Therapy Detail
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| Therapy Name | Nilotinib |
| Synonyms | |
| Therapy Description |
Tasigna (nilotinib) inhibits several tyrosine kinases including BCR-ABL, PDGFR, KIT, DDR and CSF-1R, potentially resulting in reduced tumor cell proliferation (PMID: 21419934, PMID: 25284748). Tasigna (nilotinib) is FDA approved for use in patients with Ph+ (BCR-ABL1) chronic myeloid leukemia (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Nilotinib | Tasigna | AMN-107|AMN107 | ABL Inhibitor (pan) 9 BCR-ABL Inhibitor 30 CSF1R Inhibitor 28 DDR1 Inhibitor 10 DDR2 inhibitor 7 KIT Inhibitor 57 PDGFR Inhibitor (Pan) 30 | Tasigna (nilotinib) inhibits several tyrosine kinases including BCR-ABL, PDGFR, KIT, DDR and CSF-1R, potentially resulting in reduced tumor cell proliferation (PMID: 21419934, PMID: 25284748). Tasigna (nilotinib) is FDA approved for use in patients with Ph+ (BCR-ABL1) chronic myeloid leukemia (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| KIT S476I | mast-cell leukemia | predicted - sensitive | Nilotinib | Preclinical - Patient cell culture | Actionable | In a preclinical study, treatment with Tasigna (nilotinib) decreased proliferation of patient-derived neoplastic mast cells harboring KIT S476I in culture (PMID: 25209843). | 25209843 |
| KIT D816V | Advanced Solid Tumor | decreased response | Nilotinib | Preclinical | Actionable | In a preclinical study, Tasigna (nilotinib) decreased viability of cells expressing KIT D816V in culture, but did not inhibit KIT phosphorylation or growth of KIT D816V-expressing tumors in mouse models (PMID: 20442311). | 20442311 |
| KIT L576P | melanoma | predicted - sensitive | Nilotinib | Case Reports/Case Series | Actionable | In a Phase II trial, Tasigna (nilotinib) resulted in an overall response rate of 26.2% (11/41) including three melanoma patients harboring KIT L576P demonstrating a partial response (PMID: 28327988). | 28327988 |
| KIT W557R KIT L576P | melanoma | predicted - sensitive | Nilotinib | Case Reports/Case Series | Actionable | In a Phase II trial, Tasigna (nilotinib) resulted in an overall response rate of 26.2% (11/41) including a melanoma patient co-harboring KIT L576P and KIT W557R demonstrating a partial response and a progression free survival of 5.3 months and overall survival of 14.7 months when treated with Tasigna (nilotinib) (PMID: 28327988). | 28327988 |
| KIT exon11 | melanoma | sensitive | Nilotinib | Phase II | Actionable | In a Phase II trial, Tasigna (nilotinib) treatment resulted in complete response in 5% (1/19) and partial response in 21% (4/19) of melanoma patients harboring KIT exon 11 or exon 13 mutations (PMID: 28843487; NCT01168050). | 28843487 |
| KIT exon11 | melanoma | sensitive | Nilotinib | Phase II | Actionable | In a Phase II trial, Tasigna (nilotinib) resulted in an overall response rate of 26.2% (11/41), which included a partial response of 38.5% (10/26) and a progression free survival of 5.4 months in melanoma patients harboring KIT exon 11 mutations (PMID: 28327988). | 28327988 |
| KIT V559D | melanoma | predicted - sensitive | Nilotinib | Case Reports/Case Series | Actionable | In a Phase II trial, Tasigna (nilotinib) resulted in an overall response rate of 26.2% (11/41) including a melanoma patient harboring KIT V559D demonstrating a partial response and progression free survival of 28.3 months and overall survival of 28.3 months (PMID: 28327988). | 28327988 |
| KIT exon13 | melanoma | sensitive | Nilotinib | Phase II | Actionable | In a Phase II trial, Tasigna (nilotinib) treatment resulted in complete response in 5% (1/19) and partial response in 21% (4/19) of melanoma patients harboring KIT exon 11 or exon 13 mutations (PMID: 28843487; NCT01168050). | 28843487 |
| KIT exon13 | melanoma | sensitive | Nilotinib | Phase II | Actionable | In a Phase II trial, Tasigna (nilotinib) resulted in an overall response rate of 26.2% (11/41), which included a partial response in 7.7% (1/13) of melanoma patients harboring KIT exon 13 mutations (PMID: 28327988). | 28327988 |
| KIT T670I | melanoma | resistant | Nilotinib | Preclinical | Actionable | In a preclinical study, melanoma cells expressing KIT T670I demonstrated resistance to treatment with Tasigna (nilotinib) (PMID: 23582185, PMID: 25594040). | 23582185 25594040 |
| KIT W557_K558del | Advanced Solid Tumor | sensitive | Nilotinib | Preclinical - Cell culture | Actionable | In a preclinical study, Tasigna (nilotinib) inhibited growth of transformed cells expressing KIT W557_K558del in culture (PMID: 17699867). | 17699867 |
| KIT mutant | melanoma | sensitive | Nilotinib | Phase II | Actionable | In a Phase II trial, Tasigna (nilotinib) treatment resulted in complete response in 4% (1/25), durable partial response in 16% (4/25), and stable disease in 56% (14/25) of melanoma patients harboring KIT mutations (PMID: 28843487; NCT01168050). | 28843487 |
| KIT mutant | melanoma | sensitive | Nilotinib | Phase II | Actionable | In a Phase II trial, Tasigna (nilotinib) treatment in patients with melanoma harboring KIT mutations resulted in an overall response rate of 26.2% (11/42), which included 11 patients with a partial response, a median duration of response of 7.1 months, and an overall survival of 18 months (PMID: 28327988; NCT01028222). | 28327988 |
| KIT W557R | melanoma | predicted - sensitive | Nilotinib | Case Reports/Case Series | Actionable | In a Phase II trial, Tasigna (nilotinib) resulted in an overall response rate of 26.2% (11/41) including a melanoma patient harboring KIT W557R demonstrating a partial response and progression free survival of 35.4 months and overall survival of 35.4 months (PMID: 28327988). | 28327988 |
| ABL1 rearrange | myeloid neoplasm | sensitive | Nilotinib | Guideline | Actionable | Tasigna (nilotinib) is included in guidelines as a preferred regimen for patients with a myeloid/lymphoid neoplasm with eosinophilia harboring a ABL1 rearrangement (NCCN.org). | detail... |
| KIT act mut | skin melanoma | sensitive | Nilotinib | Guideline | Actionable | Tasigna (nilotinib) is included in guidelines as second-line therapy for metastatic or unresectable cutaneous melanoma patients with KIT activating mutations (NCCN.org). | detail... |
| KIT exon11 | gastrointestinal stromal tumor | sensitive | Nilotinib | Phase III | Actionable | In a Phase III trial, a 24 month progression free survival was observed in 69.6% of advanced GIST patients harboring KIT exon 11 mutations when treated with Tasigna (nilotinib) (J Clin Oncol May 2013 vol. 31 no. 15_suppl 10501). | detail... |
| KIT K642E | melanoma | predicted - sensitive | Nilotinib | Case Reports/Case Series | Actionable | In a Phase II trial, Tasigna (nilotinib) resulted in an overall response rate of 26.2% (11/41) including a melanoma patient harboring KIT K642E demonstrating a partial response and a progression free survival of 5.8 months and overall survival of 18.6 months (PMID: 28327988). | 28327988 |
