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
-

Efficacy, Safety, Tolerability and Pharmacokinetics (PK) of Nilotinib (AMN107) in Pulmonary Arterial Hypertension (PAH)

First Posted Date
2010-08-11
Last Posted Date
2014-05-01
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
23
Registration Number
NCT01179737
Locations
🇨🇭

Novartis Investigative Site, Zurich, Switzerland

Efficacy of Nilotinib in First or Second Line Treatment of Primary Melanomas Stage III Unresectable Melanomas.

First Posted Date
2010-07-22
Last Posted Date
2011-02-08
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Target Recruit Count
25
Registration Number
NCT01168050
Locations
🇫🇷

Hôpital Saint-Louis, Paris, France

Phase 1 Nilotinib in Steroid Dependent/Refractory Chronic Graft Versus Host Disease

First Posted Date
2010-07-02
Last Posted Date
2020-04-15
Lead Sponsor
Stanford University
Target Recruit Count
33
Registration Number
NCT01155817
Locations
🇨🇦

Gordon and Leslie Diamond Health Care Centre Hematology Administration, Vancouver, British Columbia, Canada

🇺🇸

Stanford University School of Medicine, Stanford, California, United States

🇺🇸

Roswell Park Cancer Institute, Buffalo, New York, United States

and more 2 locations

Study of Platelet Derived Growth Factor Receptor (PDGFR) in Recurrent Malignant Gliomas

Phase 2
Completed
Conditions
Interventions
First Posted Date
2010-06-09
Last Posted Date
2020-05-05
Lead Sponsor
David Piccioni, M.D., Ph.D
Target Recruit Count
38
Registration Number
NCT01140568
Locations
🇺🇸

The Rebecca and John Moores UCSD Cancer Center, La Jolla, California, United States

Study of Nilotinib in Ph+ CML-CP Patients With Low Imatinib Trough Plasma Concentrations

First Posted Date
2010-05-26
Last Posted Date
2021-05-20
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
3
Registration Number
NCT01131325
Locations
🇺🇸

Comprehensive Cancer Centers of Nevada CCC of Nevada (1), Las Vegas, Nevada, United States

🇺🇸

Cancer Center of the High Plains, Amarillo, Texas, United States

🇺🇸

Baylor Health Care System/Sammons Cancer Center Dept. of Sammons Cancer (2), Dallas, Texas, United States

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

Phase 3
Completed
Conditions
Interventions
First Posted Date
2010-05-20
Last Posted Date
2017-02-28
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
6
Registration Number
NCT01126892
Locations
🇻🇪

Banco Municipal de Sangre, Caracas, Venezuela

🇨🇴

Hospital San José, Bogotá, Colombia, Bogota, Colombia

Evaluation of Nilotinib In Patients With Advanced Gastrointestinal Stromal Tumor (GIST)

Phase 2
Completed
Conditions
Interventions
First Posted Date
2010-04-27
Last Posted Date
2017-02-28
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
2
Registration Number
NCT01110668
Locations
🇹🇷

Novartis Investigative Site, Izmir, Turkey

Study of Nilotinib in Metastatic Melanoma With KIT Aberrations

Phase 2
Completed
Conditions
Interventions
First Posted Date
2010-04-07
Last Posted Date
2015-12-29
Lead Sponsor
Samsung Medical Center
Target Recruit Count
33
Registration Number
NCT01099514
Locations
🇰🇷

Samsung Cancer Center, Seoul, Korea, Republic of

Trial of Tasigna (Nilotinib) 400 mg Twice Daily Alone or With Gleevec (Imatinib Mesylate) 400 mg Daily for Patients With Advanced Gastrointestinal Stromal Tumor (GIST)

First Posted Date
2010-03-18
Last Posted Date
2017-03-15
Lead Sponsor
Fox Chase Cancer Center
Target Recruit Count
5
Registration Number
NCT01089595
Locations
🇺🇸

Siteman Cancer Center, Washington University School of Mediciine, St Louis, Missouri, United States

🇺🇸

Wake Forest University, Winston-Salem, North Carolina, United States

🇺🇸

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

A Pharmacokinetic (PK) Study of Nilotinib in Pediatric Patients With Philadelphia Chromosome-positive (Ph+) Chronic Myelogenous Leukemia (CML) or Acute Lymphoblastic Leukemia (ALL)

First Posted Date
2010-03-01
Last Posted Date
2020-12-29
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
15
Registration Number
NCT01077544
Locations
🇬🇧

Novartis Investigative Site, Bristol, United Kingdom

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