Nilotinib (AMN-107) Clinical Trials

Size	Price	Qty
25mg	USD 147
100mg	USD 297

Clinical Trials

Sponsored by academic centers, cooperative groups, government institutions, and industry partners, numerous clinical trials have evaluated nilotinib across early to late phases, encompassing recruiting, active, and completed statuses. These studies investigate nilotinib as monotherapy or in combination with agents such as asciminib or paclitaxel for hematologic malignancies—specifically chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia—as well as peritoneal carcinomatosis and dementia with Lewy bodies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07493408	NOT_YET_RECRUITING	Ph+ Acute Lymphoblastic Leukemia (Ph+ALL); Blastic Transformation of Chronic Myeloid Leukemia; Philadelphia Chromosome-positive B-cell Acute Lymphoblastic Leukemia (Ph+ B-ALL); Haematopoietic Stem Cell Transplant, Allogeneic	The University of Hong Kong	2026-03-30	PHASE2
NCT01746836	RECRUITING	Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Philadelphia Chromosome Positive, BCR-ABL1 Positive Chronic Myelogenous Leukemia; Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive	M.D. Anderson Cancer Center	2013-01-17	PHASE2
NCT04877522	RECRUITING	Chronic Myelogenous Leukemia; Leukemia, Myelogenous, Chronic, BCR-ABL Positive	Novartis Pharmaceuticals	2022-08-30	PHASE4
NCT05564377	RECRUITING	Advanced Malignant Solid Neoplasm; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Locally Advanced Malignant Solid Neoplasm; Malignant Female Reproductive System Neoplasm; Metastatic HER2-Negative Breast Carcinoma; Metastatic Malignant Solid Neoplasm; Recurrent Endometrial Carcinoma; Recurrent Fallopian Tube Carcinoma; Recurrent Malignant Female Reproductive System Neoplasm; Recurrent Malignant Solid Neoplasm; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma; Unresectable HER2-Negative Breast Carcinoma; Unresectable Malignant Solid Neoplasm	National Cancer Institute (NCI)	2023-04-07	PHASE2
NCT06409936	RECRUITING	CML, Chronic Phase; Chronic Myeloid Leukemia, Chronic Phase; Chronic Myeloid Leukemia, BCR/ABL-Positive; Chronic Myeloid Leukemia	Gruppo Italiano Malattie EMatologiche dell'Adulto	2025-06-26	PHASE2
NCT04626024	ACTIVE_NOT_RECRUITING	Chronic Myeloid Leukemia; Chronic Myeloid Leukemia, BCR/ABL-Positive, in Remission; Chronic Myeloid Leukemia in Remission	Baylor College of Medicine	2020-12-22	PHASE2
NCT03516279	ACTIVE_NOT_RECRUITING	Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Minimal Residual Disease	ECOG-ACRIN Cancer Research Group	2019-06-26	PHASE2
NCT04903119	RECRUITING	Metastatic Melanoma; BRAF Gene Mutation	Rina Plattner	2022-06-01	PHASE1
NCT04838041	RECRUITING	Chronic Phase Chronic Myelogenous Leukemia	Medical College of Wisconsin	2021-11-11	PHASE2
NCT02029001	RECRUITING	Malignant Solid Neoplasms	Centre Leon Berard	2014-03	PHASE2
NCT02925234	RECRUITING	Cancer; Tumors; Neoplasm; Neoplasia	The Netherlands Cancer Institute	2016-08	PHASE2
