Nilotinib
Information
- Drug Name
- Nilotinib
- Description
- Entry(CIViC)
- 39
CIViC
Annotation
| Description | Associated Genes | Associated Variants | Sensitivity | Supported | Source | Links |
|---|---|---|---|---|---|---|
| In an in vitro study, a Ba/F3 cell line stably ex... | ABL1 |
ABL1 p.Phe378Val (p.F378V) ( ENST00000318560.6, ENST00000372348.9 ) ABL1 p.Phe378Val (p.F378V) ( ENST00000318560.6, ENST00000372348.9 ) |
Resitance or Non-Reponse | true | CIViC Evidence | detail |
| The use of nilotinib and dasatinib, second-generat... | ABL1 | ABL1 BCR-ABL | Sensitivity | true | CIViC Evidence | detail |
| In an in vitro study, a Ba/F3-p210BCR-ABL1 cell li... | ABL1 |
ABL1 p.Leu267Val (p.L267V) ( ENST00000318560.6, ENST00000372348.9 ) ABL1 p.Leu267Val (p.L267V) ( ENST00000318560.6, ENST00000372348.9 ) |
Resitance or Non-Reponse | true | CIViC Evidence | detail |
| In an in vitro study, a Ba/F3 cell line stably exp... | ABL1 |
ABL1 p.Gly269Glu (p.G269E) ( ENST00000318560.6, ENST00000372348.9 ) ABL1 p.Gly269Glu (p.G269E) ( ENST00000318560.6, ENST00000372348.9 ) |
Resitance or Non-Reponse | true | CIViC Evidence | detail |
| In an in vitro study, a Ba/F3-p210BCR-ABL1 cell li... | ABL1 |
ABL1 p.Tyr272His (p.Y272H) ( ENST00000318560.6, ENST00000372348.9 ) ABL1 p.Tyr272His (p.Y272H) ( ENST00000318560.6, ENST00000372348.9 ) |
Resitance or Non-Reponse | true | CIViC Evidence | detail |
| In an in vitro study, Ba/F3 cell line stably expre... | ABL1 | ABL1 p.Glu274Lys (p.E274K) ABL1 p.Glu274Lys (p.E274K) | Resitance or Non-Reponse | true | CIViC Evidence | detail |
| In an in vitro study, a Ba/F3 cell line stably ex... | ABL1 |
ABL1 p.Asp295Gly (p.D295G) ( ENST00000318560.6, ENST00000372348.9 ) ABL1 p.Asp295Gly (p.D295G) ( ENST00000318560.6, ENST00000372348.9 ) |
Sensitivity | true | CIViC Evidence | detail |
| In an in vitro study, a Ba/F3 cell line stably ex... | ABL1 | ABL1 p.Thr334Ile (p.T334I) ABL1 p.Thr334Ile (p.T334I) | Resitance or Non-Reponse | true | CIViC Evidence | detail |
| In an in vitro study, a Ba/F3 cell line stably exp... | ABL1 | ABL1 p.Phe336Leu (p.F336L) ABL1 p.Phe336Leu (p.F336L) | Resitance or Non-Reponse | false | CIViC Evidence | detail |
| In an in vitro study, Ba/F3 cell line stably expre... | ABL1 |
ABL1 p.Met370Thr (p.M370T) ( ENST00000318560.6, ENST00000372348.9 ) ABL1 p.Met370Thr (p.M370T) ( ENST00000318560.6, ENST00000372348.9 ) |
Sensitivity | true | CIViC Evidence | detail |
| In an in vitro study, a Ba/F3 cell line stably exp... | ABL1 | ABL1 p.Phe505Ser (p.F505S) ABL1 p.Phe505Ser (p.F505S) | Sensitivity | true | CIViC Evidence | detail |
| In an in vitro study, a Ba/F3 cell line stably ex... | ABL1 |
ABL1 p.Glu274Val (p.E274V) ( ENST00000318560.6, ENST00000372348.9 ) ABL1 p.Glu274Val (p.E274V) ( ENST00000318560.6, ENST00000372348.9 ) |
Resitance or Non-Reponse | true | CIViC Evidence | detail |
| In an in vitro study, a Ba/F3-p210BCR-ABL1 cell li... | ABL1 |
ABL1 p.Glu274Val (p.E274V) ( ENST00000318560.6, ENST00000372348.9 ) ABL1 p.Glu274Val (p.E274V) ( ENST00000318560.6, ENST00000372348.9 ) |
Resitance or Non-Reponse | true | CIViC Evidence | detail |
| In an in vitro study, a Ba/F3-p210BCR-ABL1 cell li... | ABL1 |
ABL1 p.Glu311Val (p.E311V) ( ENST00000318560.6, ENST00000372348.9 ) ABL1 p.Glu311Val (p.E311V) ( ENST00000318560.6, ENST00000372348.9 ) |
Resitance or Non-Reponse | true | CIViC Evidence | detail |
| In an in vitro study, a Ba/F3-p210BCR-ABL1 cell li... | ABL1 |
ABL1 p.Phe378Cys (p.F378C) ( ENST00000318560.6, ENST00000372348.9 ) ABL1 p.Phe378Cys (p.F378C) ( ENST00000318560.6, ENST00000372348.9 ) |
Resitance or Non-Reponse | true | CIViC Evidence | detail |
| In an in vitro study, a Ba/F3-p210BCR-ABL1 cell li... | ABL1 |
ABL1 p.Leu403Met (p.L403M) ( ENST00000318560.6, ENST00000372348.9 ) ABL1 p.Leu403Met (p.L403M) ( ENST00000318560.6, ENST00000372348.9 ) |
Resitance or Non-Reponse | true | CIViC Evidence | detail |
| In an in vitro study, a Ba/F3 cell line stably exp... | ABL1 |
