US2016228401A1PendingUtilityA1

Methods of treating melanoma

Assignee: ABRAXIS BIOSCIENCE LLCPriority: Nov 9, 2012Filed: Aug 25, 2015Published: Aug 11, 2016
Est. expiryNov 9, 2032(~6.3 yrs left)· nominal 20-yr term from priority
A61P 35/00A61K 31/337A61K 9/5169C07K 16/3053A61K 9/0019C07K 16/2818A61K 39/39558A61K 39/395C07K 16/22A61K 2039/505
48
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Claims

Abstract

Provided herein are methods for the treatment of melanoma comprising administration of a composition comprising nanoparticles comprising taxane and a carrier protein.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A method of treating melanoma in a human individual comprising administering to the individual an effective amount of a composition comprising nanoparticles comprising paclitaxel and an albumin. 
     
     
         2 . The method of  claim 1 , wherein the individual is selected for treatment based on the individual having metastatic melanoma at stage M1c. 
     
     
         3 . The method of  claim 1 , wherein the individual is selected for treatment based on the individual having a serum LDH level of between greater than about 1.1× to about 2.0×ULN. 
     
     
         4 . The method of  claim 1 , wherein the individual is selected for treatment based on the individual having a melanoma comprising wild-type BRAF. 
     
     
         5 . The method of  claim 1 , wherein the individual is selected for treatment based on the individual having a melanoma comprising a mutation in BRAF. 
     
     
         6 . The method of  claim 7 , wherein the mutation in BRAF is a V600E mutation in BRAF. 
     
     
         7 . The method of  claim 1 , wherein the method further comprises a second therapy. 
     
     
         8 . The method of  claim 7 , wherein the method comprises administration of at least one other therapeutic agent. 
     
     
         9 . The method of  claim 8 , wherein the other therapeutic agent is a BRAF inhibitor. 
     
     
         10 . The method of  claim 8 , wherein the other therapeutic agent is Ipilimumab. 
     
     
         11 . The method of  claim 1 , wherein the method is used as a first line therapy. 
     
     
         12 . The method of  claim 1 , wherein the method is used as a second line therapy. 
     
     
         13 . The method of  claim 1 , wherein the composition comprising nanoparticles comprising paclitaxel and an albumin is administered intravenously. 
     
     
         14 . The method  claim 1 , wherein the dose of paclitaxel in the nanoparticle composition is about 80 mg/m 2  to about 200 mg/m 2 . 
     
     
         15 . The method of  claim 1 , wherein the dose of paclitaxel in the nanoparticle composition is about 150 mg/m 2 . 
     
     
         16 . The method of  claim 1 , wherein the composition comprising nanoparticles comprising paclitaxel and an albumin is administered weekly. 
     
     
         17 . The method of  claim 16 , wherein the composition comprising nanoparticles comprising paclitaxel and an albumin is administered on days 1, 8, and 15 of the 28-day treatment cycle. 
     
     
         18 . The method of  claim 1 , wherein the albumin is human serum albumin. 
     
     
         19 . The method of  claim 1 , wherein the nanoparticles in the composition have an average diameter of no greater than about 200 nm. 
     
     
         20 . The method of  claim 1 , wherein the weight ratio of albumin and paclitaxel in the nanoparticle composition is about 9:1 or less. 
     
     
         21 . The method of  claim 1 , wherein the paclitaxel in the nanoparticles are coated with the albumin. 
     
     
         22 . A kit comprising (i) a composition comprising nanoparticles comprising paclitaxel and an albumin, and (ii) an instruction for administering the nanoparticle composition for treating melanoma.

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