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 Assessment of NIlotinib in CML Patients With Suboptimal Response on Imatinib Therapy
- First Posted Date
- 2014-03-13
- Last Posted Date
- 2017-03-07
- Target Recruit Count
- 98
- Registration Number
- NCT02086487
- Locations
- 🇸🇦
King Fahad specialist Hospital, Dammam, Eastern, Saudi Arabia
🇸🇦National Guard Hospital, Riyadh, Central, Saudi Arabia
A Phase I Study of Oral Asciminib (ABL001) in Patients With CML or Ph+ ALL
- Conditions
- Chronic Myelogenous LeukemiaPhiladelphia Chromosome-positive Acute Lymphoblastic Leukemia
- Interventions
- 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
Pharmacokinetic Comparison of XS003 and Tasigna
- First Posted Date
- 2014-02-21
- Last Posted Date
- 2014-11-11
- Lead Sponsor
- XSpray Microparticles
- Target Recruit Count
- 27
- Registration Number
- NCT02068898
- Locations
- 🇬🇧
Quotient Clinical, Nottingham, United Kingdom
Adapting Treatment to the Tumor Molecular Alterations for Patients With Advanced Solid Tumors: MyOwnSpecificTreatment
- Conditions
- Malignant Solid Neoplasms
- Interventions
- Combination Product: Durvalumab + Tremelimumab
- First Posted Date
- 2014-01-07
- Last Posted Date
- 2024-02-13
- Lead Sponsor
- Centre Leon Berard
- Target Recruit Count
- 900
- Registration Number
- NCT02029001
- Locations
- 🇫🇷
Centre Hospitalier Lyon Sud, Lyon, France
🇫🇷Institut Bergonié, Bordeaux, France
🇫🇷Institut Claudius Regaud, Toulouse, France
Phase I/II Study of Nilotinib/Ruxolitinb Therapy for TKI Resistant Ph-Leukemia
- Conditions
- Chronic Phase Chronic Myeloid LeukemiaAccelerated Phase Chronic Myeloid LeukemiaBlastic Phase Chronic Myeloid LeukemiaResistant to Tyrosine Kinase Inhibitor TherapyPhiladelphia Positive Acute Lymphoblastic Leukemia
- Interventions
- 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
- Recurrent Low-grade GliomasRefractory Low-grade Gliomas
- 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
A Phase I Study of Nilontinib and Cetuximab in Patients With Solid Tumors
- Conditions
- Colorectal CancerHead and Neck Cancer
- Interventions
- First Posted Date
- 2013-06-06
- Last Posted Date
- 2019-02-08
- Lead Sponsor
- Georgetown University
- Target Recruit Count
- 15
- Registration Number
- NCT01871311
- Locations
- 🇺🇸
Georgetown Lombardi Comprehensive Cancer Center, Washington, District of Columbia, United States
Nilotinib Plus Pegylated Interferon-α2b in CML
- Conditions
- Chronic Myeloid Leukemia
- Interventions
- Drug: Pegylated interferon α-2b
- 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
Nilotinib 300 mg BID in Newly Diagnosed CP-CML Patients to Verify Disappearance of CD34+/Lin-Ph+ Cells
- First Posted Date
- 2013-05-17
- Last Posted Date
- 2021-01-13
- Lead Sponsor
- Niguarda Hospital
- Target Recruit Count
- 87
- Registration Number
- NCT01856283
- Locations
- 🇮🇹
Ospedale San Raffaele, Milano, Italy
🇮🇹A.O di Circolo di Busto Arsizio, Busto Arsizio, Varese, Italy
🇮🇹Ospedali Riuniti Bergamo, Bergamo, Italy
Drug Development Updates
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