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
Associated Therapies
-
Clinical Trials
Related News

Nilotinib in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase

Conditions
Chronic Myeloid Leukemia
First Posted Date
2009-05-20
Last Posted Date
2012-07-18
Lead Sponsor
Novartis Pharmaceuticals
Registration Number
NCT00905593
Locations
🇲🇽

Novartis Investigative Site, Mexico City, Mexico

Nilotinib With Chemotherapy for the Treatment of Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Phase 1
Terminated
Conditions
Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
Acute Lymphoblastic Leukemia
Interventions
Drug: Nilotinib
First Posted Date
2009-05-20
Last Posted Date
2015-07-09
Lead Sponsor
Rony Schaffel
Target Recruit Count
8
Registration Number
NCT00905398

Nilotinib in Treating Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia

Phase 2
Completed
Conditions
Leukemia
Interventions
Drug: nilotinib
Genetic: cytogenetic analysis
Genetic: mutation analysis
Genetic: polymerase chain reaction
Other: pharmacological study
First Posted Date
2008-12-17
Last Posted Date
2018-07-24
Lead Sponsor
Cancer Trials Ireland
Target Recruit Count
40
Registration Number
NCT00809211
Locations
🇩🇪

Universitätsklinikum Charité Berlin, Berlin, Germany

🇮🇪

St. James's Hospital, Dublin, Ireland

🇮🇪

University College Hospital, Galway, Ireland

and more 3 locations

Randomized Phase Lll Study of Imatinib Dose Optimization vs Nilotinib in CML Patients With Suboptimal Response to Imatinib

Phase 3
Completed
Conditions
Chronic Myelogenous Leukemia
Interventions
Drug: nilotinib
Drug: imatinib
First Posted Date
2008-12-05
Last Posted Date
2015-11-16
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
191
Registration Number
NCT00802841
Locations
🇻🇪

Novartis Investigative Site, Maracaibo, Estado Zulia, Venezuela

Nilotinib in TKI Resistant or Intolerant Patients With Metastatic Mucosal, Acral, or Chronically Sun Damaged Melanoma

Phase 2
Completed
Conditions
Mucosal Lentiginous Melanoma
Acral Melanoma
Melanoma
Interventions
Drug: Nilotinib
First Posted Date
2008-11-11
Last Posted Date
2018-11-15
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
20
Registration Number
NCT00788775
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

🇺🇸

The Angeles Clinic and Research Institute, Santa Monica, California, United States

and more 5 locations

Study of Treatment With Nilotinib in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase

Phase 4
Completed
Conditions
Chronic Myeloid Leukemia
Interventions
Drug: Nilotinib
First Posted Date
2008-11-06
Last Posted Date
2017-02-23
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
89
Registration Number
NCT00786812
Locations
🇧🇷

Novartis Investigative Site, São Paulo, SP, Brazil

Nilotinib in Advanced Gastrointestinal Stromal Tumors (GIST)

Phase 2
Terminated
Conditions
Gastrointestinal Stromal Tumors
First Posted Date
2008-10-31
Last Posted Date
2013-04-22
Lead Sponsor
Fox Chase Cancer Center
Target Recruit Count
13
Registration Number
NCT00782834
Locations
🇺🇸

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

Nilotinib and Imatinib Mesylate in Treating Patients With Early Chronic Phase Chronic Myelogenous Leukemia

Phase 2
Completed
Conditions
Leukemia
First Posted Date
2008-10-09
Last Posted Date
2022-01-04
Lead Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
Target Recruit Count
129
Registration Number
NCT00769327
Locations
🇮🇹

Centro Oncologico Basilicata, Rionero in Vulture, Potenza, Italy

🇮🇹

Unità di Oncoematologia Azienda Ospedaliera Garibaldi, Catania, Italy

🇮🇹

Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga, Orbassano, Italy

and more 34 locations

Combination of Nilotinib (AMN107) and RAD001 in Patients With Acute Myeloid Leukemia

Phase 1
Completed
Conditions
Acute Myeloid Leukemia
First Posted Date
2008-09-30
Last Posted Date
2012-08-08
Lead Sponsor
Technical University of Munich
Target Recruit Count
40
Registration Number
NCT00762632
Locations
🇩🇪

Medical faculty of the Technical University Munich, Munich, Bavaria, Germany

Nilotinib Versus Standard Imatinib (400/600 mg Every Day (QD)) Comparing the Kinetics of Complete Molecular Response for Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Pts With Evidence of Persistent Leukemia by Real-time Quantitative Polymerase Chain Reaction (RQ-PCR)

Phase 3
Completed
Conditions
CHRONIC MYELOGENOUS LEUKEMIA
Interventions
Drug: Nilotinib
Drug: Imatinib
First Posted Date
2008-09-26
Last Posted Date
2016-11-08
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
207
Registration Number
NCT00760877
Locations
🇪🇸

Novartis Investigative Site, Madrid, Spain

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