NCT05554341	ACTIVE_NOT_RECRUITING	Metastatic Malignant Solid Neoplasm; Refractory Malignant Solid Neoplasm	National Cancer Institute (NCI)	2023-07-14	PHASE2
NCT04449549	RECRUITING	Neoplasms	National Cancer Institute (NCI)	2020-08-24	PHASE2
NCT03906292	ACTIVE_NOT_RECRUITING	Chronic Myeloid Leukemia	University of Jena	2019-08-19	PHASE2
NCT02917720	ACTIVE_NOT_RECRUITING	Chronic Myeloid Leukemia	European LeukemiaNet	2016-09	PHASE2
NCT04147533	ACTIVE_NOT_RECRUITING	Chronic Myeloid Leukemia, Chronic Phase; Withdrawal;Drug	Masaryk University	2020-06-16	PHASE2
NCT05143528	UNKNOWN	Alzheimer Disease	KeifeRx, LLC	2022-02-01	PHASE3
NCT03874858	TERMINATED	Chronic Myeloid Leukemia	Novartis Pharmaceuticals	2019-03-22	PHASE2
NCT01316250	COMPLETED	Chronic Myelogenous Leukemia	American University of Beirut Medical Center	2010-08
NCT05456191	ACTIVE_NOT_RECRUITING	Philadelphia Chromosome-Positive Chronic Myeloid Leukemia	Novartis Pharmaceuticals	2022-11-21	PHASE3
NCT02379416	COMPLETED	Solid Tumors	National Cancer Institute (NCI)	2015-04-13	PHASE1
NCT04002674	COMPLETED	Dementia With Lewy Bodies	Georgetown University	2019-07-01	PHASE2
NCT05185947	COMPLETED	Gynecologic Cancer; Gynecologic Neoplasms; Peritoneal Carcinomatosis; Peritoneal Neoplasms; Ovarian Cancer; Ovarian Neoplasms; Colorectal Cancer; Colorectal Neoplasms; Appendiceal Cancer; Appendiceal Neoplasms; Cholangiocarcinoma; Breast Cancer	National Cancer Institute (NCI)	2022-10-13	PHASE2
NCT04578847	UNKNOWN	Chronic Myeloid Leukemia; Chronic Myeloid Leukemia in Remission; BCR-ABL Positive Chronic Myelogenous Leukemia	National Research Center for Hematology, Russia	2020-01-15	PHASE2
NCT07138352	COMPLETED	Cancer	Xspray Pharma AB	2024-10-03	PHASE1
NCT04835584	UNKNOWN	Chronic Myeloid Leukemia	Kartos Therapeutics, Inc.	2021-05-07	PHASE1; PHASE2
NCT00756509	COMPLETED	Gastrointestinal Stromal Tumors	Novartis Pharmaceuticals	2008-08-29	PHASE4
NCT07138378	COMPLETED	Cancer	Xspray Pharma AB	2024-11-15	PHASE1
NCT06409936	Not yet recruiting	CML Chronic Phase\|Chronic Myeloid Leukemia Chronic Phase\|Chronic Myeloid Leukemia BCR/ABL-Positive\|Chronic Myeloid Leukemia	Gruppo Italiano Malattie EMatologiche dell''Adulto\|Fundacion Espanola para la Curacion de la Leucemia Mieloide Cronica	2024-09	Phase 2
NCT04126681	COMPLETED	Chronic Myeloid Leukemia, Chronic Phase	Ascentage Pharma Group Inc.	2019-10-21	PHASE2
NCT03654768	ACTIVE_NOT_RECRUITING	Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive	SWOG Cancer Research Network	2018-10-24	PHASE2
NCT04205903	COMPLETED	Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage IA Breast Cancer AJCC v8; Anatomic Stage IB Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Anatomic Stage IIB Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Anatomic Stage IIIB Breast Cancer AJCC v8; Anatomic Stage IIIC Breast Cancer AJCC v8; Prognostic Stage I Breast Cancer AJCC v8; Prognostic Stage IA Breast Cancer AJCC v8; Prognostic Stage IB Breast Cancer AJCC v8; Prognostic Stage II Breast Cancer AJCC v8; Prognostic Stage IIA Breast Cancer AJCC v8; Prognostic Stage IIB Breast Cancer AJCC v8; Prognostic Stage III Breast Cancer AJCC v8; Prognostic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage IIIB Breast Cancer AJCC v8; Prognostic Stage IIIC Breast Cancer AJCC v8	Ohio State University Comprehensive Cancer Center	2020-12-11	PHASE1
