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ANTINEOPLASTIC COMBINATIONS WITH mTOR INHIBITOR, TRASTUZUMAB, AND/OR HKI-272

a technology of mtor inhibitors and combinations, applied in the direction of antibody medical ingredients, extracellular fluid disorders, metabolic disorders, etc., can solve the problems of delayed tumor progression or tumor recurrence tim

Inactive Publication Date: 2009-12-03
WYETH LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Temsirolimus exhibits cytostatic, as opposed to cytotoxic properties, and may delay the time to progression of tumors or time to tumor recurrence.

Method used

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  • ANTINEOPLASTIC COMBINATIONS WITH mTOR INHIBITOR, TRASTUZUMAB, AND/OR HKI-272
  • ANTINEOPLASTIC COMBINATIONS WITH mTOR INHIBITOR, TRASTUZUMAB, AND/OR HKI-272
  • ANTINEOPLASTIC COMBINATIONS WITH mTOR INHIBITOR, TRASTUZUMAB, AND/OR HKI-272

Examples

Experimental program
Comparison scheme
Effect test

example 1

Combination Regimen of Temsirolimus (CCI-779) and Trastuzumab in Treatment of Neoplasms

[0073]Dosing begins at month 1, day 1 with weekly intravenous (IV) temsirolimus and trastuzumab (IV) at the dosages provided below.

[0074]Temsirolimus and trastuzumab can be administered simultaneously, consecutively, or on alternative days.

[0075]Temsirolimus is administered IV weekly over a 30-minute period using an in-line filter and an automatic dispensing pump. Optionally, antihistamine (diphenhydramine, 25 to 50 mg IV or the equivalent) is administered about 30 minutes prior to temsirolimus infusion.

[0076]A trastuzumab loading dose is administered IV weekly over a 90 minute period. Weekly doses are administered, which are typically half the amount of the loading dose. For example, a 4 mg / kg loading dose is typically followed by 2 mg / kg weekly doses. These amounts may be adjusted. In one embodiment, no loading dose is required and the same dose is administered throughout the course of treatment...

example 2

Use of a Combination Regimen of HKI-272 and Temsirolimus (CCI-779) in Treatment of Neoplasms

[0078]Dosing begins at month 1, day 1 with daily HKI-272 and weekly intravenous (IV) temsirolimus at the dosages provided below.

[0079]On month 1, day 1, HKI-272 is administered orally prior to temsirolimus. Temsirolimus is administered following HKI-272, preferably within 30 minutes.

[0080]Temsirolimus is administered IV weekly over a 30-minute period using an in-line filter and an automatic dispensing pump. Optionally, antihistamine (diphenhydramine, 25 to 50 mg IV or the equivalent) is administered about 30 minutes prior to temsirolimus infusion.

[0081]Thereafter, HKI-272 is taken orally once daily with food, preferably in the morning.

HKI-272 (mg)Temsirolimus Dose (mg)80151602524050

[0082]Dose adjustments and / or delays for HKI-272 and temsirolimus are permitted. For example, treatment may continue as described herein for six months, with daily doses of HKI-272 and weekly doses of temsirolimus....

example 3

Use of a Combination Regimen of HKI-272, Temsirolimus (CCI-779), and Trastuzumab in Treatment of Neoplasms

[0083]Dosing begins at month 1, day 1 with daily HKI-272 and weekly intravenous (IV) temsirolimus and trastuzumab (IV) at the dosages provided below.

[0084]On month 1, day 1, HKI-272 is administered orally prior to temsirolimus. Temsirolimus and trastuzumab are administered following HKI-272, preferably within 30 minutes.

[0085]Temsirolimus is administered IV weekly over a 30-minute period using an in-line filter and an automatic dispensing pump. Optionally, antihistamine (diphenhydramine, 25 to 50 mg IV or the equivalent) is administered about 30 minutes prior to temsirolimus infusion.

[0086]A trastuzumab loading dose is administered IV weekly over a 90 minute period. Weekly doses are administered, which are typically half the amount of the loading dose. For example, a 4 mg / kg loading dose is typically followed by 2 mg / kg weekly doses. These amounts may be adjusted. In one embodim...

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Abstract

A combination of temsirolimus and trastuzumab in the treatment of cancer is provided. A combination of temsirolimus and HKI-272 is provided. A combination of a trastuzumab and a HKI-272 is also provided. Regimens and kits for treatment of metastatic breast cancer, containing trastuzumab, temsirolimus and / or HKI-272, optionally in combination with other anti-neoplastic agents, or immune modulators are described.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a division of U.S. patent application Ser. No. 11 / 592,066, filed Nov. 2, 2006, which claims the benefit under 35 USC 119(e) of U.S. Provisional Patent Application No. 60 / 837,509, filed Aug. 14, 2006 (expired) and U.S. Provisional Patent Application No. 60 / 733,562, filed Nov. 4, 2005 (expired), which applications are incorporated herein by reference.BACKGROUND OF THE INVENTION[0002]This invention relates to the use of combinations of trastuzumab with an mTOR inhibitor and / or a HKI-272, for the treatment of neoplasms associated with overexpression or amplification of HER2.[0003]CCI-779, rapamycin 42-ester with 3-hydroxy-2-(hydroxymethyl)-2-methylpropionic acid, is an ester of rapamycin which has demonstrated significant inhibitory effects on tumor growth in both in vitro and in vivo models. This compound is now known generically under the name temsirolimus. The preparation and use of hydroxyesters of rapamycin, including...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K39/395A61P35/00
CPCA61K31/436A61K31/4709A61K31/4745A61K39/39558A61K45/06A61K31/337A61K2300/00A61P11/00A61P13/08A61P15/00A61P17/00A61P19/00A61P25/00A61P3/00A61P35/00A61P35/02A61P35/04A61P43/00A61P5/00A61P7/00A61K39/395
Inventor MOORE, LAURENCEZACHARCHUK, CHARLESRABINDRAN, SRIDHAR K.
Owner WYETH LLC
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