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), anoth...

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
Associated Therapies
-

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

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
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

Stem Cell Monitoring for CML Patients Undergoing Nilotinib Therapy

Phase 2
Completed
Conditions
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

Optimization of TKIs Treatment and Quality of Life in Ph+ CML Patients ≥60 Years in Deep Molecular Response

First Posted Date
2014-12-29
Last Posted Date
2024-08-13
Lead Sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Target Recruit Count
229
Registration Number
NCT02326311
Locations
🇮🇹

Policlinico Universitario di Milano, Milano, Italy

Nilotinib in Cognitively Impaired Parkinson Disease Patients 001

First Posted Date
2014-11-02
Last Posted Date
2015-12-16
Lead Sponsor
Georgetown University
Target Recruit Count
12
Registration Number
NCT02281474
Locations
🇺🇸

MedStar Georgetown University Hospital, Washington, District of Columbia, United States

A Study of Imatinib and Nilotinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase

Phase 3
Completed
Conditions
Interventions
First Posted Date
2014-10-23
Last Posted Date
2019-08-19
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
225
Registration Number
NCT02272777
Locations
🇨🇳

Novartis Investigative Site, Shanghai, China

Safety and Tolerability of Combined Treatment With Nilotinib and Ruxolitinib in CML and Ph+ ALL Patients

Phase 1
Completed
Conditions
Interventions
First Posted Date
2014-10-01
Last Posted Date
2019-05-01
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
5
Registration Number
NCT02253277
Locations
🇩🇪

Novartis Investigative Site, Leipzig, Germany

An Open-Label, Phase I/II Study of Nilotinib (Tasigna) and MEK-162 (ARRY-162) Used in Combination for Patients With Refractory or Advanced Chronic Myeloid Leukemia and Philadelphia Positive Acute Leukemia (Protocol CAMN107AUS41T)

First Posted Date
2014-08-26
Last Posted Date
2020-02-12
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
1
Registration Number
NCT02225574
Locations
🇺🇸

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

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