NCT02326311	COMPLETED	Leukemia, Chronic Myeloid	Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia	2015-06-10	PHASE3
NCT03784014	COMPLETED	Soft Tissue Sarcoma	Institut National de la Santé Et de la Recherche Médicale, France	2019-10-19	PHASE3
NCT04971226	ACTIVE_NOT_RECRUITING	Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive	Novartis Pharmaceuticals	2021-10-06	PHASE3
NCT01863745	COMPLETED	Gastrointestinal Stromal Tumors	Novartis Pharmaceuticals	2013-06-25	PHASE2
NCT01735955	COMPLETED	Chronic Myelogenous Leukemia (CML); Metastatic Gastrointestinal Stromal Tumors (GIST); Acute Lymphoblastic Leukemia (ALL); Receptor Tyrosine Kinase (KIT) Mutated Melanoma	Novartis Pharmaceuticals	2013-03-29	PHASE4
NCT03942094	UNKNOWN	Chronic Myeloid Leukemia, Chronic Phase; Nilotinib	Shenzhen Second People's Hospital	2019-06-01	PHASE3
NCT02602314	UNKNOWN	Chronyc Myeloid Leukemia	Gruppo Italiano Malattie EMatologiche dell'Adulto	2016-11-11	PHASE4
NCT05185947	Recruiting	Gynecologic Cancer\|Gynecologic Neoplasms\|Peritoneal Carcinomatosis\|Peritoneal Neoplasms\|Ovarian Cancer\|Ovarian Neoplasms\|Colorectal Cancer\|Colorectal Neoplasms\|Appendiceal Cancer\|Appendiceal Neoplasms	National Cancer Institute (NCI)\|National Institutes of Health Clinical Center (CC)	2022-10-13	Phase 2
NCT02201459	COMPLETED	Chronic Myeloid Leukemia	Hospices Civils de Lyon	2014-08	PHASE3
NCT01657604	COMPLETED	Chronic Myeloid Leukemia	University of Jena	2012-08-24	PHASE3
NCT02001818	COMPLETED	Chronic Myeloid Leukaemia	Australasian Leukaemia and Lymphoma Group	2014-04-11	PHASE2
NCT03578367	COMPLETED	CML; Chronic Myelogenous Leukemia; Leukemia, Myeloid Chronic; Hematologic Diseases	Novartis Pharmaceuticals	2018-11-22	PHASE2
NCT02973711	WITHDRAWN	Leukemia, Chronic Myeloid	University of Michigan Rogel Cancer Center	2018-01	PHASE1; PHASE2
NCT02081378	COMPLETED	Chronic Myelogenous Leukemia; Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia	Novartis Pharmaceuticals	2014-04-24	PHASE1
NCT02269267	COMPLETED	Leukemia, Myeloid, Chronic	Medical College of Wisconsin	2014-12-18	PHASE2
NCT02546674	COMPLETED	Chronic Myeloid Leukemia	Novartis Pharmaceuticals	2016-02-18	PHASE4
NCT02353728	COMPLETED	Chronic Myeloid Leukemia	Weill Medical College of Cornell University	2015-01	PHASE2
NCT01774630	COMPLETED	Leukemia, Myelogenous, Chronic, BCR-ABL Positive	University Hospital, Bordeaux	2013-04-10	PHASE2
NCT02947893	COMPLETED	Alzheimer's Disease	Georgetown University	2017-01	PHASE2
NCT02611492	UNKNOWN	Philadelphia Chromosome Positive Adult Acute Lymphoblastic Leukemia	Assistance Publique - Hôpitaux de Paris	2016-04	PHASE3