| KIT W557_K558del KIT T670I | Advanced Solid Tumor | resistant | Nilotinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing a KIT W557_K558del/T670I double mutation demonstrated resistance to Tasigna (nilotinib) in culture (PMID: 17699867). | 17699867 |
| KIT A829P | melanoma | sensitive | Nilotinib | Preclinical | Actionable | In a preclinical study, Tasigna (nilotinib) demonstrated efficacy by inhibiting proliferation of cultured melanoma cells expressing KIT A829P (PMID: 23582185, PMID: 25594040). | 23582185 25594040 |
| KIT V560G | Advanced Solid Tumor | sensitive | Nilotinib | Preclinical | Actionable | In a preclinical study, transformed cells expressing KIT V560G demonstrated inhibition of cell proliferation and tumor regression both in culture and in vivo when treated with Tasigna (nilotinib) (PMID: 20442311). | 20442311 |
| KIT V560del KIT V654A | Advanced Solid Tumor | sensitive | Nilotinib | Preclinical - Cell culture | Actionable | In a preclinical study, Tasigna (nilotinib) inhibited proliferation of transformed cells expressing a KIT V560del/V654A double mutation in culture (PMID: 17699867). | 17699867 |
| KIT V559A | melanoma | predicted - sensitive | Nilotinib | Case Reports/Case Series | Actionable | In a Phase II trial, Tasigna (nilotinib) resulted in an overall response rate of 26.2% (11/41), including a melanoma patient harboring KIT V559A demonstrating a partial response and progression-free survival of 19.4 months and overall survival of 32.9 months (PMID: 28327988). | 28327988 |
| KIT V560D | melanoma | predicted - sensitive | Nilotinib | Case Reports/Case Series | Actionable | In a Phase II trial, Tasigna (nilotinib) resulted in an overall response rate of 26.2% (11/41) including a melanoma patient harboring KIT V560D demonstrating a partial response and progression free survival of 8.6 months and overall survival of 23.5 months (PMID: 28327988). | 28327988 |
| ABL1 G250R ABL1 G251D | oral cavity cancer | no benefit | Nilotinib | Case Reports/Case Series | Actionable | In a clinical case study, Tasigna (nilotinib) treatment resulted in no benefit in a patient with oral cavity cancer harboring ABL1 G250R and G251D (PMID: 28514312). | 28514312 |
| KIT V559D KIT D820Y | Advanced Solid Tumor | sensitive | Nilotinib | Preclinical - Cell culture | Actionable | In a preclinical study, Tasigna (nilotinib) inhibited proliferation of transformed cells expressing a KIT V559D/D820Y double mutation in culture, with increased potency compared to Sprycel (dasatinib) or Nexavar (sorafenib) (PMID: 17699867). | 17699867 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT02779283 | Phase I | Dasatinib Nilotinib Ponatinib Sorafenib Cytarabine + Idarubicin Sunitinib | Personalized Kinase Inhibitor Therapy Combined With Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia | Completed | USA | 0 |
| NCT01140568 | Phase II | Nilotinib | Study of Platelet Derived Growth Factor Receptor (PDGFR) in Recurrent Malignant Gliomas | Completed | USA | 0 |
| NCT01028222 | Phase II | Nilotinib | A Study of AMNN107 in the Treatment of Metastatic and/or Inoperable Melanoma Harboring a c-Kit Mutation | Completed | USA | ITA | ESP | DEU | CAN | BEL | AUS | 7 |
| NCT04877522 | FDA approved | Asciminib Bosutinib Dasatinib Nilotinib Asciminib + Imatinib | Asciminib Roll-over Study | Recruiting | USA | ITA | GBR | FRA | ESP | DEU | CAN | AUT | 17 |
