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
Optimization of TKIs Treatment and Quality of Life in Ph+ CML Patients ≥60 Years in Deep Molecular Response
- Conditions
- Leukemia, Chronic Myeloid
- Interventions
- First Posted Date
- 2014-12-29
- Last Posted Date
- 2024-08-13
- Target Recruit Count
- 229
- Registration Number
- NCT02326311
- Locations
- 🇮🇹
Policlinico Universitario di Milano, Milano, Italy
Nilotinib in Cognitively Impaired Parkinson Disease Patients 001
- Conditions
- Diffuse Lewy Body DiseaseParkinson's Disease DementiaParkinson's Disease
- Interventions
- First Posted Date
- 2014-11-02
- Last Posted Date
- 2015-12-16
- Lead Sponsor
- Georgetown University
- Target Recruit Count
- 12
- Registration Number
- NCT02281474
- Locations
- 🇺🇸
MedStar Georgetown University Hospital, Washington, District of Columbia, United States
A Study of Imatinib and Nilotinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase
- First Posted Date
- 2014-10-23
- Last Posted Date
- 2019-08-19
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 225
- Registration Number
- NCT02272777
- Locations
- 🇨🇳
Novartis Investigative Site, Shanghai, China
The Life After Stopping Tyrosine Kinase Inhibitors Study (The LAST Study)
- Conditions
- Leukemia, Myeloid, Chronic
- Interventions
- First Posted Date
- 2014-10-21
- Last Posted Date
- 2023-03-03
- Lead Sponsor
- Medical College of Wisconsin
- Target Recruit Count
- 173
- Registration Number
- NCT02269267
- Locations
- 🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
🇺🇸Moffit Cancer Center, Tampa, Florida, United States
Safety and Tolerability of Combined Treatment With Nilotinib and Ruxolitinib in CML and Ph+ ALL Patients
- First Posted Date
- 2014-10-01
- Last Posted Date
- 2019-05-01
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 5
- Registration Number
- NCT02253277
- Locations
- 🇩🇪
Novartis Investigative Site, Leipzig, Germany
An Open-Label, Phase I/II Study of Nilotinib (Tasigna) and MEK-162 (ARRY-162) Used in Combination for Patients With Refractory or Advanced Chronic Myeloid Leukemia and Philadelphia Positive Acute Leukemia (Protocol CAMN107AUS41T)
- Conditions
- Leukemia
- Interventions
- First Posted Date
- 2014-08-26
- Last Posted Date
- 2020-02-12
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 1
- Registration Number
- NCT02225574
- Locations
- 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Nilotinib ± Peg-IFN for First Line Chronic Phase CML Patients
- Conditions
- Chronic Myeloid Leukemia
- Interventions
- First Posted Date
- 2014-07-28
- Last Posted Date
- 2014-08-07
- Lead Sponsor
- Hospices Civils de Lyon
- Target Recruit Count
- 200
- Registration Number
- NCT02201459
- Locations
- 🇫🇷
Franck NICOLINI, Lyon, France
An Open-label, Randomised Multicenter Phase 3b Study to Determine the Confirmed Rate of Molecular Response ≥ 4 Log (MR4) at Two Years
- First Posted Date
- 2014-06-25
- Last Posted Date
- 2019-12-02
- Lead Sponsor
- Prof. Dr. Nikolas von Bubnoff
- Target Recruit Count
- 14
- Registration Number
- NCT02174445
- Locations
- 🇩🇪
Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany
🇩🇪Universitätsklinikum Aachen, Aachen, Germany
🇩🇪Praxis Dr. Hauch, Erfurt, Germany
Trial to Evaluate the Improvement of Chronic Low-grade AEs in Patients With Ph+ CML With Optimal Response to Imatinib When Switched to Nilotinib
- Conditions
- Philadelphia Positive (Ph+) Chronic Myeloid Leukemia
- Interventions
- First Posted Date
- 2014-04-16
- Last Posted Date
- 2019-12-10
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 7
- Registration Number
- NCT02115386
- Locations
- 🇷🇺
Novartis Investigative Site, Moscow, Russian Federation
Study to Assess Efficacy and Safety of Nilotinib 300mg Twice Daily in Patients With Philadelphia Positive Chronic Myeloid Leukaemia (CML) in Chronic Phase Who Are Intolerant to Prior Tyrosine Kinase Inhibitors.
- Conditions
- Philidelphia Positive Chronic Myeloid Leukaemia
- Interventions
- First Posted Date
- 2014-04-09
- Last Posted Date
- 2017-10-27
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 20
- Registration Number
- NCT02108951
- Locations
- 🇦🇺
Novartis Investigative Site, Nedlands, Western Australia, Australia
Drug Development Updates
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