NCT03764215	UNKNOWN	Huntington Disease	Georgetown University	2018-11-15	PHASE1
NCT02627677	TERMINATED	Chronic Phase Chronic Myeloid Leukemia	Ariad Pharmaceuticals	2015-12-31	PHASE3
NCT04448821	COMPLETED	Healthy	Hyewon Chung	2020-07-23	PHASE1
NCT03932669	COMPLETED	Ataxia, Cerebellar; Ataxia, Progressive	Seoul National University Hospital	2018-11-19	PHASE2
NCT03228303	UNKNOWN	Chronic Myeloid Leukemia	Assiut University	2017-12-01	EARLY_PHASE1
NCT01743989	COMPLETED	Philadelphia Chromosome Positive (PH+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)	Novartis Pharmaceuticals	2013-04-15	PHASE3
NCT01856283	COMPLETED	Leukemia, Myeloid, Chronic-Phase	Niguarda Hospital	2013-03	PHASE2
NCT02954978	COMPLETED	Parkinson Disease; Parkinsons Disease With Dementia	Georgetown University	2017-01	PHASE2
NCT01528085	COMPLETED	Philadelphia Chromsome Positive Acute Lymphoblastic Leukemia	Goethe University	2012-01	PHASE2
NCT04326933	Unknown status	Patients Diagnosed as Chronic Meyloid Leukemia	Assiut University	2020-01-01	--
NCT03205267	UNKNOWN	Chronic Myelogenous Leukaemia	University of Bonn	2016-03	PHASE2
NCT01751425	TERMINATED	Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Chronic Myelogenous Leukemia, BCR-ABL1 Positive in Remission; Minimal Residual Disease; Philadelphia Chromosome Positive, BCR-ABL1 Positive Chronic Myelogenous Leukemia	M.D. Anderson Cancer Center	2013-07-24	PHASE1
NCT01690065	UNKNOWN	Chronic Myeloid Leukemia in Myeloid Blast Crisis; Untreated Adult Acute Myeloid Leukemia	Ulsan University Hospital	2012-09	PHASE2
NCT03205488	COMPLETED	Parkinson Disease	Northwestern University	2017-10-16	PHASE2
NCT03214718	UNKNOWN	Chronic Myeloid Leukemia Patients	Assiut University	2017-08-05
NCT01274351	COMPLETED	Chronic Myelogenous Leukemia	Novartis Pharmaceuticals	2011-01-25	PHASE2
NCT04002674	Recruiting	Dementia With Lewy Bodies	Georgetown University\|National Institutes of Health (NIH)	2019-07-01	Phase 2
NCT01887522	TERMINATED	Refractory Low-grade Gliomas; Recurrent Low-grade Gliomas	Gustave Roussy, Cancer Campus, Grand Paris	2016-07-06	PHASE2
NCT01914484	COMPLETED	Chronic Phase Chronic Myeloid Leukemia; Accelerated Phase Chronic Myeloid Leukemia; Blastic Phase Chronic Myeloid Leukemia; Philadelphia Positive Acute Lymphoblastic Leukemia; Resistant to Tyrosine Kinase Inhibitor Therapy	University Health Network, Toronto	2013-08-01	PHASE1; PHASE2
NCT02174445	TERMINATED	Chronic Myeloid Leukemia	Prof. Dr. Nikolas von Bubnoff	2014-03	PHASE3
NCT01744665	COMPLETED	CML	Novartis Pharmaceuticals	2013-08-12	PHASE2
NCT03079505	TERMINATED	Chronic Myeloid Leukemia - Chronic Phase	Hamad Medical Corporation	2017-08-03	PHASE3
NCT01667133	COMPLETED	Chronic Myeloid Leukemia (CML); Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)	Ariad Pharmaceuticals	2012-08-31	PHASE1; PHASE2
NCT00129740	COMPLETED	Leukemia, Myelogenous, Chronic	M.D. Anderson Cancer Center	2005-06-27	PHASE2
NCT02709083	TERMINATED	Chronic Myelogenous Leukemia; Chronic Myeloid Leukemia; Leukemia	Emory University	2016-10	PHASE2
