CLINICAL TRIALS PROFILE FOR NILOTINIB HYDROCHLORIDE

All Clinical Trials for Nilotinib Hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00036738 ↗	Fludarabine Phosphate and Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate, D	Completed	National Cancer Institute (NCI)	Phase 2	2001-07-13	This phase II trial is studying how well fludarabine phosphate and total-body irradiation followed by donor peripheral blood stem cell transplant work in treating patients with acute lymphoblastic leukemia or chronic myelogenous leukemia that has responded to previous treatment with imatinib mesylate, dasatinib, or nilotinib. Giving low doses of chemotherapy, such as fludarabine phosphate, and total-body irradiation (TBI) before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving mycophenolate mofetil and cyclosporine after the transplant may stop this from happening.
NCT00036738 ↗	Fludarabine Phosphate and Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate, D	Completed	Fred Hutchinson Cancer Research Center	Phase 2	2001-07-13	This phase II trial is studying how well fludarabine phosphate and total-body irradiation followed by donor peripheral blood stem cell transplant work in treating patients with acute lymphoblastic leukemia or chronic myelogenous leukemia that has responded to previous treatment with imatinib mesylate, dasatinib, or nilotinib. Giving low doses of chemotherapy, such as fludarabine phosphate, and total-body irradiation (TBI) before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving mycophenolate mofetil and cyclosporine after the transplant may stop this from happening.
NCT00109707 ↗	A Study of Oral AMN107 in Adults With Chronic Myelogenous Leukemia (CML) or Other Hematologic Malignancies	Completed	Novartis Pharmaceuticals	Phase 1/Phase 2	2005-04-01	The purpose of this trial is to assess the efficacy, safety, tolerability, biologic activity, and pharmacokinetics of AMN107 in six groups of patients with one of the following conditions: Relapsed/refractory Ph+ Acute lymphoblastic leukemia (ALL) (arm 1) Group A - Imatinib failure only (arms 2, 3 and 4) - imatinib-resistant or intolerant CML - Chronic Phase (CP) - imatinib-resistant or intolerant CML - Accelerated Phase (AP) - imatinib-resistant or intolerant CML - Blast Crisis (BC) Group B - Imatinib and other TKI failure (arms 2, 3 and 4) - imatinib-resistant or intolerant CML - Chronic Phase (CP) - imatinib-resistant or intolerant CML - Accelerated Phase (AP) - imatinib-resistant or intolerant CML - Blast Crisis (BC) Hypereosinophilic syndrome/chronic eosinophilic leukemia (HES/CEL) (arm 5) Systemic mastocytosis (Sm) (arm 6)
NCT00129740 ↗	Phase II Nilotinib With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML)	Completed	Novartis	Phase 2	2005-06-27	The goal of this clinical research study is to learn if an experimental agent, AMN107 (nilotinib), can help to control CML in chronic phase. The safety of this experimental agent will also be studied.
NCT00129740 ↗	Phase II Nilotinib With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML)	Completed	M.D. Anderson Cancer Center	Phase 2	2005-06-27	The goal of this clinical research study is to learn if an experimental agent, AMN107 (nilotinib), can help to control CML in chronic phase. The safety of this experimental agent will also be studied.

Clinical Trial Conditions for Nilotinib Hydrochloride

Condition Name

Condition Name for Nilotinib Hydrochloride
Intervention	Trials
Chronic Myeloid Leukemia	40
Chronic Myelogenous Leukemia	17
Leukemia	11
Gastrointestinal Stromal Tumors	10

Condition MeSH

Condition MeSH for Nilotinib Hydrochloride
Intervention	Trials
Leukemia, Myelogenous, Chronic, BCR-ABL Positive	117
Leukemia	114
Leukemia, Myeloid	107
Philadelphia Chromosome	33

Clinical Trial Locations for Nilotinib Hydrochloride

Trials by Country

Trials by Country for Nilotinib Hydrochloride
Location	Trials
United States	446
Italy	219
Japan	104
Spain	102
France	67

Trials by US State

Trials by US State for Nilotinib Hydrochloride
Location	Trials
Texas	35
California	26
New York	23
Florida	21
Illinois	20

Clinical Trial Progress for Nilotinib Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Nilotinib Hydrochloride
Clinical Trial Phase	Trials
Phase 4	17
Phase 3	33
Phase 2	86

Clinical Trial Status

Clinical Trial Status for Nilotinib Hydrochloride
Clinical Trial Phase	Trials
Completed	90
Recruiting	31
Terminated	24

Clinical Trial Sponsors for Nilotinib Hydrochloride

Sponsor Name

Sponsor Name for Nilotinib Hydrochloride
Sponsor	Trials
Novartis Pharmaceuticals	70
Novartis	20
National Cancer Institute (NCI)	16

Sponsor Type

Sponsor Type for Nilotinib Hydrochloride
Sponsor	Trials
Other	182
Industry	130
NIH	17

Nilotinib Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Nilotinib hydrochloride, a tyrosine kinase inhibitor, has been primarily used in the treatment of certain types of chronic myeloid leukemia (CML). However, recent clinical trials and market analyses indicate its potential in other therapeutic areas, including Parkinson's disease and advanced cancers. Here, we delve into the latest updates on clinical trials, market analysis, and projections for nilotinib hydrochloride.

