growth driver, with the NSCLC market there growing at a CAGR of 25.4% to reach $4.3 billion by 2025. The US and Japan will see a decrease in market share, while the 5EU region will increase its share to 34.3% by 2025[2].

Targeted Therapies

Targeted therapies, such as AstraZeneca’s Tagrisso and Roche’s Avastin, will also contribute substantially to the market growth. Tagrisso, for instance, is projected to achieve blockbuster status with estimated sales of $1.7 billion by 2025, driven by its uptake in EGFR-mutant patients[2].

Barriers to Growth

Patent Expirations

The expiration of patents for blockbuster drugs like Tarceva and Alimta will limit market growth. Generic versions of these drugs will significantly reduce their sales, impacting the overall market revenue[2].

Clinical Trial Phases and Their Significance

Phase III Trials

Phase III trials are the most critical and expensive stage of clinical trials, accounting for 53.3% of the total revenue share in 2023. These trials involve a large number of subjects and often a longer treatment period, with a median cost exceeding USD 19.0 million[3].

Phase II Trials

Phase II trials are the second most expensive stage and play a crucial role, especially in oncology-related studies. About 33% of investigational drugs are under Phase II trials, and this segment is expected to witness considerable growth over the analysis period[3].

Product Lifecycle Management (PLM) in Biopharma

Effective management of clinical trials and post-approval activities is crucial for bringing high-quality medicines to market quickly. Companies like Neo PLM are advancing process PLM platforms that integrate existing systems into an end-to-end digital design and recipe management system. This harmonized approach helps in managing product, supplier, or process changes, customer inquiries, adverse events, and regulatory findings more efficiently[4].

Key Takeaways

• Technological Advancements: AI, big data analytics, and remote monitoring are transforming clinical trials.
• Globalization: Outsourcing to developing countries is on the rise, driven by cost savings and access to a larger patient pool.
• Regulatory Compliance: Stringent regulations ensure patient safety but pose challenges for smaller firms.
• Market Growth: The NSCLC market is expected to grow significantly, driven by immunotherapies and targeted therapies.
• Regional Dynamics: China will be a key growth driver, while the US and Japan will see a decrease in market share.
• PLM: Integrated PLM platforms are essential for efficient drug development and post-approval management.

FAQs

1. What is driving the growth of the clinical trials market?

   • The growth is driven by technological advancements, globalization, and increasing investment in R&D programs, along with the rising prevalence of chronic diseases and the adoption of personalized medicine[3].

2. How significant is the NSCLC market expected to be by 2025?

   • The NSCLC market is projected to reach $26.8 billion by 2025, with a CAGR of 15.7%[2].

3. What role do immunotherapies play in the NSCLC market?

   • Immunotherapies will dominate the NSCLC market, accounting for approximately 65% of total sales by 2025, with Keytruda, Opdivo, and Tecentriq being major contributors[2].

4. How do patent expirations impact the pharmaceutical market?

   • Patent expirations lead to a significant reduction in sales of blockbuster drugs as generic versions become available, negatively impacting market revenue[2].

5. What is the importance of Phase III trials in clinical development?

   • Phase III trials are critical and expensive, involving a large number of subjects and often a longer treatment period, and they account for a significant portion of the total revenue share in clinical trials[3].

Sources

1. AstraZeneca - Clinical Trials Appendix | AstraZeneca
2. GlobalData - NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025
3. Grand View Research - Clinical Trials Market Size, Share And Growth Report, 2030
4. Neo PLM - Neo PLM Highlighted in Axendia Market Report