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Claims for Patent: 7,087,613

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Claims for Patent: 7,087,613

Title:Treating abnormal cell growth with a stable polymorph of N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine hydrochloride
Abstract: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.
Inventor(s): Norris; Timothy (Gales Ferry, CT), Raggon; Jeffrey W. (North Stonington, CT), Connell; Richard D. (East Lyme, CT), Moyer; James D. (East Lyme, CT), Morin; Michael J. (Waterford, CT), Kajiji; Shama M. (Mystic, CT), Foster; Barbara A. (Mystic, CT), Ferrante; Karen J. (East Greenwich, RI), Silberman; Sandra L. (Randolph, NJ)
Assignee: OSI Pharmaceuticals, Inc. (Melville, NY)
Application Number:10/992,266
Patent Claims: 1. A method of monotherapy for a subject suffering from abnormal cell growth expressing the epiderinal growth factor receptor (EGFR) which comprises orally administering to the subject a therapeutically effective amount of a homogenous crystalline polymorph of the hydrochloride salt of N-(3-ethynylphenyl)-6,7-bis (2-methoxyethoxy)-4-quinazolinamine designated the B polymorph that exhibits an X-ray powder diffraction pattern having characteristic peaks expressed in degrees 2-theta at approximately 6.26, 12.48, 13.39, 16.96, 20.20, 21.10, 22.98, 24.46, 25.14, and 26.91 so as to treat the subject, wherein the abnormal cell growth is brain cancer, squamous cell cancer, bladder cancer, gastric cancer, pancreatic cancer, hepatic cancer, glioblastoma multiforme breast cancer, head cancer, neck cancer, esophageal cancer, prostate cancer, colorectal cancer, lung cancer, renal cancer, kidney cancer, ovarian cancer, gynecological cancer, thyroid cancer, non-small cell lung cancer (NSCLC), refractory ovarian cancer, or head and neck cancer.

2. The method of claim 1, wherein the abnormal cell growth is non-small cell lung cancer (NSCLC).

3. The method of claim 1, wherein the abnormal cell growth is refractory ovarian cancer.

4. The method of claim 1, wherein the abnormal cell growth is head and neck cancer.

5. The method of claim 1, wherein the therapeutically effective amount is from about 0.001 to about 100 mg/kg/day.

6. The method of claim 1, wherein the therapeutically effective amount is from about 1 to about 35 mg/kg/day.

7. The method of claim 1, wherein the therapeutically effective amount is from about 1 to about 7000 mg/day.

8. The method of claim 1, wherein the therapeutically effective amount is from about 5 to about 2500 mg/day.

9. The method of claim 1, wherein the therapeutically effective amount is from about 5 to about 200 mg/day.

10. The method of claim 1, wherein the therapeutically effective amount is from about 25 to about 200 mg/day.

11. The method of claim 1, wherein the treatment is a palliative or neo-adjuvant/adjuvant monotherapy.

12. The method of claim 1, wherein the EGFR receptor is the EGFRvIII receptor.

13. The method of claim 1, wherein the therapeutically effective amount is from 100 to 1600 mg/week.

14. The method of claim 1, wherein the therapeutically effective amount is orally administered weekly.
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