MedPath

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

Predictive Biomarkers of Biological Activity and Efficacy of Nilotinib on ZAK Target in Non-metastatic Colon Cancer

Early Phase 1
Withdrawn
Conditions
Colon Cancer
Interventions
First Posted Date
2016-05-17
Last Posted Date
2017-10-06
Lead Sponsor
Institut Bergonié
Registration Number
NCT02774512
Locations
🇫🇷

Institut Bergonié, Bordeaux, France

Metabolic Outcomes in Patients Receiving Tyrosine Kinase Inhibitor (TKI) Therapy With Dasatinib or Nilotinib

Completed
Conditions
Chronic Myeloid Leukemia (CML)
Interventions
First Posted Date
2016-04-11
Last Posted Date
2016-04-11
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
2650
Registration Number
NCT02733445

Dasatinib or Nilotinib Followed by Imatinib in Patients With Newly Diagnosed, Chronic Phase Chronic Myeloid Leukemia

Phase 2
Terminated
Conditions
Leukemia
Chronic Myeloid Leukemia
Chronic Myelogenous Leukemia
Interventions
First Posted Date
2016-03-15
Last Posted Date
2018-11-02
Lead Sponsor
Emory University
Target Recruit Count
7
Registration Number
NCT02709083
Locations
🇺🇸

Emory University/Winship Cancer Institute, Atlanta, Georgia, United States

A Study Comparing Ponatinib and Nilotinib in Participants With Chronic Myeloid Leukemia

Phase 3
Terminated
Conditions
Chronic Phase Chronic Myeloid Leukemia
Interventions
First Posted Date
2015-12-11
Last Posted Date
2021-11-26
Lead Sponsor
Ariad Pharmaceuticals
Target Recruit Count
44
Registration Number
NCT02627677
Locations
🇧🇪

Cliniques Universitaire Saint-Luc (Site 058), Bruxelles, Belgium

A Phase III Randomized Trial of the Reduction of Chemotherapy in Philadelphia Chromosome-positive ALL of Young Adults

Phase 3
Recruiting
Conditions
Philadelphia Chromosome Positive Adult Acute Lymphoblastic Leukemia
Interventions
Drug: Aracytine (Ara C)
Drug: Granulocyte Colony-Stimulating Factor (G-CSF)
Drug: Depomedrol
First Posted Date
2015-11-20
Last Posted Date
2019-10-21
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Target Recruit Count
265
Registration Number
NCT02611492
Locations
🇫🇷

Hopital Saint Louis, Paris, France

Sustained Treatment-free Remission in BCR-ABL+ Chronic Myeloid Leukemia

Phase 4
Conditions
Chronyc Myeloid Leukemia
Interventions
First Posted Date
2015-11-11
Last Posted Date
2022-01-20
Lead Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
Target Recruit Count
450
Registration Number
NCT02602314
Locations
🇮🇹

S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo, Alessandria, Italy

🇮🇹

UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro, Bari, Italy

🇮🇹

Ausl Della Romagna, Ospedale "Infermi" - Rimini - Uo Ematologia, Rimini, Italy

and more 79 locations

Study Assessing Deep Molecular Response in Adult Patients With CML in Chronic Phase Treated With Nilotinib Firstline.

Phase 4
Completed
Conditions
Chronic Myeloid Leukemia
Interventions
First Posted Date
2015-09-11
Last Posted Date
2022-07-22
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
171
Registration Number
NCT02546674
Locations
🇩🇪

Novartis Investigative Site, Wuerzburg, Germany

Multicenter, PhaseⅣ, Open Label Trial of Nilotinib in Adult Patients Diagnosed Philadelphia Chromosome Positive(Ph+) Chronic Myeloid Leukemia in CP/AP Intolerant to Dasatinib

Phase 4
Conditions
Leukemia, Chronic Myeloid
Interventions
First Posted Date
2015-03-17
Last Posted Date
2015-03-17
Lead Sponsor
Samsung Medical Center
Target Recruit Count
40
Registration Number
NCT02389920

Combination Nilotinib and Paclitaxel in Adults With Relapsed Solid Tumors

Phase 1
Recruiting
Conditions
Solid Tumors
Interventions
First Posted Date
2015-03-05
Last Posted Date
2025-05-11
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
70
Registration Number
NCT02379416
Locations
🇺🇸

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

Stem Cell Monitoring for CML Patients Undergoing Nilotinib Therapy

Phase 2
Completed
Conditions
Chronic Myeloid Leukemia
Interventions
First Posted Date
2015-02-03
Last Posted Date
2022-03-25
Lead Sponsor
Weill Medical College of Cornell University
Target Recruit Count
16
Registration Number
NCT02353728
Locations
🇺🇸

Weill Cornell Medical College, New York, New York, United States

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy