Therapy Detail
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| Therapy Name | Axitinib |
| Synonyms | |
| Therapy Description |
Inlyta (axitinib) inhibits the VEGFRs, PDGFR, and KIT, potentially resulting in decreased angiogenesis and reduced tumor growth (PMID: 16027439, PMID: 25709499). Inlyta (axitinib) is approved for renal cell carcinoma (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Axitinib | Inlyta | AG-013736|AG013736 | KIT Inhibitor 55 PDGFR Inhibitor (Pan) 28 VEGFR Inhibitor (Pan) 33 | Inlyta (axitinib) inhibits the VEGFRs, PDGFR, and KIT, potentially resulting in decreased angiogenesis and reduced tumor growth (PMID: 16027439, PMID: 25709499). Inlyta (axitinib) is approved for renal cell carcinoma (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| KIT V559G | Advanced Solid Tumor | sensitive | Axitinib | Preclinical - Cell culture | Actionable | In a preclinical study, Inlyta (axitinib) inhibited KIT phosphorylation and proliferation of transformed cells expressing KIT V559G in culture (PMID: 31205508). | 31205508 |
| KIT K642E | gastrointestinal stromal tumor | sensitive | Axitinib | Preclinical - Patient cell culture | Actionable | In a preclinical study, Inlyta (axitinib) inhibited phosphorylation of KIT and downstream signaling, reduced proliferation, and induced cell-cycle arrest in a cultured gastrointestinal stromal tumor (GIST) cell line harboring KIT K642E, and inhibited proliferation of primary GIST cells harboring KIT K642E in culture (PMID: 31205508). | 31205508 |
| KIT T670I | Advanced Solid Tumor | sensitive | Axitinib | Preclinical - Cell culture | Actionable | In a preclinical study, Inlyta (axitinib) inhibited KIT phosphorylation and proliferation of transformed cells expressing KIT T670I in culture, however, with decreased potency compared to its potency against other KIT variants (PMID: 31205508). | 31205508 |
| KIT V654A | Advanced Solid Tumor | sensitive | Axitinib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Inlyta (axitinib) inhibited KIT phosphorylation and proliferation of transformed cells expressing KIT V654A in culture, and inhibited tumor growth in xenograft models (PMID: 31205508). | 31205508 |
| KIT V559D KIT V654A | Advanced Solid Tumor | sensitive | Axitinib | Preclinical - Cell culture | Actionable | In a preclinical study, Inlyta (axitinib) inhibited KIT phosphorylation and proliferation of transformed cells expressing KIT V654A and KIT V559D in culture (PMID: 31205508). | 31205508 |
| KIT V559D | Advanced Solid Tumor | sensitive | Axitinib | Preclinical - Cell culture | Actionable | In a preclinical study, Inlyta (axitinib) inhibited KIT phosphorylation and proliferation of transformed cells expressing KIT V559D in culture (PMID: 31205508). | 31205508 |
| KIT V559A | Advanced Solid Tumor | sensitive | Axitinib | Preclinical - Cell culture | Actionable | In a preclinical study, Inlyta (axitinib) inhibited KIT phosphorylation and proliferation of transformed cells expressing KIT V559A in culture (PMID: 31205508). | 31205508 |
| KIT V560_Y578del KIT T670I | gastrointestinal stromal tumor | sensitive | Axitinib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Inlyta (axitinib) inhibited KIT phosphorylation and downstream signaling, reduced proliferation, and induced cell-cycle arrest in a gastrointestinal stromal tumor cell line harboring KIT V560_Y578del and KIT T670I in culture, and inhibited tumor growth in xenograft models (PMID: 31205508). | 31205508 |
| KIT A829P | Advanced Solid Tumor | sensitive | Axitinib | Preclinical - Cell culture | Actionable | In a preclinical study, Inlyta (axitinib) inhibited KIT phosphorylation and proliferation of transformed cells expressing KIT A829P in culture, however, with decreased potency compared to its potency against other KIT variants (PMID: 31205508). | 31205508 |
| KIT V560_Y578del | gastrointestinal stromal tumor | sensitive | Axitinib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Inlyta (axitinib) inhibited KIT phosphorylation and downstream signaling, reduced proliferation and induced cell-cycle arrest in a gastrointestinal stromal tumor cell line harboring KIT V560_Y578del in culture, and inhibited tumor growth in xenograft models (PMID: 31205508). | 31205508 |
| KIT L576P | Advanced Solid Tumor | sensitive | Axitinib | Preclinical - Cell culture | Actionable | In a preclinical study, Inlyta (axitinib) inhibited KIT phosphorylation and proliferation of transformed cells expressing KIT L576P in culture (PMID: 31205508). | 31205508 |