Clinical Trials in Parkinson's Disease

Phase 2 Trial Overview

A significant clinical trial evaluating the safety and efficacy of nilotinib hydrochloride in patients with Parkinson's disease (PD) has provided promising results. This phase 2, randomized, double-blind, placebo-controlled trial involved 75 patients with moderately severe PD, who were randomized into three groups: placebo, nilotinib 150 mg, and nilotinib 300 mg[1].

Safety and Tolerability

The trial found that nilotinib hydrochloride at doses of 150 mg and 300 mg was reasonably safe and tolerable. However, there was a significant difference in the total number of serious adverse events (SAEs) among the treatment groups, with the 300 mg group experiencing the highest number of SAEs, including cardiovascular events[1].

Biomarker and Clinical Outcomes

The trial also explored the effects of nilotinib on cerebrospinal fluid (CSF) biomarkers, including brain dopamine turnover, oligomeric α-synuclein, and hyperphosphorylated tau. The results indicated that nilotinib altered these biomarkers, suggesting potential disease-modifying effects in PD[1].

Clinical Trials in Advanced Cancers

ComboMATCH Precision Medicine Initiative

Nilotinib hydrochloride is being investigated in combination with paclitaxel chemotherapy for the treatment of advanced cancers that have progressed despite taxane-based chemotherapy. The ECOG-ACRIN Cancer Research Group has initiated the EAY191-E4 trial as part of the ComboMATCH precision medicine initiative. This trial aims to evaluate whether nilotinib enhances the efficacy of paclitaxel and reduces neuropathy associated with chemotherapy[3].

Pre-Clinical and Phase 1 Data

Pre-clinical studies and a phase 1 clinical trial have shown that the combination of nilotinib and paclitaxel may be more effective than either drug alone, with reduced peripheral neuropathy. The EAY191-E4 trial will further assess this combination in a larger patient population[3].

Market Analysis

Global Market Size and Growth

The global nilotinib hydrochloride market is anticipated to grow significantly over the next few years. According to recent market research reports, the market is expected to reach a substantial value by 2028, driven by a compound annual growth rate (CAGR) of several percent from 2023 to 2028[2][5].

Market Segmentation

The market is segmented by major vendors, types, applications, and geography. Key players in the nilotinib hydrochloride market include Teva API, Dr. Reddy's, Aarti Pharmalabs, and Suzhou Lixin Pharmaceutical. The market segmentation helps in identifying real opportunities and understanding the competitive landscape[2][5].

Production and Consumption

The production and consumption of nilotinib hydrochloride are analyzed by region, providing insights into the global supply chain and demand patterns. This analysis is crucial for market players to evaluate their business approaches and strategies[2].

Projections and Future Outlook

Therapeutic Expansion

The potential therapeutic expansion of nilotinib hydrochloride into Parkinson's disease and advanced cancers is expected to drive market growth. Successful outcomes from ongoing and future clinical trials could lead to new indications and increased market share[1][3].

Market Trends

The post-COVID-19 impact on the market is a key consideration, with market players needing to adapt their business approaches to the new landscape. The report provides insights on market trends, including production methods, cost structure analysis, and regional trade balances, which are essential for strategic planning[2].

Key Takeaways

• Clinical Trials: Nilotinib hydrochloride shows promise in treating Parkinson's disease and advanced cancers, with ongoing trials evaluating its safety, efficacy, and potential disease-modifying effects.
• Market Growth: The global nilotinib hydrochloride market is expected to grow significantly, driven by new therapeutic applications and a strong CAGR.
• Market Players: Key players such as Teva API, Dr. Reddy's, and Aarti Pharmalabs are significant in the market, with regional production and consumption patterns influencing market dynamics.
• Future Outlook: Successful clinical trials and therapeutic expansions are likely to drive market growth and increase the drug's market share.

FAQs

What are the primary therapeutic areas for nilotinib hydrochloride?

Nilotinib hydrochloride is primarily used in the treatment of certain types of chronic myeloid leukemia (CML). However, it is being investigated for use in Parkinson's disease and advanced cancers.

What are the key findings from the phase 2 trial in Parkinson's disease?

The phase 2 trial found that nilotinib hydrochloride was reasonably safe and tolerable, altered exploratory CSF biomarkers, and showed potential disease-modifying effects in PD.

How does the combination of nilotinib and paclitaxel work in cancer treatment?

The combination aims to enhance the efficacy of paclitaxel by inhibiting proteins that block paclitaxel's action, potentially reducing cancer cell multiplication and neuropathy associated with chemotherapy.

Who are the main players in the global nilotinib hydrochloride market?

Key players include Teva API, Dr. Reddy's, Aarti Pharmalabs, and Suzhou Lixin Pharmaceutical.

What is the projected growth of the global nilotinib hydrochloride market?

The market is expected to reach a substantial value by 2028, driven by a significant CAGR from 2023 to 2028.

Sources

1. Nilotinib Effects on Safety, Tolerability, and Potential Biomarkers in Parkinson Disease - JAMA Neurology, 2019.
2. Global Nilotinib Hydrochloride Market | Size, Share, Price, import, export - 24 Chemical Research.
3. ECOG-ACRIN adds a new treatment trial to the ComboMATCH precision medicine initiative - ECOG-ACRIN.
4. Nilotinib Hydrochloride - Drug Targets, Indications, Patents - Synapse.
5. Global Nilotinib Hydrochloride Market Research - Valuates Reports.