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
- -
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
- 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
- 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
A Phase I Study of Oral Asciminib (ABL001) in Patients With CML or Ph+ ALL
- First Posted Date
- 2014-03-07
- Last Posted Date
- 2024-03-18
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 326
- Registration Number
- NCT02081378
- Locations
- 🇺🇸
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering, New York, New York, United States
🇪🇸Novartis Investigative Site, Madrid, Spain
🇺🇸Dana Farber Cancer Institute Hematology / Oncology, Boston, Massachusetts, United States
Phase I/II Study of Nilotinib/Ruxolitinb Therapy for TKI Resistant Ph-Leukemia
- First Posted Date
- 2013-08-02
- Last Posted Date
- 2020-11-02
- Lead Sponsor
- University Health Network, Toronto
- Target Recruit Count
- 4
- Registration Number
- NCT01914484
- Locations
- 🇨🇦
Princess Margaret Hospital / University Health Network, Toronto, Ontario, Canada
Study Of Vinblastine in Combination With Nilotinib in Children, Adolescents and Young Adults
- Conditions
- Interventions
- First Posted Date
- 2013-06-24
- Last Posted Date
- 2022-05-27
- Lead Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Target Recruit Count
- 35
- Registration Number
- NCT01884922
- Locations
- 🇨🇭
Swiss Pediatric Oncology Group, Bern, Switzerland
🇳🇱Erasmus MC/Sophia Children's Hospital, Rotterdam, Netherlands
🇬🇧Cancer Research UK Clinical Trials Unit School of Cancer Sciences University of Birmingham, Edgbaston, Birmingham, United Kingdom
Nilotinib Plus Pegylated Interferon-α2b in CML
- Conditions
- Interventions
- First Posted Date
- 2013-05-31
- Last Posted Date
- 2018-10-12
- Lead Sponsor
- Amsterdam UMC, location VUmc
- Target Recruit Count
- 20
- Registration Number
- NCT01866553
- Locations
- 🇫🇮
Helsinki University Hospital, Helsinki, Finland
🇳🇱VU University Medical Center, Amsterdam, Netherlands
🇳🇴Trondheim University Hospital, Trondheim, Norway
Nilotinib Roll-over Protocol for Patients in Novartis-sponsored Nilotinib Study and Benefiting From Nilotinib Treatment
- First Posted Date
- 2013-05-29
- Last Posted Date
- 2024-08-19
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 15
- Registration Number
- NCT01863745
- Locations
- 🇯🇵
Novartis Investigative Site, Chuo ku, Tokyo, Japan
Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients.
- Conditions
- Interventions
- First Posted Date
- 2013-05-01
- Last Posted Date
- 2021-04-22
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 59
- Registration Number
- NCT01844765
- Locations
- 🇺🇸
Loma Linda University Cancer Center, Loma Linda, California, United States
🇺🇸Nationwide Childrens Hospital, Columbus, Ohio, United States
🇺🇸Seattle Childrens Hospital, Seattle, Washington, United States
Phase I/II for Safety and Efficacy of Nilotinib in a Population Steroid-refractory/or Steroid-dependent cGVHD
- First Posted Date
- 2013-03-13
- Last Posted Date
- 2023-03-10
- Lead Sponsor
- Gruppo Italiano Trapianto di Midollo Osseo
- Target Recruit Count
- 22
- Registration Number
- NCT01810718
- Locations
- 🇮🇹
U.O. Ematologia I - Centro Trapianti di Midollo - Ospedale Maggiore - Policlinico Mangiagalli e Regina Elena, Milano, Italy
🇮🇹Centro Unico Regionale Trapianti di Midollo Osseo - Ospedale Bianchi-Melacino-Morelli, Reggio Calabria, Italy
🇮🇹Clinica Ematologica - AOU Santa Maria Della Misericordia, Udine, Italy
Drug Development Updates
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