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
-

Daunorubicin Hydrochloride, Cytarabine, and Nilotinib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

First Posted Date
2013-03-07
Last Posted Date
2023-05-31
Lead Sponsor
Mayo Clinic
Target Recruit Count
34
Registration Number
NCT01806571
Locations
🇺🇸

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

🇺🇸

Mayo Clinic, Rochester, Minnesota, United States

De- Escalation and Stopping Treatment of Imatinib, Nilotinib or sprYcel in Chronic Myeloid Leukaemia

First Posted Date
2013-03-05
Last Posted Date
2017-05-04
Lead Sponsor
University of Liverpool
Target Recruit Count
168
Registration Number
NCT01804985
Locations
🇬🇧

University of Liveprool, Liverpool, United Kingdom

Multicenter Single-arm Pilot Study Evaluating Efficacy of Nilotinib in CML Patients With Molecular Relapse After Glivec Discontinuation Within the Context of the STIM Trials (STIM and STIM2)

First Posted Date
2013-01-24
Last Posted Date
2022-08-18
Lead Sponsor
University Hospital, Bordeaux
Target Recruit Count
31
Registration Number
NCT01774630
Locations
🇫🇷

Centre Hospitalier Lyon Sud, Service Hématologie, Pierre Benite, France

🇫🇷

CHU de Toulouse, Service d'Hématologie, Toulouse, France

🇫🇷

Centre Hospitalier de Versailles - Hôpital André Mignot - Service de Médecine B, Le Chesnay, France

and more 7 locations

A Study That Switched Patients From Imatinib to Nilotinib and Then Was Followed by Treatment Cessation

Phase 2
Completed
Conditions
Interventions
First Posted Date
2012-12-07
Last Posted Date
2020-03-10
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
59
Registration Number
NCT01744665
Locations
🇺🇸

Compassionate Care Research Group Inc CCCMG, Fountain Valley, California, United States

🇺🇸

Michigan State University / Breslin Cancer Center Breslin Cancer Center (3), Lansing, Michigan, United States

🇺🇸

Hackensack University Medical Center John Theurer Cancer Center, Hackensack, New Jersey, United States

and more 51 locations

A Randomized Phase III Study to Assess the Effect of a Longer Duration of Consolidation Treatment With Nilotinib on TFR in CP CML.

First Posted Date
2012-12-06
Last Posted Date
2021-07-15
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
620
Registration Number
NCT01743989
Locations
🇬🇧

Novartis Investigative Site, London, United Kingdom

Study to Allow Access to Nilotinib for Patients Who Are on Nilotinib Treatment in a Novartis-sponsored Study

First Posted Date
2012-11-28
Last Posted Date
2024-02-08
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
57
Registration Number
NCT01735955
Locations
🇬🇧

Novartis Investigative Site, Newcastle upon Tyne, United Kingdom

Ruxolitinib in Combination With Nilotinib in Chronic Myeloid Leukemia (CML) Patients

First Posted Date
2012-10-05
Last Posted Date
2021-01-05
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Target Recruit Count
11
Registration Number
NCT01702064
Locations
🇺🇸

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

Treatment-free Remission After Achieving Sustained MR4.5 on Nilotinib (ENESTop)

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2012-10-03
Last Posted Date
2024-11-15
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
163
Registration Number
NCT01698905
Locations
🇺🇸

USC Kenneth Norris Comprehensive Cancer Center, Los Angeles, California, United States

🇺🇸

Indiana Blood and Marrow Institute, Beech Grove, Indiana, United States

🇺🇸

St Agnes Hospital, Baltimore, Maryland, United States

and more 3 locations
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