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
Efficacy and Safety of TKIs' Withdrawal After a Two-step Dose Reduction in Patients with Chronic Myeloid Leukemia
- Conditions
- Withdrawal;DrugChronic Myeloid Leukemia, Chronic Phase
- Interventions
- First Posted Date
- 2019-11-01
- Last Posted Date
- 2024-11-26
- Lead Sponsor
- Masaryk University
- Target Recruit Count
- 150
- Registration Number
- NCT04147533
- Locations
- 🇨🇿
University Hospital Kralovske Vinohrady, Praha, Czechia
🇨🇿Insitute of Hematology and Blood Transfusion, Praha, Czechia
🇨🇿University Hospital Plzen, Plzen, Czechia
Impact of Nilotinib on Safety, Tolerability, Pharmacokinetics and Biomarkers in Dementia With Lewy Bodies
- Conditions
- Dementia With Lewy Bodies
- Interventions
- Drug: Placebo oral capsule
- First Posted Date
- 2019-06-28
- Last Posted Date
- 2023-05-15
- Lead Sponsor
- Georgetown University
- Target Recruit Count
- 60
- Registration Number
- NCT04002674
- Locations
- 🇺🇸
MedStar Georgetown University Hospital, Washington, District of Columbia, United States
Nilotinib for First-line Newly Diagnosed CML-CP Patients
- First Posted Date
- 2019-05-08
- Last Posted Date
- 2022-03-16
- Lead Sponsor
- Shenzhen Second People's Hospital
- Target Recruit Count
- 100
- Registration Number
- NCT03942094
- Locations
- 🇨🇳
Shenzhen Second People's Hospital, Shenzhen, Guangdong, China
Effect of Nilotinib in Cerebellar Ataxia Patients
- First Posted Date
- 2019-05-01
- Last Posted Date
- 2021-09-29
- Lead Sponsor
- Seoul National University Hospital
- Target Recruit Count
- 70
- Registration Number
- NCT03932669
- Locations
- 🇰🇷
Seoul National University Hospital, Seoul, Korea, Republic of
Frontline Asciminib Combination in Chronic Phase CML
- Conditions
- Chronic Myeloid Leukemia
- Interventions
- First Posted Date
- 2019-04-08
- Last Posted Date
- 2025-03-10
- Lead Sponsor
- University of Jena
- Target Recruit Count
- 125
- Registration Number
- NCT03906292
- Locations
- 🇩🇪
Universitätsklinikum Aachen Medizinische Klinik IV, Aachen, Germany
🇩🇪Klinikum Bremen Mitte, Bremen, Germany
🇩🇪Charite Universitätsmeditin Berlin, Campus Virchow Klinikum, Berlin, Germany
Precision Dosing of Tyrosine Kinase Inhibitors in CML Patients
- Conditions
- CML - Philadelphia ChromosomeChronic Myeloid LeukemiaChronic Myeloid Leukemia, Chronic PhaseCML, Chronic PhaseCML (Chronic Myelogenous Leukemia
- Interventions
- First Posted Date
- 2019-03-22
- Last Posted Date
- 2023-01-11
- Lead Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Target Recruit Count
- 45
- Registration Number
- NCT03885830
- Locations
- 🇺🇸
UNC Hospital, Chapel Hill, North Carolina, United States
De-escalation and TFR Study in CML Patients Treated With Nilotinib Followed by a Second Attempt After Nilotinib and Asciminib Combination
- Conditions
- Chronic Myeloid Leukemia
- Interventions
- First Posted Date
- 2019-03-14
- Last Posted Date
- 2025-05-06
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 124
- Registration Number
- NCT03874858
- Locations
- 🇮🇹
Novartis Investigative Site, Novara, Italy
Molecular Profiling of Advanced Soft-tissue Sarcomas
- Conditions
- Soft Tissue Sarcoma
- Interventions
- Other: Next Generation sequencing exomeCombination Product: Trametinib and DabrafenibCombination Product: Olaparib and Durvalumab
- First Posted Date
- 2018-12-21
- Last Posted Date
- 2025-01-28
- Lead Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
- Target Recruit Count
- 603
- Registration Number
- NCT03784014
- Locations
- 🇫🇷
Centre Oscar Lambret, Lille, France
🇫🇷IUCT Oncopôle, Toulouse, France
🇫🇷Institut de Cancérologie de Montpellier, Montpellier, France
Nilotinib in Huntington's Disease
- First Posted Date
- 2018-12-05
- Last Posted Date
- 2020-02-20
- Lead Sponsor
- Georgetown University
- Target Recruit Count
- 10
- Registration Number
- NCT03764215
- Locations
- 🇺🇸
Georgetown University Medical Center, Washington, District of Columbia, United States
Testing the Addition of Ruxolitinib to the Usual Treatment (Tyrosine Kinase Inhibitors) for Chronic Myeloid Leukemia
- Conditions
- Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Interventions
- Other: Laboratory Biomarker Analysis
- First Posted Date
- 2018-08-31
- Last Posted Date
- 2024-07-08
- Lead Sponsor
- SWOG Cancer Research Network
- Target Recruit Count
- 84
- Registration Number
- NCT03654768
- Locations
- 🇺🇸
Anchorage Associates in Radiation Medicine, Anchorage, Alaska, United States
🇺🇸Anchorage Radiation Therapy Center, Anchorage, Alaska, United States
🇺🇸Alaska Breast Care and Surgery LLC, Anchorage, Alaska, United States
Drug Development Updates
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