Nilotinib

Generic Name: Nilotinib

Brand Names: Tasigna, Nilotinib Accord

Drug Type: Small Molecule

Chemical Formula: C_₂₈H_₂₂F_₃N_₇O

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

Clinical Trials

Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients.

Phase 2

Completed

Conditions: Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia

Interventions: Drug: nilotinib

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

and more 8 locations

Phase I/II for Safety and Efficacy of Nilotinib in a Population Steroid-refractory/or Steroid-dependent cGVHD

Phase 1

Completed

Conditions: Chronic Graft Versus Host Disease

Interventions: Drug: nilotinib

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

and more 9 locations

Daunorubicin Hydrochloride, Cytarabine, and Nilotinib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

Phase 2

Completed

Conditions: Untreated Adult Acute Myeloid Leukemia

Interventions: Drug: Cytarabine
Drug: Daunorubicin Hydrochloride
Other: Laboratory Biomarker Analysis
Drug: Nilotinib
Other: Pharmacological Study

First Posted Date: 2013-03-07

Last Posted Date: 2023-05-31

Lead Sponsor: Mayo Clinic

Target Recruit Count: 34

Registration Number: NCT01806571

Locations: 🇺🇸
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
🇺🇸
Mayo Clinic, Rochester, Minnesota, United States

De- Escalation and Stopping Treatment of Imatinib, Nilotinib or sprYcel in Chronic Myeloid Leukaemia

Phase 2

Completed

Conditions: Chronic Myeloid Leukaemia

Interventions: Drug: Imatinib
Drug: nilotinib
Drug: dasatinib

First Posted Date: 2013-03-05

Last Posted Date: 2025-03-14

Lead Sponsor: University of Liverpool

Target Recruit Count: 174

Registration Number: NCT01804985

Locations: 🇬🇧
University of Liveprool, Liverpool, United Kingdom

Nilotinib Treatment-free Remission Study in CML (Chronic Myeloid Leukemia) Patients

Phase 2

Completed

Conditions: Chronic Myelogenous Leukemia

Interventions: Drug: Nilotinib followed by treatment-free

First Posted Date: 2013-02-05

Last Posted Date: 2025-03-30

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 215

Registration Number: NCT01784068

Locations: 🇺🇸
Florida Cancer Specialists, Fort Myers, Florida, United States
🇺🇸
Lakes Research, Miami Lakes, Florida, United States
🇺🇸
H Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

and more 8 locations

Multicenter Single-arm Pilot Study Evaluating Efficacy of Nilotinib in CML Patients With Molecular Relapse After Glivec Discontinuation Within the Context of the STIM Trials (STIM and STIM2)

Phase 2

Completed

Conditions: Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions: Drug: Nilotinib

First Posted Date: 2013-01-24

Last Posted Date: 2022-08-18

Lead Sponsor: University Hospital, Bordeaux

Target Recruit Count: 31

Registration Number: NCT01774630

Locations: 🇫🇷
Centre Hospitalier Lyon Sud, Service Hématologie, Pierre Benite, France
🇫🇷
CHU de Toulouse, Service d'Hématologie, Toulouse, France
🇫🇷
Centre Hospitalier de Versailles - Hôpital André Mignot - Service de Médecine B, Le Chesnay, France

and more 7 locations

Ruxolitinib in Treating Participants With Chronic Myeloid Leukemia With Minimal Residual Disease While on Therapy With Tyrosine Kinase Inhibitors

Phase 1

Terminated

Conditions: Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Minimal Residual Disease
Philadelphia Chromosome Positive, BCR-ABL1 Positive Chronic Myelogenous Leukemia
Chronic Myelogenous Leukemia, BCR-ABL1 Positive in Remission

Interventions: Drug: Dasatinib
Drug: Imatinib Mesylate
Drug: Nilotinib
Drug: Ruxolitinib

First Posted Date: 2012-12-18

Last Posted Date: 2024-08-26

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 8

Registration Number: NCT01751425

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

A Study That Switched Patients From Imatinib to Nilotinib and Then Was Followed by Treatment Cessation

Phase 2

Completed

Conditions: CML

Interventions: Drug: nilotinib

First Posted Date: 2012-12-07

Last Posted Date: 2020-03-10

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 59

Registration Number: NCT01744665

Locations: 🇺🇸
Compassionate Care Research Group Inc CCCMG, Fountain Valley, California, United States
🇺🇸
Michigan State University / Breslin Cancer Center Breslin Cancer Center (3), Lansing, Michigan, United States
🇺🇸
Hackensack University Medical Center John Theurer Cancer Center, Hackensack, New Jersey, United States

and more 51 locations

A Randomized Phase III Study to Assess the Effect of a Longer Duration of Consolidation Treatment With Nilotinib on TFR in CP CML.

Phase 3

Completed

Conditions: Philadelphia Chromosome Positive (PH+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

Interventions: Drug: Nilotinib

First Posted Date: 2012-12-06

Last Posted Date: 2021-07-15

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 620

Registration Number: NCT01743989

Locations: 🇬🇧
Novartis Investigative Site, London, United Kingdom

Study to Allow Access to Nilotinib for Patients Who Are on Nilotinib Treatment in a Novartis-sponsored Study

Phase 4

Completed

Conditions: Chronic Myelogenous Leukemia (CML)
Metastatic Gastrointestinal Stromal Tumors (GIST)
Acute Lymphoblastic Leukemia (ALL)
Receptor Tyrosine Kinase (KIT) Mutated Melanoma

Interventions: Drug: Nilotinib

First Posted Date: 2012-11-28

Last Posted Date: 2024-02-08

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 57

Registration Number: NCT01735955

Locations: 🇬🇧
Novartis Investigative Site, Newcastle upon Tyne, United Kingdom

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