| NCT03874858 | Phase II | Nilotinib Asciminib + Nilotinib | De-escalation and TFR Study in CML Patients Treated With Nilotinib Followed by a Second Attempt After Nilotinib and Asciminib Combination (DANTE) | Recruiting | ITA | 0 |
| NCT02788201 | Phase II | Erlotinib Thiotepa Imatinib Dacarbazine Arsenic trioxide Idarubicin Mitomycin C Thioguanine Mercaptopurine Methotrexate Cladribine Epirubicin Gemcitabine Doxorubicin Bleomycin Etoposide Gefitinib Daunorubicin Lomustine Sorafenib Sunitinib Ifosfamide Asparaginase Ixabepilone Abiraterone Azacitidine Ruxolitinib Decitabine Axitinib Estramustine Floxuridine Lapatinib Carmustine Fludarabine Nilotinib Cisplatin Vismodegib Vandetanib Melphalan Busulfan Carboplatin Toremifene Crizotinib Dactinomycin Temsirolimus Vorinostat Romidepsin Fluorouracil Irinotecan Bortezomib Tamoxifen Topotecan Chlorambucil Pentostatin Eribulin Carfilzomib Vemurafenib Hydroxyurea Exemestane Vincristine Sulfate Dasatinib Mitoxantrone Vinblastine Cytarabine Tretinoin Clofarabine Teniposide Docetaxel Pazopanib Oxaliplatin Streptozocin Paclitaxel Bendamustine Mechlorethamine Mitotane | Genomic Based Assignment of Therapy in Advanced Urothelial Carcinoma | Completed | USA | 0 |
| NCT02602314 | FDA approved | Imatinib Nilotinib | Sustained Treatment-free Remission in BCR-ABL+ Chronic Myeloid Leukemia (SUSTRENIM) | Active, not recruiting | ITA | 1 |
| NCT01207492 | Phase II | Nilotinib | Nilotinib in Patients With Relapsed or Metastatic Pigmented Villonodular Synovitis/Tenosynovial Giant Cell Tumor/Diffuse-Type Giant Cell Tumor | Active, not recruiting | USA | 0 |
| NCT02917720 | Phase II | Nilotinib | 2nd or 3rd TKI-stop After 2 Years Nilotinib Pre-treatment in CML-patients (NAUT) | Active, not recruiting | DEU | 1 |
| NCT04971226 | Phase III | Asciminib Bosutinib Imatinib Dasatinib Nilotinib | A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP | Active, not recruiting | USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS | 19 |
| NCT03578367 | Phase II | Imatinib Nilotinib Asciminib + Imatinib | Study of Efficacy and Safety of Asciminib in Combination With Imatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CML-CP) | Recruiting | USA | ITA | GBR | FRA | ESP | DEU | CAN | AUT | AUS | 10 |
| NCT02029001 | Phase II | Durvalumab + Tremelimumab Olaparib Pazopanib Nilotinib | Adapting Treatment to the Tumor Molecular Alterations for Patients With Advanced Solid Tumors: MyOwnSpecificTreatment (MOST plus) | Recruiting | FRA | 0 |
| NCT00129740 | Phase II | Nilotinib | Phase II Nilotinib With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML) | Completed | USA | 0 |
| NCT01244750 | Phase I | Imatinib Dasatinib Nilotinib | Studying First Line Treatment of Chronic Myeloid Leukemia (CML) in a Real-world Setting | Completed | USA | ITA | FRA | ESP | DEU | 3 |
| NCT01222143 | Phase Ib/II | Cytarabine + Etoposide + Mitoxantrone Nilotinib | 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 | Terminated | CAN | 0 |
| NCT01806571 | Phase II | Cytarabine + Daunorubicin Nilotinib | Daunorubicin Hydrochloride, Cytarabine, and Nilotinib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia | Completed | USA | 0 |
| NCT03784014 | Phase III | Ceritinib Dabrafenib + Trametinib Capmatinib Durvalumab + Olaparib Nilotinib Futibatinib Trametinib Palbociclib Glasdegib Lapatinib | Molecular Profiling of Advanced Soft-tissue Sarcomas (MULTISARC) | Recruiting | FRA | 0 |
