Osi Pharmaceuticals, Inc.

Novartis Ag

Dana-farber-cancer Institute Inc.

Oregon Health & Science University

Novartis Pharma Gmbh

Sandra Leta Silberman

Richard D Connell

Timothy Norris

Jeffrey W Raggon

James Dale Moyer

Shama Kajiji

Michael J Morin

Barbara A Foster

Karen J Ferrante

Brian Jay Druker

Jonathan A Fletcher

Michael C Heinrich

George Daniel Demetri

Elisabeth Buchdunger

Heikki Joensuu

Renaud Capdeville

Sasa Dimitrijevic

David Tuveson

A method of monotherapy for a subject suffering from abnormal cell growth expressing the epidermal growth factor receptor (EGFR) which comprises orally administering to the subject a therapeutically effective amount of a crystalline polymorph of the hydrochloride salt of N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine so as to treat the subject.

Treating abnormal cell growth with a stable polymorph of N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine hydrochloride

4-(4-methylpiperazin-1-ylmethyl)-N-[4-methyl-3-(4-pyridin-3-yl)pyrimidin-2-ylamino)phenyl]-benzamide of the formula Ior a pharmaceutically acceptable salt thereof can be used in the treatment of gastrointestinal stromal tumours.

Treatment of gastrointestinal stromal tumors

The present invention relates to a stable crystalline form of N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine hydrochloride designated the B polymorph, its production in essentially pure form, and its use. The invention also relates to the pharmaceutical compositions containing the stable polymorph B form of N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine as hydrochloride, as well other forms of the compound, and to methods of treating hyperproliferative disorders, such as cancer, by administering the compound.

Stable polymorph on N-(3-ethynylphenyl)-6, 7-bis (2methoxyethoxy)-4-quinazolinamine hydrochloride, methods of production, and pharmaceutical uses thereof

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Randolph, NJ, United States of America

Sandra Leta Silberman