NCT01804985	COMPLETED	Chronic Myeloid Leukaemia	University of Liverpool	2013-12	PHASE2
NCT00481052	COMPLETED	Chronic Myeloid Leukemia	Gruppo Italiano Malattie EMatologiche dell'Adulto	2007-06-23	PHASE2
NCT02253277	COMPLETED	Chronic Myeloid Leukemia	Novartis Pharmaceuticals	2015-02-18	PHASE1
NCT02389920	UNKNOWN	Leukemia, Chronic Myeloid	Samsung Medical Center	2015-04	PHASE4
NCT02774512	WITHDRAWN	Colon Cancer	Institut Bergonié	2016-05	EARLY_PHASE1
NCT01806571	COMPLETED	Untreated Adult Acute Myeloid Leukemia	Mayo Clinic	2015-03-12	PHASE2
NCT02891395	COMPLETED	Graft Versus Host Disease	University Hospital, Lille	2012-12-24	PHASE2
NCT02225574	TERMINATED	Leukemia	M.D. Anderson Cancer Center	2015-03-11	PHASE1
NCT02272777	COMPLETED	Leukemia	Novartis Pharmaceuticals	2014-07-17	PHASE3
NCT01605981	WITHDRAWN	Chronic Myeloid Leukemia (CML)	Novartis Pharmaceuticals	2014-02	PHASE4
NCT01395121	COMPLETED	Mucosal Lentiginous Melanoma; Acral Lentiginous Malignant Melanoma	Institute of Cancer Research, United Kingdom	2009-12	PHASE2
NCT01871311	TERMINATED	Colorectal Cancer; Head and Neck Cancer	Georgetown University	2014-05	PHASE1
NCT02115386	TERMINATED	Philadelphia Positive (Ph+) Chronic Myeloid Leukemia	Novartis Pharmaceuticals	2015-12-17	PHASE3
NCT03332511	COMPLETED	Chronic Myeloid Leukemia, Chronic Phase	Seoul National University Hospital	2013-05-06	PHASE4
NCT01702064	COMPLETED	Chronic Phase Chronic Myeloid Leukemia	H. Lee Moffitt Cancer Center and Research Institute	2013-02-21	PHASE1
NCT01140568	COMPLETED	Glioma	David Piccioni, M.D., Ph.D	2010-04-21	PHASE2
NCT02108951	TERMINATED	Philidelphia Positive Chronic Myeloid Leukaemia	Novartis Pharmaceuticals	2014-07-07	PHASE3
NCT02086487	TERMINATED	Myeloid Leukemia, Chronic	King Abdullah International Medical Research Center	2013-03	PHASE4
NCT01275586	COMPLETED	Neurofibromatosis; NF1; Neurofibromas	Indiana University	2011-01	EARLY_PHASE1
NCT01844765	COMPLETED	Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia	Novartis Pharmaceuticals	2013-08-20	PHASE2
NCT01784068	COMPLETED	Chronic Myelogenous Leukemia	Novartis Pharmaceuticals	2013-03-19	PHASE2
NCT01866553	TERMINATED	Chronic Myeloid Leukemia	Amsterdam UMC, location VUmc	2013-04	PHASE2
NCT00750659	COMPLETED	Chronic Myeloid Leukemia; Acute Lymphoblastic Leukemia; Stem Cell Transplantation	Sheba Medical Center	2009-07	PHASE2
NCT01407198	COMPLETED	Chordoma	Massachusetts General Hospital	2011-08	PHASE1
NCT01025505	COMPLETED	Treatment; Stem Cell Transplantation	Gruppo Italiano Malattie EMatologiche dell'Adulto	2012-06	PHASE2
NCT02587169	UNKNOWN	Retroperitoneal Liposarcoma; Retroperitoneal Leiomyosarcoma; Chondrosarcoma	Broto, Javier Martín, M.D.	2012-01	PHASE1; PHASE2
NCT01698905	COMPLETED	Chronic Myeloid Leukemia	Novartis Pharmaceuticals	2012-12-20	PHASE2
NCT01884922	COMPLETED	Refractory Low-grade Gliomas; Recurrent Low-grade Gliomas	Gustave Roussy, Cancer Campus, Grand Paris	2013-05-29	PHASE1