ABL1 p.Val318Leu (p.V318L) ( ENST00000318560.6, ENST00000372348.9 ) ABL1 p.Val318Leu (p.V318L) ( ENST00000318560.6, ENST00000372348.9 ) |
Sensitivity | true | CIViC Evidence | detail |
| In an in vitro study, a Ba/F3-p210BCR-ABL1 cell li... | ABL1 |
ABL1 p.Leu406Phe (p.L406F) ( ENST00000318560.6, ENST00000372348.9 ) ABL1 p.Leu406Phe (p.L406F) ( ENST00000318560.6, ENST00000372348.9 ) |
Resitance or Non-Reponse | true | CIViC Evidence | detail |
| In an in vitro study, a Ba/F3 cell line stably exp... | ABL1 | ABL1 p.Gly417Arg (p.G417R) ABL1 p.Gly417Arg (p.G417R) | Sensitivity | true | CIViC Evidence | detail |
| Ba/F3 cells harboring the KIT L576P mutation are s... | KIT |
KIT p.Leu577Pro (p.L577P) ( ENST00000288135.6, ENST00000412167.7, ENST00000686011.1, ENST00000687109.1, ENST00000687246.1, ENST00000687295.1, ENST00000689832.1, ENST00000689994.1, ENST00000690543.1, ENST00000692783.1 ) KIT p.Leu577Pro (p.L577P) ( ENST00000288135.6, ENST00000412167.7, ENST00000686011.1, ENST00000687109.1, ENST00000687246.1, ENST00000687295.1, ENST00000689832.1, ENST00000689994.1, ENST00000690543.1, ENST00000692783.1 ) |
Sensitivity | true | CIViC Evidence | detail |
| The melanoma cell line WM3211, which harbors the L... | KIT |
KIT p.Leu577Pro (p.L577P) ( ENST00000288135.6, ENST00000412167.7, ENST00000686011.1, ENST00000687109.1, ENST00000687246.1, ENST00000687295.1, ENST00000689832.1, ENST00000689994.1, ENST00000690543.1, ENST00000692783.1 ) KIT p.Leu577Pro (p.L577P) ( ENST00000288135.6, ENST00000412167.7, ENST00000686011.1, ENST00000687109.1, ENST00000687246.1, ENST00000687295.1, ENST00000689832.1, ENST00000689994.1, ENST00000690543.1, ENST00000692783.1 ) |
Resitance or Non-Reponse | true | CIViC Evidence | detail |
| In an in vitro study, stochastic mutations were in... | ABL1 | ABL1 p.Glu274Lys (p.E274K) ABL1 p.Glu274Lys (p.E274K) | Resitance or Non-Reponse | true | CIViC Evidence | detail |
| In an in vitro study, stochastic mutations were in... | ABL1 | ABL1 p.Thr334Ile (p.T334I) ABL1 p.Thr334Ile (p.T334I) | Resitance or Non-Reponse | true | CIViC Evidence | detail |
| In this open-label, phase II registration trial, p... | ABL1 |
ABL1 p.Tyr272His (p.Y272H) ( ENST00000318560.6, ENST00000372348.9 ) ABL1 p.Tyr272His (p.Y272H) ( ENST00000318560.6, ENST00000372348.9 ) |
Resitance or Non-Reponse | true | CIViC Evidence | detail |
| In this open-label, phase II registration trial, p... | ABL1 | ABL1 p.Glu274Lys (p.E274K) ABL1 p.Glu274Lys (p.E274K) | Resitance or Non-Reponse | true | CIViC Evidence | detail |
| In this open-label, phase II registration trial, p... | ABL1 |
ABL1 p.Phe378Cys (p.F378C) ( ENST00000318560.6, ENST00000372348.9 ) ABL1 p.Phe378Cys (p.F378C) ( ENST00000318560.6, ENST00000372348.9 ) |
Resitance or Non-Reponse | true | CIViC Evidence | detail |
| In an in vitro study, stochastic mutations were in... | ABL1 | ABL1 p.Thr334Ile (p.T334I) ABL1 p.Thr334Ile (p.T334I) | Resitance or Non-Reponse | true | CIViC Evidence | detail |
| In an in vitro study, stochastic mutations were in... | ABL1 |
ABL1 p.Leu267Val (p.L267V) ( ENST00000318560.6, ENST00000372348.9 ) ABL1 p.Leu267Val (p.L267V) ( ENST00000318560.6, ENST00000372348.9 ) |
Resitance or Non-Reponse | true | CIViC Evidence | detail |
| In an in vitro study, stochastic mutations were in... | ABL1 |
ABL1 p.Tyr272His (p.Y272H) ( ENST00000318560.6, ENST00000372348.9 ) ABL1 p.Tyr272His (p.Y272H) ( ENST00000318560.6, ENST00000372348.9 ) |
Resitance or Non-Reponse | true | CIViC Evidence | detail |
| In an in vitro study, stochastic mutations were in... | ABL1 |
ABL1 p.Phe330Leu (p.F330L) ( ENST00000318560.6, ENST00000372348.9 ) ABL1 p.Phe330Leu (p.F330L) ( ENST00000318560.6, ENST00000372348.9 ) |
Resitance or Non-Reponse | true | CIViC Evidence | detail |
| In an in vitro study, stochastic mutations were in... | ABL1 |
ABL1 p.Phe378Cys (p.F378C) ( ENST00000318560.6, ENST00000372348.9 ) ABL1 p.Phe378Cys (p.F378C) ( ENST00000318560.6, ENST00000372348.9 ) |
Resitance or Non-Reponse | true | CIViC Evidence | detail |
| In an in vitro study, stochastic mutations were in... | ABL1 |
ABL1 p.His415Pro (p.H415P) ( ENST00000318560.6, ENST00000372348.9 ) ABL1 p.His415Pro (p.H415P) ( ENST00000318560.6, ENST00000372348.9 ) |
Resitance or Non-Reponse | true | CIViC Evidence | detail |
| In an in vitro study, stochastic mutations were in... | ABL1 |
ABL1 p.Gly269Glu (p.G269E) ( ENST00000318560.6, ENST00000372348.9 ) ABL1 p.Gly269Glu (p.G269E) ( ENST00000318560.6, ENST00000372348.9 ) |
Resitance or Non-Reponse | true | CIViC Evidence | detail |
| In an in vitro study, stochastic mutations were in... | ABL1 | ABL1 p.Thr334Ile (p.T334I) ABL1 p.Thr334Ile (p.T334I) | Resitance or Non-Reponse | true | CIViC Evidence | detail |
| In this open-label, phase II registration trial, p... | ABL1 | ABL1 MUTATION ABL1 MUTATION | Resitance or Non-Reponse | false | CIViC Evidence | detail |
| In this open-label, phase II registration trial, p... | ABL1 |
ABL1 p.Phe378Val (p.F378V) ( ENST00000318560.6, ENST00000372348.9 ) ABL1 p.Phe378Val (p.F378V) ( ENST00000318560.6, ENST00000372348.9 ) |
Resitance or Non-Reponse | true | CIViC Evidence | detail |
| In this open-label, phase II registration trial, p... | ABL1 |
ABL1 p.Glu274Val (p.E274V) ( ENST00000318560.6, ENST00000372348.9 ) ABL1 p.Glu274Val (p.E274V) ( ENST00000318560.6, ENST00000372348.9 ) |
Resitance or Non-Reponse | true | CIViC Evidence | detail |
| Bone marrow mononuclear cells (BM MNCs) isolated f... | ABL1 | ABL1 p.Thr334Ile (p.T334I) ABL1 p.Thr334Ile (p.T334I) | Resitance or Non-Reponse | true | CIViC Evidence | detail |
| Bone marrow mononuclear cells (BM MNCs) were isola... | ABL1 | ABL1 p.Thr334Ile (p.T334I) ABL1 p.Thr334Ile (p.T334I) | Resitance or Non-Reponse | true | CIViC Evidence | detail |
| In vitro testing showed that the cell viability of... | KIT | KIT L576P | Resitance or Non-Reponse | true | MMMP | detail |
| NCT ID | Status | Phase | Summary | Start date | Completion date |
|---|---|---|---|---|---|
| NCT01207492 | Active, not recruiting | Phase 2 | Nilotinib in Patients With Relapsed or Metastatic Pigmented Villonodular Synovitis/Tenosynovial Giant Cell Tumor/Diffuse-Type Giant Cell Tumor | September 2010 | January 2025 |
| NCT03654768 | Active, not recruiting | Phase 2 | Testing the Addition of Ruxolitinib to the Usual Treatment (Tyrosine Kinase Inhibitors) for Chronic Myeloid Leukemia | October 24, 2018 | July 1, 2028 |
| NCT03874858 | Active, not recruiting | Phase 2 | De-escalation and TFR Study in CML Patients Treated With Nilotinib Followed by a Second Attempt After Nilotinib and Asciminib Combination | March 22, 2019 | December 31, 2026 |
| NCT00756509 | Active, not recruiting | Phase 4 | Treatment of Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumors in First Line With Nilotinib | August 29, 2008 | December 31, 2024 |
| NCT04971226 | Active, not recruiting | Phase 3 | A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP | October 6, 2021 | January 18, 2028 |
| NCT03578367 | Active, not recruiting | Phase 2 | Study of Efficacy and Safety of Asciminib in Combination With Imatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CML-CP) | November 22, 2018 | February 6, 2025 |
| NCT04578847 | Active, not recruiting | Phase 2 | A Study of REduction And DIscontinuation Treatment of TKI (Imatinib, Nilotinib, Dasatinib and Bosutinib) | January 15, 2020 | January 15, 2025 |
| NCT04147533 | Active, not recruiting | Phase 2 | Efficacy and Safety of TKIs' Withdrawal After a Two-step Dose Reduction in Patients With Chronic Myeloid Leukemia | June 16, 2020 | June 2026 |
| NCT02917720 | Active, not recruiting | Phase 2 | 2nd or 3rd TKI-stop After 2 Years Nilotinib Pre-treatment in CML-patients | September 2016 | September 2027 |
| NCT01698905 | Active, not recruiting | Phase 2 | Treatment-free Remission After Achieving Sustained MR4.5 on Nilotinib (ENESTop) | December 20, 2012 | January 24, 2025 |
| NCT01407198 | Active, not recruiting | Phase 1 | Nilotinib With Radiation for High Risk Chordoma | August 2011 | December 2025 |
