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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
Clinical Trials
Related News

Bioavailability Study Comparing Two New Nilotinib Tablet Formulations to an Established Nilotinib Capsule Formulation in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2007-01-05
Last Posted Date
2020-12-09
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
24
Registration Number
NCT00418769

Oral Nilotinib in Adults With Chronic Myeloid Leukemia (CML) in Blast Crisis Who Are Imatinib Resistant or Intolerant

Conditions
Chronic Myelogenous Leukemia
First Posted Date
2006-12-19
Last Posted Date
2011-07-13
Lead Sponsor
Novartis Pharmaceuticals
Registration Number
NCT00413270
Locations
🇨🇦

Novartis Investigative Site, Quebec, Canada

A Phase l/ll Study of AMN107 in Adult Patients With Glivec-intolerant CML or Relapsed-refractory Ph+ALL

Phase 1
Completed
Conditions
Chronic Myelogenous Leukemia
Acute Lymphoblastic Leukemia (Philadelphia Chromosome Positive)
Interventions
First Posted Date
2006-10-06
Last Posted Date
2020-12-08
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
42
Registration Number
NCT00384228
Locations
🇯🇵

Novartis Investigative Site, Tokyo, Japan

Expanded Access Program of AMN107 in Imatinib-resistant or Intolerant Adult Patients With Chronic Myeloid Leukemia

Conditions
Chronic Myeloid Leukemia
First Posted Date
2006-03-13
Last Posted Date
2011-08-26
Lead Sponsor
Novartis Pharmaceuticals
Registration Number
NCT00302016
Locations
🇺🇸

Rush University Medical Center, Chicago, Illinois, United States

🇺🇸

Stroger Cook County Hospital, Chicago, Illinois, United States

🇺🇸

Swedish Cancer Institute, Seattle, Washington, United States

and more 56 locations

Efficacy and Safety of Oral AMN107 in Adults With Chronic Myelogenous Leukemia Resistant and/or Intolerant to Imatinib Mesylate Therapy

Phase 2
Completed
Conditions
Leukemia, Myeloid, Chronic
Interventions
First Posted Date
2005-12-12
Last Posted Date
2017-03-06
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
36
Registration Number
NCT00264160
Locations
🇮🇱

Novartis Investigative Site, Tel Hashomer, Israel

Phase II Nilotinib With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML)

Phase 2
Completed
Conditions
Leukemia, Myelogenous, Chronic
Interventions
First Posted Date
2005-08-12
Last Posted Date
2019-09-24
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
148
Registration Number
NCT00129740
Locations
🇺🇸

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

A Study of Oral AMN107 in Adults With Chronic Myelogenous Leukemia (CML) or Other Hematologic Malignancies

Phase 1
Completed
Conditions
Chronic Myelogenous Leukemia
Acute Lymphoblastic Leukemia (Philadelphia Chromosome Positive)
Hypereosinophilic Syndrome
Systemic Mastocytosis
Interventions
First Posted Date
2005-05-03
Last Posted Date
2021-06-29
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
507
Registration Number
NCT00109707
Locations
🇺🇸

Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins Med. Div.of Hematologic Malignancie, Baltimore, Maryland, United States

🇺🇸

Stanford University Medical Center, Stanford, California, United States

🇺🇸

University of Chicago Medical Center Dept. of U. of Chicago Hosp(3), Chicago, Illinois, United States

and more 22 locations

Fludarabine Phosphate and Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate, Dasatinib, or Nilotinib

Phase 2
Completed
Conditions
Recurrent Adult Acute Lymphoblastic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission
Blastic Phase
Childhood Acute Lymphoblastic Leukemia in Remission
Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Recurrent Childhood Acute Lymphoblastic Leukemia
Recurrent Disease
Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
Chronic Phase of Disease
Interventions
Procedure: Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation
Procedure: Peripheral Blood Stem Cell Transplantation
Biological: Therapeutic Allogeneic Lymphocytes
Radiation: Total-Body Irradiation
First Posted Date
2003-01-27
Last Posted Date
2020-01-29
Lead Sponsor
Fred Hutchinson Cancer Center
Target Recruit Count
28
Registration Number
NCT00036738
Locations
🇺🇸

VA Puget Sound Health Care System, Seattle, Washington, United States

🇺🇸

Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

🇺🇸

Presbyterian - Saint Lukes Medical Center - Health One, Denver, Colorado, United States

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