NCT01670084	WITHDRAWN	B-cell Adult Acute Lymphoblastic Leukemia; Blastic Phase Chronic Myelogenous Leukemia; Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia; Untreated Adult Acute Lymphoblastic Leukemia	Mayo Clinic	2012-12	PHASE2
NCT01077544	COMPLETED	Chronic Myeloid Leukemia; Acute Lymphoblastic Leukemia	Novartis Pharmaceuticals	2011-04-14	PHASE1
NCT00760877	COMPLETED	CHRONIC MYELOGENOUS LEUKEMIA	Novartis Pharmaceuticals	2009-06	PHASE3
NCT02281474	COMPLETED	Parkinson's Disease; Parkinson's Disease Dementia; Diffuse Lewy Body Disease	Georgetown University	2014-11	PHASE1
NCT01222143	TERMINATED	Acute Myeloid Leukemia	University Health Network, Toronto	2010-10	PHASE1; PHASE2
NCT01490775	TERMINATED	Chronic Phase CML	Rex Cancer Center, Raleigh, NC	2009-04
NCT01810718	COMPLETED	Chronic Graft Versus Host Disease	Gruppo Italiano Trapianto di Midollo Osseo	2011-11	PHASE1
NCT01028222	COMPLETED	Melanoma	Novartis Pharmaceuticals	2010-06	PHASE2
NCT01254188	COMPLETED	Chronic Myeloid Leukemia	Novartis Pharmaceuticals	2011-04	PHASE3
NCT01535391	COMPLETED	Chronic Myeloid Leukemia	Gruppo Italiano Malattie EMatologiche dell'Adulto	2012-01	PHASE3
NCT01227577	COMPLETED	Chronic Myelogenous Leukemia in Chronic Phase	Novartis Pharmaceuticals	2010-11	PHASE4
NCT01275196	COMPLETED	Chronic Myeloid Leukemia	Novartis Pharmaceuticals	2011-04	PHASE3
NCT00769327	COMPLETED	Leukemia	Gruppo Italiano Malattie EMatologiche dell'Adulto	2009-02-09	PHASE2
NCT01490983	TERMINATED	Chronic Myeloid Leukemia	Rex Cancer Center, Raleigh, NC	2009-04
NCT00785785	COMPLETED	Gastrointestinal Stromal Tumor (GIST)	Novartis Pharmaceuticals	2009-03	PHASE3
NCT00036738	COMPLETED	Adult Acute Lymphoblastic Leukemia in Remission; Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1; 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; Chronic Phase of Disease; Recurrent Adult Acute Lymphoblastic Leukemia; Recurrent Childhood Acute Lymphoblastic Leukemia; Recurrent Disease	Fred Hutchinson Cancer Center	2001-07-13	PHASE2
NCT01166139	COMPLETED	Systemic Sclerosis	Hospital for Special Surgery, New York	2010-07	PHASE2
NCT01061177	COMPLETED	CML in Chronic Phase	Novartis Pharmaceuticals	2010-05	PHASE4
NCT00802841	COMPLETED	Chronic Myelogenous Leukemia	Novartis Pharmaceuticals	2009-05	PHASE3
NCT01289028	COMPLETED	Gastrointestinal Stromal Tumors	Novartis Pharmaceuticals	2008-11	PHASE3
NCT01400074	UNKNOWN	Chronic Myeloid Leukemia	Seoul St. Mary's Hospital	2009-01	PHASE3
NCT01207492	COMPLETED	Pigmented Villonodular Synovitis; Diffuse-type Giant Cell Tumor; Tenosynovial Giant Cell Tumor	Andrew J. Wagner, MD, PhD	2010-09	PHASE2
NCT01456676	COMPLETED	Philadelphia Chromosome Positive Chronic Myelogenous Leukemia	Novartis Pharmaceuticals	2012-01	PHASE1
NCT01220648	COMPLETED	Chronic Myeloid Leukemia	Novartis Pharmaceuticals	2012-04	PHASE1
NCT01099514	COMPLETED	Metastatic Melanoma With KIT Aberration	Samsung Medical Center	2009-08	PHASE2
