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 | KIT Inhibitor 50 PDGFR Inhibitor (Pan) 27 VEGFR Inhibitor (Pan) 32 | 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 |
|---|---|---|---|---|---|---|---|
| Unknown unknown | thyroid gland cancer | not applicable | Axitinib | Phase II | Actionable | In a Phase II study, Inlyta (axitinib) demonstrated antitumor activity in patients with advanced refractory thyroid cancer, resulting in a 30% response rate with another 38% of patients having stable disease (PMID: 20694064). | 20694064 |
| Unknown unknown | neuroendocrine tumor | not applicable | Axitinib | Phase II | Actionable | In a Phase II clinical trial, treatment with Inlyta (axitinib) resulted in a median overall progression-free survival (PFS) of 26.7 months, a 12-month PFS rate of 74.5%, and median overall survival of 45.3 months, and led to partial response in 3% (1/30) and stable disease in 70% (21/30) of patients with neuroendocrine tumors, with some tumor shrinkage in 68% (15/22) of patients (PMID: 27080472). | 27080472 |
| Unknown unknown | renal cell carcinoma | not applicable | Axitinib | FDA approved | Actionable | In a Phase III trial that supported FDA approval, treatment with Inlyta (axitinib) as second-line therapy resulted in an improved progression-free survival of 8.3 months compared to 5.7 months with Nexavar (sorafenib) (HR 0.656, 95% CI 0.552-0.779; p<0.0001) in patients with metastatic renal cell carcinoma (PMID: 23598172). | 23598172 detail... |
| Unknown unknown | renal cell carcinoma | not applicable | Axitinib | Phase II | Actionable | In a Phase II clinical trial, treatment with Inlyta (axtinib) as first-line therapy resulted a prolonged median overall survival of 42.7 months compared to 30.4 months with placebo in patients with metastatic renal cell carcinoma (PMID: 27236772). | 27236772 |
| Unknown unknown | renal cell carcinoma | not applicable | Axitinib | Clinical Study | Actionable | In a meta-analysis, Inlyta (axitinib) improved progression-free survival in patients with metastatic renal cell carcinoma (PMID: 24037486). | 24037486 |
| Unknown unknown | nasopharynx carcinoma | not applicable | Axitinib | Clinical Study | Actionable | In a clinical trial, treatment with Inlyta (axitinib) resulted in a 3-month clinical benefit rate (CBR) of 78.4% (29/37; 1 confirmed partial response (PR), 6 unconfirmed PR, 22 stable disease for greater than 3 months) and 6-month CBR of 43.2%, a median progression-free survival of 5.0 months, and median overall survival of 10.4 months in patients with nasopharyngeal carcinoma (PMID: 29301831). | 29301831 |
| Unknown unknown | nasopharynx carcinoma | not applicable | Axitinib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Inlyta (axitinib) inhibited growth of nasopharyngeal carcinoma cell lines in culture, and inhibited tumor growth, decreased microvessel density, and increased tumor necrosis in a nasopharyngeal carcinoma xenograft model (PMID: 29301831). | 29301831 |
| 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 |
| Unknown unknown | Advanced Solid Tumor | not applicable | Axitinib | Phase I | Actionable | In a Phase I trial, Inlyta (axitinib), in combination with chemotherapeutics, demonstrated antitumor activity in 42% (17/42) of patients with advanced solid tumors (PMID: 22996612). | 22996612 |
| 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 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 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 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 |
| Unknown unknown | brain glioblastoma multiforme | not applicable | Axitinib | Preclinical | Actionable | In a preclinical study, Inlyta (axitinib) demonstrated efficacy in glioblastoma cells, including those resistant to Bevacizumab (J Clin Oncol (Meeting Abstracts) May 2013 vol. 31 no. 15_suppl 2077). | detail... |
| Unknown unknown | lung non-small cell carcinoma | not applicable | Axitinib | Phase II | Actionable | In a Phase II clinical trial, Inlyta (axitinib) was well-tolerated and demonstrated activity in patients with advanced non-small cell lung cancer, with a disease control rate of 41% (13/32), median progression-free survival of 4.9 months, and median overall survival of 14.8 months (PMID: 19597027). | 19597027 |