| NCT03784014 | Active, not recruiting | Phase 3 | Molecular Profiling of Advanced Soft-tissue Sarcomas | October 19, 2019 | October 2025 |
| NCT00905593 | Approved for marketing | Nilotinib in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase | September 2008 | ||
| NCT00762632 | Completed | Phase 1/Phase 2 | Combination of Nilotinib (AMN107) and RAD001 in Patients With Acute Myeloid Leukemia | December 2007 | |
| NCT00769327 | Completed | Phase 2 | Nilotinib and Imatinib Mesylate in Treating Patients With Early Chronic Phase Chronic Myelogenous Leukemia | February 9, 2009 | October 10, 2014 |
| NCT00786812 | Completed | Phase 4 | Study of Treatment With Nilotinib in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase | August 2008 | January 2012 |
| NCT00788775 | Completed | Phase 2 | Nilotinib in TKI Resistant or Intolerant Patients With Metastatic Mucosal, Acral, or Chronically Sun Damaged Melanoma | January 23, 2009 | March 2014 |
| NCT00802841 | Completed | Phase 3 | Randomized Phase Lll Study of Imatinib Dose Optimization vs Nilotinib in CML Patients With Suboptimal Response to Imatinib | May 2009 | July 2014 |
| NCT00809211 | Completed | Phase 2 | Nilotinib in Treating Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia | October 2008 | February 2016 |
| NCT00976612 | Completed | Nilotinib Pharmacokinetics (PK) in Gastrointestinal Stromal Tumor (GIST): Nilotinib PK | January 2009 | December 2011 | |
| NCT00980018 | Completed | Phase 4 | An Exploratory Trial to Assess the Improvement of Adverse Events in Chronic Myelogenous Leukemia Patients Treated With Imatinib When Switched to Nilotinib Treatment | December 2009 | December 2012 |
| NCT01025505 | Completed | Phase 2 | Ph+/Bcr-Abl+ ALL Imatinib and Nilotinib Rotational Study | June 2012 | September 1, 2020 |
| NCT01028222 | Completed | Phase 2 | A Study of AMNN107 in the Treatment of Metastatic and/or Inoperable Melanoma Harboring a c-Kit Mutation | June 2010 | December 2014 |
| NCT00036738 | Completed | Phase 2 | 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 | July 13, 2001 | May 2018 |
| NCT01061177 | Completed | Phase 4 | Nilotinib in Newly Diagnosed Adult Philadelphia Chromosome & /or BCR-ABL Positive Chronic Myeloid Leukaemia in Chronic Phase | May 2010 | July 2014 |
| NCT01077544 | Completed | Phase 1 | A Pharmacokinetic (PK) Study of Nilotinib in Pediatric Patients With Philadelphia Chromosome-positive (Ph+) Chronic Myelogenous Leukemia (CML) or Acute Lymphoblastic Leukemia (ALL) | April 14, 2011 | July 1, 2015 |
| NCT01099514 | Completed | Phase 2 | Study of Nilotinib in Metastatic Melanoma With KIT Aberrations | August 2009 | June 2015 |
| NCT01110668 | Completed | Phase 2 | Evaluation of Nilotinib In Patients With Advanced Gastrointestinal Stromal Tumor (GIST) | September 2008 | September 2011 |
| NCT01126892 | Completed | Phase 3 | A Study of Nilotinib in Adult Patients With Imatinib Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase | January 2009 | April 2011 |
| NCT01140568 | Completed | Phase 2 | Study of Platelet Derived Growth Factor Receptor (PDGFR) in Recurrent Malignant Gliomas | April 21, 2010 | January 2019 |
| NCT01155817 | Completed | Phase 1 | Phase 1 Nilotinib in Steroid Dependent/Refractory Chronic Graft Versus Host Disease | August 2010 | December 2013 |
| NCT01206088 | Completed | Phase 4 | Tasigna in Glivec-resistant or Intolerant Patients in CML | February 2009 | September 2012 |
| NCT01043874 | Completed | Phase 4 | Study to Evaluate Nilotinib in Chronic Myelogenous Leukemia (CML) Patients With SubOptimal Response | December 2009 | January 2014 |
| NCT00109707 | Completed | Phase 1/Phase 2 | A Study of Oral AMN107 in Adults With Chronic Myelogenous Leukemia (CML) or Other Hematologic Malignancies | April 2005 | September 2012 |
| NCT00129740 | Completed | Phase 2 | Phase II Nilotinib With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML) | June 27, 2005 | July 11, 2018 |