NCT00702403	COMPLETED	Accelerated Phase Chronic Myelogenous Leukemia; Adult Acute Lymphoblastic Leukemia in Remission; Blastic Phase Chronic Myelogenous Leukemia; Childhood Acute Lymphoblastic Leukemia in Remission; Childhood Chronic Myelogenous Leukemia; Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Chronic Phase Chronic Myelogenous Leukemia; Philadelphia Positive Adult Acute Lymphoblastic Leukemia; Philadelphia Positive Childhood Acute Lymphoblastic Leukemia; Recurrent Adult Acute Lymphoblastic Leukemia; Recurrent Childhood Acute Lymphoblastic Leukemia; Relapsing Chronic Myelogenous Leukemia; Untreated Adult Acute Lymphoblastic Leukemia; Untreated Childhood Acute Lymphoblastic Leukemia	Fred Hutchinson Cancer Center	2008-08-14	PHASE1; PHASE2
NCT01168050	UNKNOWN	Malignant Skin Melanoma T0; Stage III Melanoma; Stage IV Melanoma; Amplification	Assistance Publique - Hôpitaux de Paris	2010-07	PHASE2
NCT01043874	COMPLETED	Philadelphia Chromosome Positive; Chronic Myelogenous Leukemia in Chronic Phase	Novartis Pharmaceuticals	2009-12	PHASE4
NCT01155817	COMPLETED	Bone Marrow Transplant Failure; Lymphoma, Non-Hodgkin; Lymphoma, T-Cell, Peripheral	Stanford University	2010-08	PHASE1
NCT01223898	COMPLETED	Chronic Myeloid Leukemia	Novartis Pharmaceuticals	2010-06	PHASE1
NCT01252017	COMPLETED	Patients Who Have Received Allo-HSCT	National Taiwan University Hospital	2010-11	PHASE2
NCT01819389	COMPLETED	Leukemia, Myeloid, Chronic, BCR-ABL Positive	Hospital Universitario Dr. Jose E. Gonzalez	2012-10	PHASE3
NCT00718562	COMPLETED	Gastrointestinal Stromal Tumors	Novartis Pharmaceuticals	2008-09	PHASE2
NCT01261429	COMPLETED	Pigmented Villonodular Synovitis	Centre Leon Berard	2010-12	PHASE2
NCT01169753	TERMINATED	Chronic Myeloid Leukemia	M.D. Anderson Cancer Center	2011-05
NCT01179737	TERMINATED	Pulmonary Arterial Hypertension	Novartis Pharmaceuticals	2010-07	PHASE2
NCT00980018	COMPLETED	Chronic Myelogenous Leukemia	Novartis Pharmaceuticals	2009-12	PHASE4
NCT01602952	COMPLETED	Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Philadelphia Chromosome; Hematologic Diseases	Il-Yang Pharm. Co., Ltd.	2008-07	PHASE1; PHASE2
NCT01206088	COMPLETED	CML; Nilotinib; Imatinib Resistant; Imatinib Intolerant	Novartis Pharmaceuticals	2009-02	PHASE4
NCT00109707	COMPLETED	Chronic Myelogenous Leukemia; Acute Lymphoblastic Leukemia (Philadelphia Chromosome Positive); Hypereosinophilic Syndrome; Systemic Mastocytosis	Novartis Pharmaceuticals	2005-04	PHASE1; PHASE2
NCT00751036	TERMINATED	Gastrointestinal Stromal Tumors	Novartis Pharmaceuticals	2009-06	PHASE3
NCT00905398	TERMINATED	Precursor B-Cell Lymphoblastic Leukemia-Lymphoma; Acute Lymphoblastic Leukemia	Rony Schaffel	2009-05	PHASE1; PHASE2
NCT00844298	COMPLETED	Leukemia	Asan Medical Center	2009-01	PHASE2
NCT00762632	COMPLETED	Acute Myeloid Leukemia	Technical University of Munich	2007-12	PHASE1; PHASE2
NCT00644878	TERMINATED	Chronic Myelogenous Leukemia - Chronic Phase	Novartis Pharmaceuticals	2008-10	PHASE2
NCT00786812	COMPLETED	Chronic Myeloid Leukemia	Novartis Pharmaceuticals	2008-08	PHASE4