| NCT02709083 | Phase II | Dasatinib Nilotinib Imatinib | Dasatinib or Nilotinib Followed by Imatinib in Patients With Newly Diagnosed, Chronic Phase Chronic Myeloid Leukemia | Terminated | USA | 0 |
| NCT01784068 | Phase II | Nilotinib | Nilotinib Treatment-free Remission Study in CML (Chronic Myeloid Leukemia) Patients (ENESTfreedom) | Active, not recruiting | USA | ITA | GBR | FRA | ESP | DEU | BEL | AUT | 11 |
| NCT02551718 | Phase I | Bosutinib Irinotecan Romidepsin Busulfan Melphalan Nilotinib Crizotinib Cytarabine Mitoxantrone Dasatinib Pazopanib Paclitaxel Clofarabine Hydroxyurea Tretinoin Carfilzomib Nelarabine Bexarotene Pentostatin Everolimus Cabozantinib Mercaptopurine Methotrexate Cladribine Thioguanine Daunorubicin Ponatinib Etoposide Afatinib Gefitinib Gemcitabine Regorafenib Arsenic trioxide Trametinib Imatinib Erlotinib Dabrafenib Decitabine Axitinib Azacitidine Ruxolitinib Fludarabine Lapatinib Ceritinib Sirolimus Sorafenib Lomustine Sunitinib Cabazitaxel Temsirolimus Topotecan Bortezomib Pralatrexate | High Throughput Drug Sensitivity Assay and Genomics- Guided Treatment of Patients With Relapsed or Refractory Acute Leukemia | Completed | USA | 0 |
| NCT03654768 | Phase II | Bosutinib Dasatinib Nilotinib Dasatinib + Ruxolitinib Bosutinib + Ruxolitinib Nilotinib + Ruxolitinib | Testing the Addition of Ruxolitinib to the Usual Treatment (Tyrosine Kinase Inhibitors) for Chronic Myeloid Leukemia | Active, not recruiting | USA | 0 |
| NCT04518644 | Expanded access | Nilotinib | Nilotinib, for Patients With CML-CP or CML-AP | No longer available | 0 | |
| NCT01698905 | Phase II | Nilotinib | Treatment-free Remission After Achieving Sustained MR4.5 on Nilotinib (ENESTop) (ENESTop) | Active, not recruiting | USA | GBR | FRA | ESP | DEU | CAN | BEL | AUS | 10 |
| NCT01407198 | Phase I | Nilotinib | Nilotinib With Radiation for High Risk Chordoma | Active, not recruiting | USA | 0 |
| NCT01620216 | Phase II | Sunitinib Dasatinib Nilotinib Ponatinib Sorafenib | Validation of an in Vitro Assay to Predict Targeted Therapies for Acute Leukemia Patients | Terminated | USA | 0 |
| NCT02326311 | Phase III | Dasatinib Nilotinib Imatinib | Optimization of TKIs Treatment and Quality of Life in Ph+ CML Patients >=60 Years in Deep Molecular Response | Recruiting | ITA | 0 |
| NCT02353728 | Phase II | Nilotinib | Stem Cell Monitoring for CML Patients Undergoing Nilotinib Therapy | Completed | USA | 0 |
| NCT01844765 | Phase II | Nilotinib | Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients. | Completed | USA | ITA | GBR | FRA | ESP | 8 |
| NCT01201538 | Phase II | Nilotinib | A Study of Nilotinib in Growing Vestibular Schwannomas | Terminated | CAN | 0 |
| NCT01744665 | Phase II | Nilotinib | Safety and Efficacy of CML Patients Who Switch to Nilotinib and Stop Treatment After Achieving and Sustaining MR4.5. (ENESTgoal) | Completed | USA | 0 |
| NCT00471497 | Phase III | Nilotinib Imatinib | A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) (ENESTnd) | Completed | USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | 26 |
| NCT01077544 | Phase I | Nilotinib | A Pharmacokinetic (PK) Study of Nilotinib in Pediatric Patients With Philadelphia Chromosome-positive (Ph+) Chronic Myelogenous Leukemia (CML) or Acute Lymphoblastic Leukemia (ALL) | Completed | ITA | GBR | FRA | 1 |
| NCT05456191 | Phase III | Asciminib Nilotinib | 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) (ASC4START) | Recruiting | USA | ITA | GBR | FRA | DEU | CAN | 17 |
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