| NCT00384228 | Completed | Phase 1/Phase 2 | A Phase l/ll Study of AMN107 in Adult Patients With Glivec-intolerant CML or Relapsed-refractory Ph+ALL | May 2005 | |
| NCT00418626 | Completed | Phase 1 | Pharmacokinetics of Nilotinib in Subjects With Impaired Hepatic Function and Healthy Subjects With Normal Hepatic Function | November 2006 | |
| NCT00418756 | Completed | Phase 1 | Effects of Rifampin on the Pharmacokinetics of Nilotinib in Healthy Subjects | October 2006 | |
| NCT00418769 | Completed | Phase 1 | Bioavailability Study Comparing Two New Nilotinib Tablet Formulations to an Established Nilotinib Capsule Formulation in Healthy Volunteers | June 2006 | |
| NCT00471328 | Completed | Phase 3 | Efficacy and Safety of Nilotinib (AMN107) Compared With Current Treatment Options in Patients With GIST Who Have Failed Both Imatinib and Sunitinib | March 2007 | June 2011 |
| NCT00471497 | Completed | Phase 3 | A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) | July 31, 2007 | August 21, 2019 |
| NCT00481052 | Completed | Phase 2 | Nilotinib as First-line Treatment of Ph+ CML in Early Chronic Phase | June 23, 2007 | April 30, 2018 |
| NCT00702403 | Completed | Phase 1/Phase 2 | Nilotinib and Imatinib Mesylate After Donor Stem Cell Transplant in Treating Patients With ALL or CML | August 14, 2008 | December 1, 2013 |
| NCT00750659 | Completed | Phase 2 | Nilotinib Pre and Post Allogeneic Stem Cell Transplantation | July 2009 | April 2016 |
| NCT00760877 | Completed | Phase 3 | Nilotinib Versus Standard Imatinib (400/600 mg Every Day (QD)) Comparing the Kinetics of Complete Molecular Response for Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Pts With Evidence of Persistent Leukemia by Real-time Quantitative Polymerase Chain Reaction (RQ-PCR) | June 2009 | July 2015 |
| NCT01227577 | Completed | Phase 4 | CMR Rate of Newly Diagnosed CML-CP Patients Treated With Nilotinib | November 2010 | November 2014 |
| NCT01252017 | Completed | Phase 2 | Nilotinib for Cytomegalovirus Prophylaxis and Treatment After Allogeneic Hematopoietic Stem Cell Transplantation | November 2010 | November 2014 |
| NCT01254188 | Completed | Phase 3 | Safety and Efficacy of Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia Patients | April 2011 | November 2014 |
| NCT01274351 | Completed | Phase 2 | Study of Nilotinib as First Line Treatment in Philadelphia Chromosome Positive(Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) | January 25, 2011 | August 1, 2019 |
| NCT01275196 | Completed | Phase 3 | Safety and Efficacy of Nilotinib vs. Imatinib in the Treatment of Newly Diagnosed Chinese Ph+ CML-CP Patients | April 2011 | October 2014 |
| NCT01279473 | Completed | Phase 1/Phase 2 | Study to Evaluate Nilotinib in Adult Patients With Imatinib-resistant or Imatinib-intolerant Chronic Myelogenous Leukemia (CML), or Relapse/Refractory Ph+ Acute Lymphoblastic Leukemia (ALL) (Extension Study) | August 2005 | |
| NCT01289028 | Completed | Phase 3 | Efficacy of Nilotinib in Adult Patients With Gastrointestinal Stromal Tumors Resistant to Imatinib and Sunitinib. | November 2008 | July 2014 |
| NCT01368523 | Completed | Phase 4 | Study of Oral AMN107 (Nilotinib) in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase Previously Enrolled to CAMN107A2109 Trial | December 2008 | |
| NCT01395121 | Completed | Phase 2 | A Trial Looking at Nilotinib to Treat Acral and Mucosal Melanoma Skin Cancer That Has Spread | December 2009 | December 12, 2016 |
| NCT01528085 | Completed | Phase 2 | Evaluation of Efficacy and Safety of Nilotinib in Combination With Chemotherapy in Elderly Patients With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia | January 2012 | March 10, 2020 |
| NCT01535391 | Completed | Phase 3 | Nilotinib in PH+, BCR-, ABL+ CML Patients | January 2012 | April 27, 2018 |
| NCT01657604 | Completed | Phase 3 | TKI and Interferon Alpha Evaluation Initiated by the German Chronic Myeloid Leukemia Study Group - the TIGER Study | August 24, 2012 | May 31, 2022 |
