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
Associated Therapies
-
Clinical Trials
Related News

Safety and Efficacy of Nilotinib vs. Imatinib in the Treatment of Newly Diagnosed Chinese Ph+ CML-CP Patients

Phase 3
Completed
Conditions
Chronic Myeloid Leukemia
Interventions
Drug: Imatinib
Drug: Nilotinib
First Posted Date
2011-01-12
Last Posted Date
2016-04-08
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
267
Registration Number
NCT01275196
Locations
🇨🇳

Novartis Investigative Site, Shanghai, China

Study of Nilotinib as First Line Treatment in Philadelphia Chromosome Positive(Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

Phase 2
Completed
Conditions
Chronic Myelogenous Leukemia
Interventions
Drug: Nilotinib
First Posted Date
2011-01-11
Last Posted Date
2020-09-01
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
112
Registration Number
NCT01274351
Locations
🇹🇷

Novartis Investigative Site, Trabzon, Turkey

Tasigna Neoadjuvant Gastrointestinal Stromal Tumor (GIST)

Phase 2
Withdrawn
Conditions
Gastrointestinal Cancer
Interventions
Drug: Nilotinib
First Posted Date
2011-01-05
Last Posted Date
2012-08-02
Lead Sponsor
M.D. Anderson Cancer Center
Registration Number
NCT01270893

Safety and Efficacy of Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia Patients

Phase 3
Completed
Conditions
Chronic Myeloid Leukemia
Interventions
Drug: Nilotinib
First Posted Date
2010-12-06
Last Posted Date
2016-03-03
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
421
Registration Number
NCT01254188
Locations
🇦🇪

Novartis Investigative Site, Dubai, United Arab Emirates

Nilotinib for Cytomegalovirus Prophylaxis and Treatment After Allogeneic Hematopoietic Stem Cell Transplantation

Phase 2
Completed
Conditions
Patients Who Have Received Allo-HSCT
Interventions
Drug: nilotinib
First Posted Date
2010-12-02
Last Posted Date
2018-09-12
Lead Sponsor
National Taiwan University Hospital
Target Recruit Count
36
Registration Number
NCT01252017
Locations
🇨🇳

National Taiwan University Hospital, Taipei, Taiwan

CMR Rate of Newly Diagnosed CML-CP Patients Treated With Nilotinib

First Posted Date
2010-10-25
Last Posted Date
2016-02-08
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
128
Registration Number
NCT01227577
Locations
🇺🇸

Hackensack University Medical Center Dept.of HackensackUniv.MedCtr., Hackensack, New Jersey, United States

🇺🇸

Advanced Medical Specialties, Miami, Florida, United States

🇺🇸

Louis A. Weiss Memorial Hospital, Chicago, Illinois, United States

and more 29 locations

Safety and Efficacy Study of Nilotinib Combined With Mitoxantrone, Etoposide, and High-dose Cytarabine Induction Chemotherapy Followed by Consolidation for Patients With C-kit Positive Acute Myeloid Leukemia

Phase 1
Terminated
Conditions
Acute Myeloid Leukemia
Interventions
Drug: NOVE-HiDAC
Drug: Nilotinib
First Posted Date
2010-10-18
Last Posted Date
2015-06-22
Lead Sponsor
University Health Network, Toronto
Target Recruit Count
12
Registration Number
NCT01222143
Locations
🇨🇦

Princess Margaret Hospital, Toronto, Ontario, Canada

Nilotinib in Patients With Relapsed or Metastatic Pigmented Villonodular Synovitis/Tenosynovial Giant Cell Tumor/Diffuse-Type Giant Cell Tumor

First Posted Date
2010-09-23
Last Posted Date
2024-07-26
Lead Sponsor
Andrew J. Wagner, MD, PhD
Target Recruit Count
17
Registration Number
NCT01207492
Locations
🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

H. Lee Moffitt Cancer Center, Tampa, Florida, United States

🇺🇸

Sarcoma Oncology Center, Santa Monica, California, United States

and more 4 locations

Tasigna in Glivec-resistant or Intolerant Patients in CML

First Posted Date
2010-09-21
Last Posted Date
2017-02-28
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
93
Registration Number
NCT01206088
Locations
🇰🇷

St. Mary hospital, Catholic medical center, Seoul, Korea, Republic of

A Study of Nilotinib in Growing Vestibular Schwannomas

Phase 2
Terminated
Conditions
Growing Vestibular Schwannomas
Interventions
Drug: Nilotinib
First Posted Date
2010-09-14
Last Posted Date
2017-01-11
Lead Sponsor
University Health Network, Toronto
Target Recruit Count
2
Registration Number
NCT01201538
Locations
🇨🇦

University Health Network, Toronto, Ontario, Canada

🇨🇦

Toronto Western Hospital, Toronto, Ontario, Canada

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