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
Clinical Trials
Related News

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
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
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

A Study of Nilotinib Versus Imatinib in GIST Patients

Phase 3
Completed
Conditions
Gastrointestinal Stromal Tumor (GIST)
Interventions
First Posted Date
2008-11-05
Last Posted Date
2016-06-16
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
644
Registration Number
NCT00785785
Locations
🇻🇪

Novartis Investigative Site, Caracas, Distrito Capital, Venezuela

🇺🇸

Birmingham Hematology and Oncology Associates, Birmingham, Alabama, United States

🇺🇸

Ocala Oncology Center Dept. of Ocala Oncology Center, Ocala, Florida, United States

and more 26 locations

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
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

Treatment of Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumors in First Line With Nilotinib

Phase 4
Completed
Conditions
Gastrointestinal Stromal Tumors
Interventions
First Posted Date
2008-09-22
Last Posted Date
2025-02-18
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
34
Registration Number
NCT00756509
Locations
🇮🇹

Novartis Investigative Site, Milano, MI, Italy

Nilotinib 800 Mg And Imatinib 800 Mg For The Treatment Of Patients With Gastrointestinal Stromal Tumors (Gist) Refractory To Imatinib 400 Mg

Phase 3
Terminated
Conditions
Gastrointestinal Stromal Tumors
Interventions
First Posted Date
2008-09-11
Last Posted Date
2014-03-26
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
94
Registration Number
NCT00751036
Locations
🇻🇪

Novartis Investigative Site, Caracas, Distrito Capital, Venezuela

Nilotinib Pre and Post Allogeneic Stem Cell Transplantation

Phase 2
Completed
Conditions
Chronic Myeloid Leukemia
Acute Lymphoblastic Leukemia
Stem Cell Transplantation
Interventions
First Posted Date
2008-09-10
Last Posted Date
2016-04-20
Lead Sponsor
Sheba Medical Center
Target Recruit Count
24
Registration Number
NCT00750659
Locations
🇮🇱

Chaim Sheba Medical Center, Tel-Hashomer, Israel

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