| KIT V559D | gastrointestinal stromal tumor | sensitive | Axitinib | Preclinical - Patient cell culture | Actionable | In a preclinical study, Inlyta (axitinib) inhibited proliferation of gastrointestinal stromal tumor patient-derived primary cells harboring KIT V559D in culture (PMID: 31205508). | 31205508 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT02639182 | Phase II | AGS16F Axitinib | A Study of AGS-16C3F vs. Axitinib in Metastatic Renal Cell Carcinoma | Completed | USA | CAN | 0 |
| NCT03438708 | Phase II | Axitinib | Prior Axitinib as a Determinant of Outcome of Renal Surgery (PADRES) | Unknown status | USA | 0 |
| NCT02579811 | Phase II | Axitinib | Axitinib Given on an Individualized Schedule for Metastatic Renal Cell Cancer | Active, not recruiting | USA | 0 |
| NCT05096390 | Phase II | Axitinib + Pembrolizumab Axitinib | Axitinib +/- Pembrolizumab in First Line Treatment of mPRCC (PAXIPEM) | Recruiting | FRA | 0 |
| 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 |
| NCT01409200 | Phase II | Axitinib | Neoadjuvant Axitinib in Prostate Cancer | Active, not recruiting | USA | 0 |
| NCT01599754 | Phase III | Axitinib | Adjuvant Axitinib Therapy of Renal Cell Cancer in High Risk Patients | Terminated | USA | FRA | ESP | 6 |
| NCT03092856 | Phase II | Axitinib Axitinib + PF-04518600 | Axitinib With or Without Anti-OX40 Antibody PF-04518600 in Treating Patients With Metastatic Kidney Cancer | Active, not recruiting | USA | 0 |
| NCT01540526 | Phase I | Axitinib | Pharmacodynamic Study With FLT-PET/CT in Patients With Prostate/Other Solid Malignancies Treated With High Dose Axitinib | Completed | USA | 0 |
| NCT00828919 | Phase I | Axitinib | Continuing Access To AG- 013736 (A406) For Patients Previously Receiving AG 013736 In Clinical Trials | Unknown status | USA | ITA | FRA | DEU | 7 |
| NCT02560012 | Phase II | Everolimus Sorafenib Temsirolimus Axitinib Sunitinib Pazopanib | Personalized Targeted Inhibitors Treatment in Renal Cell Cancer | Terminated | USA | 0 |
| NCT01727336 | Phase II | Axitinib + Dalantercept Axitinib | Study of Dalantercept in Patients With Advanced Renal Cell Carcinoma | Terminated | USA | 0 |
| NCT03297606 | Phase II | Bosutinib Palbociclib Vismodegib Ipilimumab + Nivolumab Cobimetinib + Vemurafenib Temsirolimus Olaparib Erlotinib Crizotinib Sunitinib Afatinib Dasatinib Pertuzumab + Trastuzumab Axitinib | Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) | Recruiting | CAN | 0 |
| NCT01649180 | Phase II | Axitinib | NEXT: Subsequent Exposure to Tyrosine Kinase Inhibition at Recurrence After Adjuvant Therapy in Renal Cell Carcinoma (PrE0801) | Terminated | USA | 0 |
| NCT01533948 | Phase II | Axitinib | Axitinib in Treating Patients With Melanoma That is Metastatic or Cannot Be Removed By Surgery | Terminated | USA | 0 |
| NCT02762513 | Phase II | Axitinib | Expansion Trial for Axitinib In Head And Neck Cancer | Completed | USA | 0 |
| NCT02667886 | Phase Ib/II | Axitinib X4P-001 | Trial of X4P-001 in Patients With Advanced Renal Cell Carcinoma | Completed | USA | 1 |
| NCT01508117 | Phase II | Axitinib | Phase II Axitinib (AG-013736) in Elderly Glioblastoma Multiforme (GBM) Patients | Terminated | USA | 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 |
| NCT03595124 | Phase II | Nivolumab Axitinib + Nivolumab Axitinib | A Study to Compare Treatments for a Type of Kidney Cancer Called TFE/Translocation Renal Cell Carcinoma (tRCC) | Recruiting | USA | 1 |
| NCT03839498 | Phase II | Axitinib | Study of Axitinib (AG-013736) With Evaluation of the VEGF-pathway in Pheochromocytoma/Paraganglioma | Recruiting | USA | 0 |
| NCT01321437 | Phase II | Axitinib | Study of the Anti-Angiogenesis Agent Axitinib in Patients With Stage III Malignant Melanoma | Completed | USA | 0 |
| NCT02164838 | Phase I | Axitinib | VEGF Receptor Tyrosine Kinase Inhibitor Axitinib in Children With Recurrent or Refractory Solid Tumors | Completed | USA | CAN | 0 |
| NCT01967576 | Phase II | Axitinib | Phase II Study of Axitinib (AG-013736) With Evaluation of the VEGF-pathway in Metastatic, Recurrent or Primary Unresectable Pheochromocytoma/Paraganglioma | Completed | USA | 0 |
| NCT02129647 | Phase II | Axitinib | Study of Axitinib in Patients With Neurofibromatosis Type 2 and Progressive Vestibular Schwannomas | Completed | USA | 0 |
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