Claims for Patent: 11,504,365
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Summary for Patent: 11,504,365
| Title: | Use of tivozanib to treat subjects with refractory cancer |
| Abstract: | Disclosed is a method of treating cancer, e.g., refractory cancer, with tivozanib. The methods disclosed include, for example, administering tivozanib as a second or third-line therapy to subjects suffering from refractory advanced renal cell carcinoma where traditional therapies as well as more recent targeted and immune-oncology therapies have not adequately treated the subject. |
| Inventor(s): | Michael P. Bailey, Michael N. Needle |
| Assignee: | Aveo Pharmaceuticals Inc |
| Application Number: | US17/720,619 |
| Patent Claims: |
1. A method of treating a human subject with refractory advanced renal cell carcinoma (RCC) having previously received at least two anti-cancer therapies, at least one of which included a tyrosine kinase inhibitor (TKI), the method comprising: administering to the subject treatment cycles consisting essentially of: orally administering a pharmaceutical composition comprising an active agent consisting essentially of 1.5 mg tivozanib hydrochloride daily for 21 days followed by 7 days without administration of tivozanib hydrochloride until the subject experiences moderate hepatic impairment, upon which the amount of tivozanib hydrochloride in each treatment cycle is reduced from 1.5 mg to 1.0 mg, thereby to achieve a progression free survival in the subject of at least 5 months. 2. The method of claim 1, wherein the at least two anti-cancer therapies include a first line anti-cancer therapy and a second line anti-cancer therapy. 3. The method of claim 2, wherein the first line and second line anti-cancer therapies both include a vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR TKI) therapy. 4. The method of claim 2, wherein the first line and second line anti-cancer therapies include a VEGFR TKI therapy and a PD-1 or PD-L1 inhibitor therapy. 5. The method of claim 2, wherein first line and second line anti-cancer therapies include a VEGFR TKI therapy and a systemic anti-cancer agent. 6. The method of claim 1, wherein the subject is identified as having an International Metastatic-RCC Database Consortium (IMDC) risk score of favorable or intermediate prior to treatment of the subject. 7. A method of treating a human subject with refractory advanced renal cell carcinoma (RCC) having previously received at least two anti-cancer therapies, at least one of which included a tyrosine kinase inhibitor (TKI), and experiencing moderate hepatic impairment, the method comprising: administering to the subject one or more treatment cycles consisting essentially of: orally administering a pharmaceutical composition comprising an active agent consisting essentially of 1.0 mg tivozanib hydrochloride daily for 21 days followed by 7 days without administration of tivozanib hydrochloride, thereby to treat the RCC. 8. The method of claim 7, wherein the at least two anti-cancer therapies include a first line anti-cancer therapy and a second line anti-cancer therapy. 9. The method of claim 8, wherein the first line and second line anti-cancer therapies both include a vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR TKI) therapy. 10. The method of claim 8, wherein the first line and second line anti-cancer therapies include a VEGFR TKI therapy and a PD-1 or PD-L1 inhibitor therapy. 11. The method of claim 8, wherein first line and second line anti-cancer therapies include a VEGFR TKI therapy and a systemic anti-cancer agent. 12. The method of claim 7, wherein the subject is identified as having an International Metastatic-RCC Database Consortium (IMDC) risk score of favorable or intermediate prior to treatment of the subject. |
