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
KRT-232 and TKI Study in Chronic Myeloid Leukemia
- Conditions
- Chronic Myeloid Leukemia
- Interventions
- First Posted Date
- 2021-04-08
- Last Posted Date
- 2022-03-21
- Lead Sponsor
- Kartos Therapeutics, Inc.
- Target Recruit Count
- 109
- Registration Number
- NCT04835584
- Locations
- 🇺🇸
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
🇮🇹Azienda Ospedaliero - Universitaria Mater Domini, Catanzaro, Italy
🇮🇹Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
Protocol Number: HJKC3-0003. Treatment Free Remission After Combination Therapy With Asciminib (ABL001) Plus Tyrosine Kinase Inhibitors (TKI) in Chronic Phase Chronic Myeloid Leukemia (CP-CML) Patients Who Relapsed After a Prior Attempt at TKI Discontinuation
- Conditions
- Chronic Phase Chronic Myelogenous Leukemia
- Interventions
- First Posted Date
- 2021-04-08
- Last Posted Date
- 2025-04-23
- Lead Sponsor
- Medical College of Wisconsin
- Target Recruit Count
- 51
- Registration Number
- NCT04838041
- Locations
- 🇺🇸
The Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
🇺🇸Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸Huntsman Cancer Institute, Salt Lake City, Utah, United States
Flumatinib Versus Nilotinib for Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia
- Conditions
- CML, Chronic Phase; TKI
- Interventions
- First Posted Date
- 2021-02-05
- Last Posted Date
- 2023-11-03
- Lead Sponsor
- The First Affiliated Hospital of Soochow University
- Target Recruit Count
- 491
- Registration Number
- NCT04739826
- Locations
- 🇨🇳
The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology, Suzhou, Jiangsu, China
Evaluating Efficacy and Safety of Flumatinib for Chronic Phase Chronic Myeloid Leukemia(CML-CP) Without Optimal Response (Warning,Failure) to Imatinib or Dasatinib
- Conditions
- CML-CP; Mutation;Suboptimal Response or Failure in TKI
- Interventions
- First Posted Date
- 2020-12-23
- Last Posted Date
- 2023-08-01
- Lead Sponsor
- Wuhan Union Hospital, China
- Target Recruit Count
- 200
- Registration Number
- NCT04681820
- Locations
- 🇨🇳
Weiming Li, Wuhan, Hubei, China
A Study of REduction And DIscontinuation Treatment of TKI (Imatinib, Nilotinib, Dasatinib and Bosutinib)
- Conditions
- Chronic Myeloid LeukemiaChronic Myeloid Leukemia in RemissionBCR-ABL Positive Chronic Myelogenous Leukemia
- Interventions
- First Posted Date
- 2020-10-08
- Last Posted Date
- 2020-10-08
- Lead Sponsor
- National Research Center for Hematology, Russia
- Target Recruit Count
- 100
- Registration Number
- NCT04578847
- Locations
- 🇷🇺
National Research Center for Hematology, Moscow, Russian Federation
MAP to Provide Access to Nilotinib, for Patients With Relapsed or Refractory Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
- Conditions
- Acute Lymphoblastic Leukemia (ALL)
- First Posted Date
- 2020-09-23
- Last Posted Date
- 2022-08-09
- Lead Sponsor
- Novartis Pharmaceuticals
- Registration Number
- NCT04559555
Nilotinib, for Patients With CML-CP or CML-AP
- Conditions
- Chronic Myelogenous Leukemia (CML)
- First Posted Date
- 2020-08-19
- Last Posted Date
- 2023-04-28
- Lead Sponsor
- Novartis Pharmaceuticals
- Registration Number
- NCT04518644
MAP to Provide Access to Nilotinib, for Patients With HES
- Conditions
- Hypereosinophilic Syndrome (HES)
- First Posted Date
- 2020-08-05
- Last Posted Date
- 2021-09-20
- Lead Sponsor
- Novartis Pharmaceuticals
- Registration Number
- NCT04498871
Rapid Analysis and Response Evaluation of Combination Anti-Neoplastic Agents in Rare Tumors (RARE CANCER) Trial: RARE 1 Nilotinib and Paclitaxel
- First Posted Date
- 2020-06-29
- Last Posted Date
- 2025-05-18
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 82
- Registration Number
- NCT04449549
- Locations
- 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States
Nilotinib in Preventing Paclitaxel-Induced Peripheral Neuropathy in Patients with Stage I-III Breast Cancer
- Conditions
- Anatomic Stage I Breast Cancer AJCC V8Anatomic Stage IA Breast Cancer AJCC V8Anatomic Stage III Breast Cancer AJCC V8Anatomic Stage IB Breast Cancer AJCC V8Anatomic Stage II Breast Cancer AJCC V8Anatomic Stage IIA Breast Cancer AJCC V8Anatomic Stage IIB Breast Cancer AJCC V8Anatomic Stage IIIA Breast Cancer AJCC V8Anatomic Stage IIIB Breast Cancer AJCC V8Anatomic Stage IIIC Breast Cancer AJCC V8
- Interventions
- Other: PlaceboOther: Questionnaire Administration
- First Posted Date
- 2019-12-20
- Last Posted Date
- 2025-02-12
- Target Recruit Count
- 11
- Registration Number
- NCT04205903
- Locations
- 🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Drug Development Updates
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