| 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 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 |
| 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 |
| Unknown unknown | breast cancer | not applicable | Axitinib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Inlyta (axitinib) disrupted tumor microvasculature and inhibited tumor growth in breast cancer cell line xenograft models (PMID: 17371720). | 17371720 |
| 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 |
| Unknown unknown | melanoma | not applicable | Axitinib | Phase II | Actionable | In a Phase II study in patients with metastatic melanoma, Inlyta (axitinib) was well tolerated and demonstrated antitumor activity (PMID: 21976544). | 21976544 |
| 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 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 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status |
|---|---|---|---|---|
| NCT01649180 | Phase II | Axitinib | NEXT: Subsequent Exposure to Tyrosine Kinase Inhibition at Recurrence After Adjuvant Therapy in Renal Cell Carcinoma (PrE0801) | Terminated |
| NCT02560012 | Phase II | Everolimus Sorafenib Temsirolimus Axitinib Sunitinib Pazopanib | Personalized Targeted Inhibitors Treatment in Renal Cell Cancer | Terminated |
| 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) (CAPTUR) | Recruiting |
| NCT03839498 | Phase II | Axitinib | Study of Axitinib (AG-013736) With Evaluation of the VEGF-pathway in Pheochromocytoma/Paraganglioma | Recruiting |
| NCT01540526 | Phase I | Axitinib | Pharmacodynamic Study With FLT-PET/CT in Patients With Prostate/Other Solid Malignancies Treated With High Dose Axitinib | Completed |
| NCT01599754 | Phase III | Axitinib | Adjuvant Axitinib Therapy of Renal Cell Cancer in High Risk Patients | Terminated |
| NCT01727336 | Phase II | Axitinib + Dalantercept Axitinib | Study of Dalantercept in Patients With Advanced Renal Cell Carcinoma | Completed |
| NCT01508117 | Phase II | Axitinib | Phase II Axitinib (AG-013736) in Elderly Glioblastoma Multiforme (GBM) Patients | Terminated |
| NCT02639182 | Phase II | AGS16F Axitinib | A Study of AGS-16C3F vs. Axitinib in Metastatic Renal Cell Carcinoma | Active, not recruiting |
| NCT02164838 | Phase I | Axitinib | VEGF Receptor Tyrosine Kinase Inhibitor Axitinib in Children With Recurrent or Refractory Solid Tumors | Completed |
| 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 | Recruiting |
| 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 | Active, not recruiting |
| NCT00828919 | Phase I | Axitinib | Continuing Access To AG- 013736 (A406) For Patients Previously Receiving AG 013736 In Clinical Trials | Active, not recruiting |
| NCT02579811 | Phase II | Axitinib | Axitinib Given on an Individualized Schedule for Metastatic Renal Cell Cancer | Active, not recruiting |
| NCT03595124 | Phase II | Nivolumab Axitinib + Nivolumab Axitinib | Axitinib and Nivolumab in Treating Participants With Unresectable or Metastatic TFE/Translocation Renal Cell Carcinoma | Recruiting |
| NCT01321437 | Phase II | Axitinib | Study of the Anti-Angiogenesis Agent Axitinib in Patients With Stage III Malignant Melanoma | Active, not recruiting |
| NCT02667886 | Phase Ib/II | Axitinib X4P-001 | Trial of X4P-001 in Patients With Advanced Renal Cell Carcinoma | Active, not recruiting |
| NCT03438708 | Phase II | Axitinib | Prior Axitinib as a Determinant of Outcome of Renal Surgery (PADRES) | Unknown status |
| NCT01409200 | Phase II | Axitinib | Neoadjuvant Axitinib in Prostate Cancer | Active, not recruiting |
| NCT01533948 | Phase II | Axitinib | Axitinib in Treating Patients With Melanoma That is Metastatic or Cannot Be Removed By Surgery | Terminated |
| NCT02762513 | Phase II | Axitinib | Expansion Trial for Axitinib In Head And Neck Cancer | Active, not recruiting |
| 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 |
| NCT03092856 | Phase II | Axitinib Axitinib + PF-04518600 | Axitinib With or Without Anti-OX40 Antibody PF-04518600 in Treating Patients With Metastatic Kidney Cancer | Recruiting |
| NCT02129647 | Phase II | Axitinib | Study of Axitinib in Patients With Neurofibromatosis Type 2 and Progressive Vestibular Schwannomas | Active, not recruiting |
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