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Nilotinib

Generic Name
Nilotinib
Brand Names
Tasigna, Nilotinib Accord
Drug Type
Small Molecule
Chemical Formula
C28H22F3N7O
CAS Number
641571-10-0
Unique Ingredient Identifier
F41401512X
Background

Nilotinib, also known as AMN107, is a tyrosine kinase inhibitor under investigation as a possible treatment for chronic myelogenous leukemia (CML). A Phase I clinical trial in 2006 showed that this drug was relatively safe and offered significant therapeutic benefits in cases of CML which were found to be resistant to treatment with imatinib (Gleevec), another tyrosine kinase inhibitor used as a first-line treatment for CML.

Indication

For the potential treatment of various leukemias, including chronic myeloid leukemia (CML).

Associated Conditions
Accelerated Phase Chronic Myelogenous Leukemia (CML), Chronic Phase Chronic Myeloid Leukemia, Newly diagnosed, chronic phase Chronic myeloid leukemia, Refractory Gastrointestinal stromal tumor
Clinical Trials
Related News

PEARL Study: PotEntial of Asciminib in the eaRly Treatment of CML

Phase 2
Not yet recruiting
Conditions
CML, Chronic Phase
Chronic Myeloid Leukemia, BCR/ABL-Positive
Chronic Myeloid Leukemia, Chronic Phase
Chronic Myeloid Leukemia
Interventions
First Posted Date
2024-05-10
Last Posted Date
2025-04-08
Lead Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
Target Recruit Count
160
Registration Number
NCT06409936

Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial

Phase 2
Recruiting
Conditions
Advanced Malignant Solid Neoplasm
Anatomic Stage III Breast Cancer AJCC v8
Anatomic Stage IV Breast Cancer AJCC v8
Locally Advanced Malignant Solid Neoplasm
Malignant Female Reproductive System Neoplasm
Metastatic HER2-Negative Breast Carcinoma
Metastatic Malignant Solid Neoplasm
Recurrent Endometrial Carcinoma
Recurrent Fallopian Tube Carcinoma
Recurrent Malignant Female Reproductive System Neoplasm
Interventions
Procedure: Biopsy Procedure
Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration
Procedure: Bone Scan
Procedure: Computed Tomography
Procedure: Echocardiography Test
Procedure: Magnetic Resonance Imaging
Procedure: Mutation Carrier Screening
Procedure: Positron Emission Tomography
Procedure: Multigated Acquisition Scan
First Posted Date
2022-10-03
Last Posted Date
2025-05-21
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
2900
Registration Number
NCT05564377
Locations
🇺🇸

University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States

🇺🇸

University of South Alabama Mitchell Cancer Institute, Mobile, Alabama, United States

🇺🇸

Alaska Women's Cancer Care, Anchorage, Alaska, United States

and more 443 locations

Testing the Use of Nilotinib and Paclitaxel as a Treatment for Patients With Prior Taxane Treatment, A ComboMATCH Treatment Trial

Phase 2
Active, not recruiting
Conditions
Metastatic Malignant Solid Neoplasm
Refractory Malignant Solid Neoplasm
Interventions
Procedure: Biopsy Procedure
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
First Posted Date
2022-09-26
Last Posted Date
2025-04-15
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
40
Registration Number
NCT05554341
Locations
🇺🇸

Carle at The Riverfront, Danville, Illinois, United States

🇺🇸

Cancer Care Specialists of Illinois - Decatur, Decatur, Illinois, United States

🇺🇸

Decatur Memorial Hospital, Decatur, Illinois, United States

and more 123 locations

A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in Adult Participants (≥18 Years of Age) With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP)

Phase 3
Active, not recruiting
Conditions
Philadelphia Chromosome-Positive Chronic Myeloid Leukemia
Interventions
First Posted Date
2022-07-13
Last Posted Date
2025-04-10
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
568
Registration Number
NCT05456191
Locations
🇺🇸

Rocky Mountain Cancer Centers, Boulder, Colorado, United States

🇺🇸

Illinois Cancer Care, Peoria, Illinois, United States

🇺🇸

Regions Hospital, Saint Paul, Minnesota, United States

and more 7 locations

Study to Evaluate Chronic Myeloid Leukemia Treatment Landscape and Real-life Treatment Outcomes in Hungary: Analysis of National Health Insurance Fund Database

Completed
Conditions
Chronic Myeloid Leukaemia
First Posted Date
2022-03-18
Last Posted Date
2023-10-27
Lead Sponsor
Pfizer
Target Recruit Count
1484
Registration Number
NCT05286528
Locations
🇭🇺

Pfizer, Budapest, Hungary

Study of Intravenous and Intraperitoneal Paclitaxel and Oral Nilotinib for Peritoneal Carcinomatosis From Colorectal, Appendiceal, Small Bowel, Gastric, Cholangiocarcinoma, Breast, Ovarian, or Other Gynecologic Primary Cancer

Phase 2
Active, not recruiting
Conditions
Gynecologic Cancer
Gynecologic Neoplasms
Peritoneal Carcinomatosis
Peritoneal Neoplasms
Ovarian Cancer
Ovarian Neoplasms
Colorectal Cancer
Colorectal Neoplasms
Appendiceal Cancer
Appendiceal Neoplasms
Interventions
First Posted Date
2022-01-11
Last Posted Date
2025-03-07
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
19
Registration Number
NCT05185947
Locations
🇺🇸

National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Evaluating the Efficacy and Safety of Nilotinib BE in Subjects With Early Alzheimer's Disease

Phase 3
Not yet recruiting
Conditions
Alzheimer Disease
Interventions
Drug: Placebo
First Posted Date
2021-12-03
Last Posted Date
2021-12-03
Lead Sponsor
KeifeRx, LLC
Target Recruit Count
1275
Registration Number
NCT05143528

A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP

Phase 3
Active, not recruiting
Conditions
Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive
Interventions
First Posted Date
2021-07-21
Last Posted Date
2025-04-18
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
406
Registration Number
NCT04971226
Locations
🇺🇸

Rocky Mountain Cancer Centers, Longmont, Colorado, United States

🇺🇸

Florida Cancer Specialists, Fort Myers, Florida, United States

🇺🇸

Florida Cancer Specialists Pan, Tallahassee, Florida, United States

and more 10 locations

Nilotinib Plus Dabrafenib/Trametinib or Encorafenib/Binimetinib in Metastatic Melanoma

First Posted Date
2021-05-26
Last Posted Date
2025-03-07
Lead Sponsor
Ruta Arays
Target Recruit Count
30
Registration Number
NCT04903119
Locations
🇺🇸

Markey Cancer Center, Lexington, Kentucky, United States

🇺🇸

St. Luke's University Health Network, Easton, Pennsylvania, United States

🇺🇸

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

Asciminib Roll-over Study

Phase 4
Recruiting
Conditions
Chronic Myelogenous Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Interventions
First Posted Date
2021-05-07
Last Posted Date
2025-05-21
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
347
Registration Number
NCT04877522
Locations
🇺🇸

Michigan Med University of Michigan, Ann Arbor, Michigan, United States

🇺🇸

Memorial Sloan Kettering, New York, New York, United States

🇺🇸

Oregon Health Sciences University, Portland, Oregon, United States

and more 2 locations
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