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
-
Clinical Trials
Related News

Study of Molecular Response in Adult Patients on Nilotinib With Philadelphia Chromosome Positive Chronic Myelogenous Leukemia (Ph+ CML) in Chronic Phase and a Suboptimal Molecular Response to Imatinib

Phase 2
Terminated
Conditions
Chronic Myelogenous Leukemia - Chronic Phase
Interventions
Drug: Nilotinib
First Posted Date
2008-03-27
Last Posted Date
2021-08-18
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
18
Registration Number
NCT00644878
Locations
🇺🇸

USC Norris Cancer Center Jane Anne Nohl, Los Angeles, California, United States

🇺🇸

St. Agnes Hospital, Baltimore, Maryland, United States

🇺🇸

South Texas Institute of Cancer, Corpus Christi, Texas, United States

and more 8 locations

Nilotinib as First-line Treatment of Ph+ CML in Early Chronic Phase

Phase 2
Completed
Conditions
Chronic Myeloid Leukemia
First Posted Date
2007-06-01
Last Posted Date
2022-01-18
Lead Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
Target Recruit Count
74
Registration Number
NCT00481052
Locations
🇮🇹

Unità Operativa Ematologica - Università degli Studi di Bari, Bari, Italy

🇮🇹

Sezione di Ematologia e Trapianti Spedali Civili, Brescia, Italy

🇮🇹

Ospedale Ferrarotto, Catania, Italy

and more 19 locations

A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

Phase 3
Completed
Conditions
Myelogenous Leukemia, Chronic
Interventions
Drug: nilotinib
Drug: imatinib
First Posted Date
2007-05-10
Last Posted Date
2020-11-18
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
846
Registration Number
NCT00471497
Locations
🇺🇸

University of California at Los Angeles Dept. of Hematology Clinic, Los Angeles, California, United States

🇺🇸

Kaiser Permanente - California Northern Kaiser Med, Vallejo, California, United States

🇺🇸

Florida Cancer Specialists Dept. FloridaCancerSpecialists, Fort Myers, Florida, United States

and more 29 locations

Efficacy and Safety of Nilotinib (AMN107) Compared With Current Treatment Options in Patients With GIST Who Have Failed Both Imatinib and Sunitinib

First Posted Date
2007-05-09
Last Posted Date
2012-06-12
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
248
Registration Number
NCT00471328
Locations
🇺🇸

Washington University School of Medicine - Siteman Cancer Center, St. Louis, Missouri, United States

🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

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

and more 10 locations

Pharmacokinetics of Nilotinib in Subjects With Impaired Hepatic Function and Healthy Subjects With Normal Hepatic Function

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: Nilotinib
First Posted Date
2007-01-05
Last Posted Date
2012-03-08
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
27
Registration Number
NCT00418626

Bioavailability Study Comparing Two New Nilotinib Tablet Formulations to an Established Nilotinib Capsule Formulation in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: Nilotinib
First Posted Date
2007-01-05
Last Posted Date
2020-12-09
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
24
Registration Number
NCT00418769

Effects of Rifampin on the Pharmacokinetics of Nilotinib in Healthy Subjects

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: Nilotinib
First Posted Date
2007-01-05
Last Posted Date
2010-03-19
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
12
Registration Number
NCT00418756

Oral Nilotinib in Adults With Chronic Myeloid Leukemia (CML) in Blast Crisis Who Are Imatinib Resistant or Intolerant

First Posted Date
2006-12-19
Last Posted Date
2011-07-13
Lead Sponsor
Novartis Pharmaceuticals
Registration Number
NCT00413270
Locations
🇨🇦

Novartis Investigative Site, Quebec, Canada

A Phase l/ll Study of AMN107 in Adult Patients With Glivec-intolerant CML or Relapsed-refractory Ph+ALL

First Posted Date
2006-10-06
Last Posted Date
2020-12-08
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
42
Registration Number
NCT00384228
Locations
🇯🇵

Novartis Investigative Site, Tokyo, Japan

Phase II Nilotinib With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML)

Phase 2
Completed
Conditions
Leukemia, Myelogenous, Chronic
Interventions
Drug: Nilotinib
First Posted Date
2005-08-12
Last Posted Date
2019-09-24
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
148
Registration Number
NCT00129740
Locations
🇺🇸

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

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