| NCT01702064 | Completed | Phase 1 | Ruxolitinib in Combination With Nilotinib in Chronic Myeloid Leukemia (CML) Patients | February 21, 2013 | January 9, 2019 |
| NCT01735955 | Completed | Phase 4 | Study to Allow Access to Nilotinib for Patients Who Are on Nilotinib Treatment in a Novartis-sponsored Study | March 29, 2013 | July 7, 2023 |
| NCT01743989 | Completed | Phase 3 | A Randomized Phase III Study to Assess the Effect of a Longer Duration of Consolidation Treatment With Nilotinib on TFR in CP CML. | April 15, 2013 | July 8, 2020 |
| NCT01744665 | Completed | Phase 2 | A Study That Switched Patients From Imatinib to Nilotinib and Then Was Followed by Treatment Cessation | August 12, 2013 | September 29, 2018 |
| NCT01774630 | Completed | Phase 2 | 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) | April 10, 2013 | December 21, 2020 |
| NCT01806571 | Completed | Phase 2 | Daunorubicin Hydrochloride, Cytarabine, and Nilotinib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia | March 12, 2015 | November 30, 2019 |
| NCT01810718 | Completed | Phase 1 | Phase I/II for Safety and Efficacy of Nilotinib in a Population Steroid-refractory/or Steroid-dependent cGVHD | November 2011 | March 2016 |
| NCT01844765 | Completed | Phase 2 | Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients. | August 20, 2013 | August 28, 2020 |
| NCT01863745 | Completed | Phase 2 | Nilotinib Roll-over Protocol for Patients in Novartis-sponsored Nilotinib Study and Benefiting From Nilotinib Treatment | June 25, 2013 | October 2, 2023 |
| NCT01884922 | Completed | Phase 1 | Study Of Vinblastine in Combination With Nilotinib in Children, Adolescents and Young Adults | May 29, 2013 | April 28, 2016 |
| NCT01914484 | Completed | Phase 1/Phase 2 | Phase I/II Study of Nilotinib/Ruxolitinb Therapy for TKI Resistant Ph-Leukemia | August 1, 2013 | December 31, 2018 |
| NCT02081378 | Completed | Phase 1 | A Phase I Study of Oral Asciminib (ABL001) in Patients With CML or Ph+ ALL | April 24, 2014 | March 14, 2023 |
| NCT02253277 | Completed | Phase 1 | Safety and Tolerability of Combined Treatment With Nilotinib and Ruxolitinib in CML and Ph+ ALL Patients | February 18, 2015 | April 3, 2018 |
| NCT02272777 | Completed | Phase 3 | A Study of Imatinib and Nilotinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase | July 17, 2014 | January 30, 2017 |
| NCT02281474 | Completed | Phase 1 | Nilotinib in Cognitively Impaired Parkinson Disease Patients 001 | November 2014 | |
| NCT02353728 | Completed | Phase 2 | Stem Cell Monitoring for CML Patients Undergoing Nilotinib Therapy | January 2015 | February 2021 |
| NCT02546674 | Completed | Phase 4 | Study Assessing Deep Molecular Response in Adult Patients With CML in Chronic Phase Treated With Nilotinib Firstline. | February 18, 2016 | March 25, 2021 |
| NCT02733445 | Completed | Metabolic Outcomes in Patients Receiving Tyrosine Kinase Inhibitor (TKI) Therapy With Dasatinib or Nilotinib | December 2015 | March 2016 | |
| NCT03332511 | Completed | Phase 4 | Efficacy and Safety of Nilotinib in CML-CP | May 6, 2013 | October 24, 2016 |
| NCT03885830 | Completed | Precision Dosing of Tyrosine Kinase Inhibitors in CML Patients | June 20, 2019 | June 15, 2022 | |
| NCT03932669 | Completed | Phase 2 | Effect of Nilotinib in Cerebellar Ataxia Patients | November 19, 2018 | August 13, 2020 |
| NCT05286528 | Completed | Study to Evaluate Chronic Myeloid Leukemia Treatment Landscape and Real-life Treatment Outcomes in Hungary: Analysis of National Health Insurance Fund Database | November 18, 2020 | January 31, 2022 | |
| NCT05734053 | Completed | Nilotinib for Patients With Chronic Myeloid Leukemia in First Line and Any Subsequent Line | June 28, 2016 | September 8, 2022 | |
| NCT04518644 | No longer available | Nilotinib, for Patients With CML-CP or CML-AP | |||
| NCT04498871 | No longer available | MAP to Provide Access to Nilotinib, for Patients With HES | |||