NCT01089595	TERMINATED	GIST; Metastatic Disease	Fox Chase Cancer Center	2009-02	PHASE2
NCT01201538	TERMINATED	Growing Vestibular Schwannomas	University Health Network, Toronto	2010-10	PHASE2
NCT01110668	COMPLETED	Gastrointestinal Stromal Tumor	Novartis Pharmaceuticals	2008-09	PHASE2
NCT00732888	COMPLETED	Healthy	Jan Beumer	2008-11	PHASE1
NCT01131325	TERMINATED	CML; Philadelphia Chromosome Positive (Ph+); Chronic Myelogenous Leukemia Chronic Phase(CML-CP) Patients With Low Imatinib Trough Levels	Novartis Pharmaceuticals	2010-10-21	PHASE4
NCT00809211	COMPLETED	Leukemia	Cancer Trials Ireland	2008-10	PHASE2
NCT00788775	COMPLETED	Mucosal Lentiginous Melanoma; Acral Melanoma; Melanoma	Dana-Farber Cancer Institute	2009-01-23	PHASE2
NCT01126892	COMPLETED	Chronic Myeloid Leukemia	Novartis Pharmaceuticals	2009-01	PHASE3
NCT01294618	COMPLETED	Chronic Myelogenous Leukemia	Hospices Civils de Lyon	2011-03	PHASE2
NCT00441155	COMPLETED	Gastrointestinal Stromal Tumors	Novartis Pharmaceuticals	2006-11	PHASE1
NCT00573378	TERMINATED	Chronic Myeloid Leukemia	University of Michigan Rogel Cancer Center	2007-09	PHASE2
NCT00633295	COMPLETED	Gastrointestinal Stromal Tumors (GIST)	Novartis Pharmaceuticals	2008-06	PHASE2
NCT01368523	COMPLETED	Chronic Myelogenous Leukemia	Novartis Pharmaceuticals	2008-12	PHASE4
NCT01279473	COMPLETED	Chronic Myelogenous Leukemia; Acute Lymphoblastic Leukemia	Novartis Pharmaceuticals	2005-08	PHASE1; PHASE2
NCT00471497	COMPLETED	Myelogenous Leukemia, Chronic	Novartis Pharmaceuticals	2007-07-31	PHASE3
NCT00519090	TERMINATED	Myelogenous Leukemia	Novartis Pharmaceuticals	2007-10	PHASE3
NCT00471328	COMPLETED	Gastrointestinal Stromal Tumors	Novartis Pharmaceuticals	2007-03	PHASE3
NCT00782834	TERMINATED	Gastrointestinal Stromal Tumors	Fox Chase Cancer Center	2008-07	PHASE2
NCT00418626	COMPLETED	Healthy	Novartis Pharmaceuticals	2006-11	PHASE1
NCT00384228	COMPLETED	Chronic Myelogenous Leukemia; Acute Lymphoblastic Leukemia (Philadelphia Chromosome Positive)	Novartis Pharmaceuticals	2005-05	PHASE1; PHASE2
NCT00418756	COMPLETED	Healthy	Novartis Pharmaceuticals	2006-10	PHASE1
NCT00418769	COMPLETED	Healthy	Novartis Pharmaceuticals	2006-06	PHASE1
NCT01270893	WITHDRAWN	Gastrointestinal Cancer	M.D. Anderson Cancer Center	2011-01	PHASE2

(data from https://clinicaltrials.gov, updated on 2026-03-25)

Check the Nilotinib (AMN-107) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Nilotinib selectively binds to the catalytic ATP-binding domain of the BCR-ABL tyrosine kinase, inhibiting its autophosphorylation and downstream oncogenic signaling pathways to suppress cellular proliferation and induce apoptosis. By suppressing BCR-ABL-driven kinase activity, nilotinib halts malignant cell expansion, providing the mechanistic rationale for its clinical evaluation in chronic myeloid leukemia, Philadelphia chromosome-positive acute lymphoblastic leukemia, and advanced solid tumors.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).