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
-

Nilotinib in Newly Diagnosed Adult Philadelphia Chromosome & /or BCR-ABL Positive Chronic Myeloid Leukaemia in Chronic Phase

Phase 4
Completed
Conditions
Interventions
First Posted Date
2010-02-02
Last Posted Date
2017-02-24
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
1090
Registration Number
NCT01061177
Locations
🇬🇧

Novartis Investigative Site, Oxford, United Kingdom

Study to Evaluate Nilotinib in Chronic Myelogenous Leukemia (CML) Patients With SubOptimal Response

First Posted Date
2010-01-07
Last Posted Date
2016-04-08
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
45
Registration Number
NCT01043874
Locations
🇯🇵

Novartis Investigative Site, Saga, Japan

A Study of AMNN107 in the Treatment of Metastatic and/or Inoperable Melanoma Harboring a c-Kit Mutation

Phase 2
Completed
Conditions
Interventions
First Posted Date
2009-12-09
Last Posted Date
2015-12-30
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
55
Registration Number
NCT01028222
Locations
🇺🇸

Baylor Health Care System/Sammons Cancer Center Baylor 2, Dallas, Texas, United States

🇺🇸

University of California San Diego - Moores Cancer Center UCSD Moores Cancer Center, La Jolla, California, United States

🇺🇸

Case Western Reserve Case Western, Cleveland, Ohio, United States

and more 12 locations

Ph+/Bcr-Abl+ ALL Imatinib and Nilotinib Rotational Study

Phase 2
Completed
Conditions
First Posted Date
2009-12-03
Last Posted Date
2022-10-12
Lead Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
Target Recruit Count
40
Registration Number
NCT01025505
Locations
🇮🇹

Osp. Reg. A. Di Summa, Brindisi, Italy

🇮🇹

Clinica Ematologica - Università degli Studi, Genova, Italy

🇮🇹

U.O. Ematologia, Azienda Ospedaliera Universitaria Senese, Siena, Italy

and more 32 locations

An Exploratory Trial to Assess the Improvement of Adverse Events in Chronic Myelogenous Leukemia Patients Treated With Imatinib When Switched to Nilotinib Treatment

Phase 4
Completed
Conditions
Interventions
First Posted Date
2009-09-18
Last Posted Date
2021-07-01
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
52
Registration Number
NCT00980018
Locations
🇺🇸

Presbyterian Hospital of Dallas TexasOncology@PresbyterianHosp, Dallas, Texas, United States

🇺🇸

Texas Oncology Texas Oncology - Sugar Land, Dallas, Texas, United States

🇺🇸

Rocky Mountain Cancer Centers RMCC - Aurora, Greenwood Village, Colorado, United States

and more 17 locations

Nilotinib Pharmacokinetics (PK) in Gastrointestinal Stromal Tumor (GIST): Nilotinib PK

Completed
Conditions
Interventions
First Posted Date
2009-09-14
Last Posted Date
2020-01-07
Lead Sponsor
Asan Medical Center
Target Recruit Count
17
Registration Number
NCT00976612
Locations
🇰🇷

Asan Medical Center, Seoul, Korea, Republic of

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

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

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

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
Interventions
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

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