| NCT04559555 | No longer available | MAP to Provide Access to Nilotinib, for Patients With Relapsed or Refractory Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia | |||
| NCT00413270 | No longer available | Oral Nilotinib in Adults With Chronic Myeloid Leukemia (CML) in Blast Crisis Who Are Imatinib Resistant or Intolerant | December 2006 | ||
| NCT06409936 | Not yet recruiting | Phase 2 | PEARL Study: PotEntial of Asciminib in the eaRly Treatment of CML | September 2024 | September 2031 |
| NCT04877522 | Recruiting | Phase 4 | Asciminib Roll-over Study | August 30, 2022 | August 30, 2027 |
| NCT04681820 | Recruiting | Evaluating Efficacy and Safety of Flumatinib for Chronic Phase Chronic Myeloid Leukemia(CML-CP) Without Optimal Response (Warning,Failure) to Imatinib or Dasatinib | November 1, 2020 | November 2024 | |
| NCT04835584 | Recruiting | Phase 1/Phase 2 | KRT-232 and TKI Study in Chronic Myeloid Leukemia | May 7, 2021 | June 30, 2026 |
| NCT02326311 | Recruiting | Phase 3 | Optimization of TKIs Treatment and Quality of Life in Ph+ CML Patients ≥60 Years in Deep Molecular Response | June 10, 2015 | December 31, 2023 |
| NCT04838041 | Recruiting | Phase 2 | 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 | November 11, 2021 | July 2029 |
| NCT02611492 | Recruiting | Phase 3 | A Phase III Randomized Trial of the Reduction of Chemotherapy in Philadelphia Chromosome-positive ALL of Young Adults | April 2016 | December 2025 |
| NCT01316250 | Recruiting | N/A | Gleevec as Maintenance Therapy After Cytogenetic Response With Nilotinib in Newly Diagnosed Chronic Myelogenous Leukemia | August 2010 | July 2025 |
| NCT02925234 | Recruiting | Phase 2 | The Drug Rediscovery Protocol (DRUP Trial) | August 2016 | December 2027 |
| NCT05185947 | Recruiting | Phase 2 | Study of Intravenous and Intraperitoneal Paclitaxel and Oral Nilotinib for Peritoneal Carcinomatosis From Colorectal, Appendiceal, Small Bowel, Gastric, Cholangiocarcinoma, Breast, Ovarian, or Other Gynecologic Primary Cancer | October 13, 2022 | December 30, 2031 |
| NCT03516279 | Recruiting | Phase 2 | Pembrolizumab and Dasatinib, Imatinib Mesylate, or Nilotinib in Treating Patients With Chronic Myeloid Leukemia and Persistently Detectable Minimal Residual Disease | June 26, 2019 | August 31, 2031 |
| NCT05456191 | Recruiting | Phase 3 | A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in Adult Participants (≥18 Years of Age) With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP) | November 21, 2022 | March 15, 2027 |
| NCT04205903 | Recruiting | Phase 1 | Nilotinib in Preventing Paclitaxel-Induced Peripheral Neuropathy in Patients With Stage I-III Breast Cancer | December 11, 2020 | January 2, 2024 |
| NCT02108951 | Terminated | Phase 3 | Study to Assess Efficacy and Safety of Nilotinib 300mg Twice Daily in Patients With Philadelphia Positive Chronic Myeloid Leukaemia (CML) in Chronic Phase Who Are Intolerant to Prior Tyrosine Kinase Inhibitors. | July 7, 2014 | August 10, 2016 |
| NCT01131325 | Terminated | Phase 4 | Study of Nilotinib in Ph+ CML-CP Patients With Low Imatinib Trough Plasma Concentrations | October 21, 2010 | May 12, 2011 |
| NCT01089595 | Terminated | Phase 2 | Trial of Tasigna (Nilotinib) 400 mg Twice Daily Alone or With Gleevec (Imatinib Mesylate) 400 mg Daily for Patients With Advanced Gastrointestinal Stromal Tumor (GIST) | February 2009 | March 2012 |
| NCT00905398 | Terminated | Phase 1/Phase 2 | Nilotinib With Chemotherapy for the Treatment of Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia | May 2009 | July 2015 |
| NCT00782834 | Terminated | Phase 2 | Nilotinib in Advanced Gastrointestinal Stromal Tumors (GIST) | July 2008 | October 2009 |
| NCT01751425 | Terminated | Phase 1 | Ruxolitinib in Treating Participants With Chronic Myeloid Leukemia With Minimal Residual Disease While on Therapy With Tyrosine Kinase Inhibitors | July 24, 2013 | September 24, 2019 |
