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

Effect of Calcium on Tasigna Pharmacokinetics (PK) in Healthy Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Nilotinib Hydrochloride
Dietary Supplement: calcium carbonate

First Posted Date: 2008-08-12

Last Posted Date: 2013-12-18

Lead Sponsor: Jan Beumer

Target Recruit Count: 14

Registration Number: NCT00732888

Locations: 🇺🇸
University of Pittsburgh Cancer Institute / Clinical and Translational Research Center (Hillman Cancer Center and Montefiore University Hospital locations), Pittsburgh, Pennsylvania, United States

Efficacy and Safety of AMN107 in Patients With GastroIntestinal Stromal Tumors (GIST) Who Have Failed Both Imatinib and Sunitinib

Phase 2

Completed

Conditions: Gastrointestinal Stromal Tumors

Interventions: Drug: AMN107

First Posted Date: 2008-07-18

Last Posted Date: 2017-02-23

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 35

Registration Number: NCT00718562

Locations: 🇯🇵
Novartis Investigative Site, Chuo-ku, Tokyo, Japan

Nilotinib and Imatinib Mesylate After Donor Stem Cell Transplant in Treating Patients With ALL or CML

Phase 1

Completed

Conditions: Philadelphia Positive Adult Acute Lymphoblastic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission
Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Recurrent Childhood Acute Lymphoblastic Leukemia
Accelerated Phase Chronic Myelogenous Leukemia
Childhood Acute Lymphoblastic Leukemia in Remission
Childhood Chronic Myelogenous Leukemia
Relapsing Chronic Myelogenous Leukemia
Untreated Adult Acute Lymphoblastic Leukemia
Untreated Childhood Acute Lymphoblastic Leukemia

Interventions: Drug: nilotinib
Drug: imatinib mesylate
Other: pharmacological study

First Posted Date: 2008-06-20

Last Posted Date: 2017-08-10

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 40

Registration Number: NCT00702403

Locations: 🇺🇸
H Lee Moffitt Cancer Center and Research Institute Phase 2 Consortium, Tampa, Florida, United States
🇺🇸
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States
🇺🇸
Stanford University Hospitals and Clinics, Stanford, California, United States

and more 2 locations

Study of Molecular Response in Adult Patients on Nilotinib With Philadelphia Chromosome Positive Chronic Myelogenous Leukemia (Ph+ CML) in Chronic Phase and a Suboptimal Molecular Response to Imatinib

Phase 2

Terminated

Conditions: Chronic Myelogenous Leukemia - Chronic Phase

Interventions: Drug: Nilotinib

First Posted Date: 2008-03-27

Last Posted Date: 2021-08-18

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 18

Registration Number: NCT00644878

Locations: 🇺🇸
USC Norris Cancer Center Jane Anne Nohl, Los Angeles, California, United States
🇺🇸
St. Agnes Hospital, Baltimore, Maryland, United States
🇺🇸
South Texas Institute of Cancer, Corpus Christi, Texas, United States

and more 8 locations

Nilotinib vs Imatinib in Adult Patients With Philadelphia (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

Phase 3

Terminated

Conditions: Myelogenous Leukemia

Interventions: Drug: Nilotinib (AMN107)
Drug: Imatinib

First Posted Date: 2007-08-21

Last Posted Date: 2011-11-06

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 6

Registration Number: NCT00519090

Locations: 🇺🇸
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
🇺🇸
Northwestern Memorial Hospital, Chicago, Illinois, United States
🇺🇸
Southern California Permanente Medical Group, San Diego, California, United States

and more 27 locations

Nilotinib as First-line Treatment of Ph+ CML in Early Chronic Phase

Phase 2

Completed

Conditions: Chronic Myeloid Leukemia

First Posted Date: 2007-06-01

Last Posted Date: 2022-01-18

Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

Target Recruit Count: 74

Registration Number: NCT00481052

Locations: 🇮🇹
Unità Operativa Ematologica - Università degli Studi di Bari, Bari, Italy
🇮🇹
Sezione di Ematologia e Trapianti Spedali Civili, Brescia, Italy
🇮🇹
Ospedale Ferrarotto, Catania, Italy

and more 19 locations

A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

Phase 3

Completed

Conditions: Myelogenous Leukemia, Chronic

Interventions: Drug: nilotinib
Drug: imatinib

First Posted Date: 2007-05-10

Last Posted Date: 2020-11-18

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 846

Registration Number: NCT00471497

Locations: 🇺🇸
University of California at Los Angeles Dept. of Hematology Clinic, Los Angeles, California, United States
🇺🇸
Kaiser Permanente - California Northern Kaiser Med, Vallejo, California, United States
🇺🇸
Florida Cancer Specialists Dept. FloridaCancerSpecialists, Fort Myers, Florida, United States

and more 29 locations

Efficacy and Safety of Nilotinib (AMN107) Compared With Current Treatment Options in Patients With GIST Who Have Failed Both Imatinib and Sunitinib

Phase 3

Completed

Conditions: Gastrointestinal Stromal Tumors

Interventions: Drug: Nilotinib
Other: Best Supportive Care (BSC) +/- imatinib or sunitinib

First Posted Date: 2007-05-09

Last Posted Date: 2012-06-12

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 248

Registration Number: NCT00471328

Locations: 🇺🇸
Washington University School of Medicine - Siteman Cancer Center, St. Louis, Missouri, United States
🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
University of Texas/MD Anderson Cancer Center, Houston, Texas, United States

and more 10 locations