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
-

TKI and Interferon Alpha Evaluation Initiated by the German Chronic Myeloid Leukemia Study Group - the TIGER Study

First Posted Date
2012-08-06
Last Posted Date
2023-05-10
Lead Sponsor
University of Jena
Target Recruit Count
717
Registration Number
NCT01657604
Locations
🇩🇪

Universitätsklinikum Aachen Medizinische Klinik IV, Aachen, Germany

🇩🇪

Evangelisches Klinikum Bethel, Bielefeld, Germany

🇩🇪

DIAKO Ev. Diakonie-Krankenhaus gGmbH, Medizinische Klinik II, Bremen, Germany

and more 108 locations

Prospective Investigation of Dynamics of ABL Mutations in Imatinib Failed CML Patients Treated With Nilotinib

First Posted Date
2012-03-26
Last Posted Date
2014-01-13
Lead Sponsor
Seoul St. Mary's Hospital
Target Recruit Count
125
Registration Number
NCT01562847
Locations
🇰🇷

Seoul St. Mary's Hospital, Seoul, Korea, Republic of

Nilotinib in PH+, BCR-, ABL+ CML Patients

Phase 3
Completed
Conditions
First Posted Date
2012-02-17
Last Posted Date
2018-08-06
Lead Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
Target Recruit Count
109
Registration Number
NCT01535391
Locations
🇮🇹

Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi, Bologna, Italy

🇮🇹

Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto", Catania, Italy

🇮🇹

USD Trapianti di midollo per adulti - Cattedra di Ematologia - Università degli Studi di Brescia, Brescia, Italy

and more 31 locations

Evaluation of Efficacy and Safety of Nilotinib in Combination With Chemotherapy in Elderly Patients With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

First Posted Date
2012-02-07
Last Posted Date
2020-07-30
Lead Sponsor
Goethe University
Target Recruit Count
79
Registration Number
NCT01528085
Locations
🇫🇷

CHU de La Réunion - Hôpital Félix Guyon, SAINT DENIS Cedex, France

🇫🇷

CHRU de Strasbourg - Hôpital Hautepierre, STRASBOURG Cedex, France

🇫🇷

HIA Sainte Anne, TOULON Cedex 9, France

and more 66 locations

Nilotinib With Radiation for High Risk Chordoma

Phase 1
Active, not recruiting
Conditions
Interventions
First Posted Date
2011-08-02
Last Posted Date
2024-03-12
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
29
Registration Number
NCT01407198
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

A Trial Looking at Nilotinib to Treat Acral and Mucosal Melanoma Skin Cancer That Has Spread

First Posted Date
2011-07-15
Last Posted Date
2017-06-08
Lead Sponsor
Institute of Cancer Research, United Kingdom
Target Recruit Count
29
Registration Number
NCT01395121
Locations
🇬🇧

Royal Marsden NHS Foundation Trust, London, United Kingdom

Study of Oral AMN107 (Nilotinib) in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase Previously Enrolled to CAMN107A2109 Trial

Phase 4
Completed
Conditions
Interventions
First Posted Date
2011-06-08
Last Posted Date
2016-11-16
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
19
Registration Number
NCT01368523
Locations
🇵🇱

Novartis Investigative Site, Warsaw, Poland

Gleevec as Maintenance Therapy After Cytogenetic Response With Nilotinib in Newly Diagnosed Chronic Myelogenous Leukemia

Not Applicable
Recruiting
Conditions
Interventions
First Posted Date
2011-03-16
Last Posted Date
2024-01-31
Lead Sponsor
American University of Beirut Medical Center
Target Recruit Count
25
Registration Number
NCT01316250
Locations
🇱🇧

American University of Beirut Medical Center, Beirut, Lebanon

Efficacy of Nilotinib in Adult Patients With Gastrointestinal Stromal Tumors Resistant to Imatinib and Sunitinib.

Phase 3
Completed
Conditions
Interventions
First Posted Date
2011-02-03
Last Posted Date
2017-01-02
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
125
Registration Number
NCT01289028
Locations
🇮🇹

Novartis Investigative Site, Torino, TO, Italy

Study to Evaluate Nilotinib in Adult Patients With Imatinib-resistant or Imatinib-intolerant Chronic Myelogenous Leukemia (CML), or Relapse/Refractory Ph+ Acute Lymphoblastic Leukemia (ALL) (Extension Study)

First Posted Date
2011-01-19
Last Posted Date
2020-12-08
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
42
Registration Number
NCT01279473
Locations
🇯🇵

Novartis Investigative Site, Aichi, Japan

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