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
Study of Efficacy and Safety of Asciminib in Combination With Imatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CML-CP)
- Conditions
- CMLLeukemia, Myeloid ChronicHematologic DiseasesChronic Myelogenous Leukemia
- Interventions
- First Posted Date
- 2018-07-06
- Last Posted Date
- 2025-04-08
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 104
- Registration Number
- NCT03578367
- Locations
- 🇺🇸
Georgia Regents University, Augusta, Georgia, United States
🇺🇸Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
🇬🇧Novartis Investigative Site, Oxford, United Kingdom
Pembrolizumab and Dasatinib, Imatinib Mesylate, or Nilotinib in Treating Patients With Chronic Myeloid Leukemia and Persistently Detectable Minimal Residual Disease
- Conditions
- Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositiveMinimal Residual Disease
- Interventions
- Other: Laboratory Biomarker Analysis
- First Posted Date
- 2018-05-04
- Last Posted Date
- 2025-04-13
- Lead Sponsor
- ECOG-ACRIN Cancer Research Group
- Target Recruit Count
- 40
- Registration Number
- NCT03516279
- Locations
- 🇺🇸
Longmont United Hospital, Longmont, Colorado, United States
🇺🇸Fairbanks Memorial Hospital, Fairbanks, Alaska, United States
🇺🇸CTCA at Western Regional Medical Center, Goodyear, Arizona, United States
Efficacy and Safety of Nilotinib in CML-CP
- First Posted Date
- 2017-11-06
- Last Posted Date
- 2017-11-06
- Lead Sponsor
- Seoul National University Hospital
- Target Recruit Count
- 110
- Registration Number
- NCT03332511
Nilotinib Versus Imatinib in Treatment of Patients With Newly Diagnosed Chronic Myeloid Leukemia
- Conditions
- Chronic Myeloid Leukemia
- Interventions
- First Posted Date
- 2017-07-24
- Last Posted Date
- 2017-10-10
- Lead Sponsor
- Assiut University
- Target Recruit Count
- 100
- Registration Number
- NCT03228303
Dasatinib Versus Nilotinib for Treatment Naïve Chronic Myeloid Leukemia
- Conditions
- Chronic Myeloid Leukemia - Chronic Phase
- Interventions
- First Posted Date
- 2017-03-14
- Last Posted Date
- 2019-01-23
- Lead Sponsor
- Hamad Medical Corporation
- Target Recruit Count
- 10
- Registration Number
- NCT03079505
- Locations
- 🇶🇦
National Center for Cancer Care & Research (NCCCR), Doha, Qatar
A Study of Ruxolitinib in Combination With Nilotinib in Patients With Chronic Phase CML
- First Posted Date
- 2016-11-25
- Last Posted Date
- 2021-02-16
- Lead Sponsor
- University of Michigan Rogel Cancer Center
- Registration Number
- NCT02973711
- Locations
- 🇺🇸
The University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
🇺🇸Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
Impact of Nilotinib on Safety, Tolerability, Pharmacokinetics and Biomarkers in Parkinson's Disease
- Conditions
- Parkinson DiseaseParkinsons Disease With Dementia
- Interventions
- Drug: Placebo Oral Capsule
- First Posted Date
- 2016-11-04
- Last Posted Date
- 2019-03-14
- Lead Sponsor
- Georgetown University
- Target Recruit Count
- 75
- Registration Number
- NCT02954978
- Locations
- 🇺🇸
MedStar Georgetown University Hospital, Washington, District of Columbia, United States
Impact of Nilotinib on Safety, Biomarkers and Clinical Outcomes in Mild to Moderate Alzheimer's Disease
- Conditions
- Alzheimer's Disease
- Interventions
- Drug: Placebo Capsule(s) Once a Day by Mouth
- First Posted Date
- 2016-10-28
- Last Posted Date
- 2019-03-13
- Lead Sponsor
- Georgetown University
- Target Recruit Count
- 42
- Registration Number
- NCT02947893
- Locations
- 🇺🇸
Georgetown University Medical Center, Washington, District of Columbia, United States
The Drug Rediscovery Protocol (DRUP Trial)
- Conditions
- CancerTumorsNeoplasmNeoplasia
- Interventions
- First Posted Date
- 2016-10-05
- Last Posted Date
- 2024-01-24
- Lead Sponsor
- The Netherlands Cancer Institute
- Target Recruit Count
- 1550
- Registration Number
- NCT02925234
- Locations
- 🇳🇱
Meander medisch centrum, Amersfoort, Netherlands
🇳🇱Netherlands Cancer Institute, Amsterdam, Netherlands
🇳🇱Amsterdam UMC, locatie AMC, Amsterdam, Netherlands
2nd or 3rd TKI-stop After 2 Years Nilotinib Pre-treatment in CML-patients
- Conditions
- Chronic Myeloid Leukemia
- Interventions
- Other: TKI discontinuation
- First Posted Date
- 2016-09-28
- Last Posted Date
- 2023-12-11
- Lead Sponsor
- European LeukemiaNet
- Target Recruit Count
- 75
- Registration Number
- NCT02917720
- Locations
- 🇩🇪
Klinikum Chemnitz, Chemnitz, Germany
🇩🇪Onkologische Schwerpunktpraxis, Esslingen, Germany
🇩🇪Schwerpunktpraxis Onkologie, Heilbronn, Germany
Drug Development Updates
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