Methods of treating melanoma

Patent metadata

Field	Value
Publication number	US-2016228401-A1
Application number	US-201514835458-A
Country	US
Kind code	A1
Filing date	Aug 25, 2015
Priority date	Nov 9, 2012
Publication date	Aug 11, 2016
Grant date	—

Abstract

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

First claim

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.

Assignees

• Abraxis Bioscience Llc

Inventors

• Desai Neil P
• Renschler Markus

Classifications

• A61P35/00

  Antineoplastic agents · CPC title

• A61K31/337 Primary

  having four-membered rings, e.g. taxol · CPC title

• A61K9/5169

  Proteins, e.g. albumin, gelatin · CPC title

• C07K16/3053

  Skin, nerves, brain · CPC title

• A61K9/0019

  Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00) · CPC title