| NCT01222143 | Terminated | Phase 1/Phase 2 | Safety and Efficacy Study of Nilotinib Combined With Mitoxantrone, Etoposide, and High-dose Cytarabine Induction Chemotherapy Followed by Consolidation for Patients With C-kit Positive Acute Myeloid Leukemia | October 2010 | April 2015 |
| NCT02174445 | Terminated | Phase 3 | An Open-label, Randomised Multicenter Phase 3b Study to Determine the Confirmed Rate of Molecular Response ≥ 4 Log (MR4) at Two Years | March 2014 | October 2019 |
| NCT02115386 | Terminated | Phase 3 | Trial to Evaluate the Improvement of Chronic Low-grade AEs in Patients With Ph+ CML With Optimal Response to Imatinib When Switched to Nilotinib | December 17, 2015 | October 31, 2016 |
| NCT00751036 | Terminated | Phase 3 | Nilotinib 800 Mg And Imatinib 800 Mg For The Treatment Of Patients With Gastrointestinal Stromal Tumors (Gist) Refractory To Imatinib 400 Mg | June 2009 | August 2012 |
| NCT02709083 | Terminated | Phase 2 | Dasatinib or Nilotinib Followed by Imatinib in Patients With Newly Diagnosed, Chronic Phase Chronic Myeloid Leukemia | October 2016 | July 2018 |
| NCT01866553 | Terminated | Phase 2 | Nilotinib Plus Pegylated Interferon-α2b in CML | April 2013 | May 1, 2016 |
| NCT01201538 | Terminated | Phase 2 | A Study of Nilotinib in Growing Vestibular Schwannomas | October 2010 | October 2013 |
| NCT00644878 | Terminated | Phase 2 | 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 | October 2008 | March 2012 |
| NCT02225574 | Terminated | Phase 1 | An Open-Label, Phase I/II Study of Nilotinib (Tasigna) and MEK-162 (ARRY-162) Used in Combination for Patients With Refractory or Advanced Chronic Myeloid Leukemia and Philadelphia Positive Acute Leukemia (Protocol CAMN107AUS41T) | March 11, 2015 | February 2, 2017 |
| NCT01179737 | Terminated | Phase 2 | Efficacy, Safety, Tolerability and Pharmacokinetics (PK) of Nilotinib (AMN107) in Pulmonary Arterial Hypertension (PAH) | July 2010 | January 2013 |
| NCT01804985 | Unknown status | Phase 2 | De- Escalation and Stopping Treatment of Imatinib, Nilotinib or sprYcel in Chronic Myeloid Leukaemia | December 2013 | May 2018 |
| NCT02389920 | Unknown status | Phase 4 | Multicenter, PhaseⅣ, Open Label Trial of Nilotinib in Adult Patients Diagnosed Philadelphia Chromosome Positive(Ph+) Chronic Myeloid Leukemia in CP/AP Intolerant to Dasatinib | April 2015 | December 2018 |
| NCT03942094 | Unknown status | Phase 3 | Nilotinib for First-line Newly Diagnosed CML-CP Patients | June 1, 2019 | December 1, 2023 |
| NCT01562847 | Unknown status | Prospective Investigation of Dynamics of ABL Mutations in Imatinib Failed CML Patients Treated With Nilotinib | July 2011 | June 2015 | |
| NCT02602314 | Unknown status | Phase 4 | Sustained Treatment-free Remission in BCR-ABL+ Chronic Myeloid Leukemia | November 11, 2016 | February 2024 |
| NCT01168050 | Unknown status | Phase 2 | Efficacy of Nilotinib in First or Second Line Treatment of Primary Melanomas Stage III Unresectable Melanomas. | July 2010 | December 2013 |
| NCT01270893 | Withdrawn | Phase 2 | Tasigna Neoadjuvant Gastrointestinal Stromal Tumor (GIST) | January 2011 | |
| NCT02973711 | Withdrawn | Phase 1/Phase 2 | A Study of Ruxolitinib in Combination With Nilotinib in Patients With Chronic Phase CML | January 2018 | August 2021 |
| NCT02774512 | Withdrawn | Early Phase 1 | Predictive Biomarkers of Biological Activity and Efficacy of Nilotinib on ZAK Target in Non-metastatic Colon Cancer | May 2016 | November 2017 |
| NCT01670084 | Withdrawn | Phase 2 | Nilotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia or Blastic Phase Chronic Myelogenous Leukemia | December 2012 | September 2017 |
- Trade name (Drug list of Screening Committee of Anticancer Drugs)
- Tasigna
- US Approved Year (20160209) (Drug list of Screening Committee of Anticancer Drugs)
- 2007
- Japan Approved Year (20160209) (Drug list of Screening Committee of Anticancer Drugs)
- 2009
- Target (Drug list of Screening Committee of Anticancer Drugs)
- Bcr-Abl
- Disease name (Drug list of Screening Committee of Anticancer Drugs)
- CML