(12) United States Patent (10) Patent No.: US 7,732.491 B2

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(12) United States Patent (10) Patent No.: US 7,732.491 B2 US007732491 B2 (12) UnitedO States Patent (10) Patent No.: US 7,732.491 B2 Sherman et al. (45) Date of Patent: Jun. 8, 2010 (54) TREATMENT OF BREAST CANCER WITH A 5,516,941 A 5/1996 Kun et al. PARP INHIBITOR ALONE OR IN 5,519,053 A 5/1996 Kun et al. COMBINATION WITH ANT-TUMIOR 5,583,155 A 12/1996 Kun et al. AGENTS 5,631,038 A 5/1997 Kurtz et al. 5,631,231 A 5/1997 Kurtz et al. (75) Inventors: Barry M. Sherman, Hillsborough, CA E. 2. I al (US); Charles Bradley, Half Moon Bay, 5,631,252 A 5/1997 Kurtz et al. CA (US); Valeria S. Ossovskaya, San 5,631,272 A 5/1997 Kurtz et al. Francisco, CA (US) 5,631,292 A 5/1997 Kurtz et al. 5,631,294 A 5/1997 Kurtz et al. (73) Assignee: BiPar Sciences, Inc., Brisbane, CA (US) 5,631,295 A 5/1997 Kurtz et al. 5,631,299 A 5/1997 Kurtz et al. (*) Notice: Subject to any disclaimer, the term of this 5,633,282 A 5/1997 Collins et al. patent is extended or adjusted under 35 5,637,618 A 6/1997 Kurtz et al. U.S.C. 154(b) by 0 days. 5,639,788 A 6/1997 Kurtz et al. 5,641,795. A 6/1997 Kurtz et al. 5,641,799 A 6/1997 Kurtz et al. (21) Appl. No.: 12/269,024 5,641,811 A 6/1997 Kurtz et al. 1-1. 5,641,812 A 6/1997 Kurtz et al. (22) Filed: Nov. 11, 2008 5,643,894. A 7/1997 Kurtz et al. O O 5,643,941 A 7/1997 Kurtz et al. (65) Prior Publication Data 5,643,945. A 7/1997 Kurtz et al. US 2009/0131529 A1 May 21, 2009 5,643,955. A 7/1997 Kurtz et al. 5,643,956 A 7/1997 Kurtz et al. Related U.S. Application Data 5,646,122 A 7/1997 Kurtz et al. (60) Provisional application No. 60/987,333, filed on Nov. (Continued) 12, 2007, provisional application No. 61/012,364, filed on Dec. 7, 2007, provisional application No. FOREIGN PATENT DOCUMENTS 61/058,528, filed on Jun. 3, 2008. CN 1768732 A S/2006 (51) Int. Cl. (Continued) A6 IK3I/I66 2006.O1 (52) U.S. Cl ( ) S14f619 OTHER PUBLICATIONS (58) Field of Classification Search .................. 514f619 Dent et al. Clin. Cancer Res., 2007, vol. 13, No. 15, pp. 4429-4434.* See application file for complete search history. Cleator et al. Lancet Oncol., 2007, vol. 8, pp. 235-244.* Irvin et al. European Journal of Cancer, 2008, vol. 44, pp. 2799 (56) References Cited 2805.* DeSoto et al. International Journal of Medical Sciences, 2006, vol. 3, U.S. PATENT DOCUMENTS No. 4, pp. 117-123.* 2006.735. A 7, 1935 Fischer at all Donawho et al. Clin. Cancer Res., 2007, vol. 13, No. 9, pp. 2728 2737.* 2S25 A 38. inal Ausubel, et al. Current Protocols of Molecular Biology, John Wiley 3,161,564. A 12/1964 Morehouse and Sons (1997). 3.228,833. A 1, 1966 Crounseat al. Ayhan, his Topotecan as t Second-line E. with 4 4-w ovarian and primary peritoneal cancer: initial response and long-term s: A 8. My et al. follow-up. Eur J. 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In another aspect, the present invention 5.464.87 1 A 11/1995 Kun et all provides a method of treating breast cancer comprising 5.473,074 A 12/1995 Kunet al. administering to a subject at least one PARP inhibitor in 5482,833 A 1/1996 Pero et al. combination with at least one anti-tumor agent. 5,482.975 A 1/1996 Kun et al. 5,484.951 A 1/1996 Kun et al. 10 Claims, 6 Drawing Sheets US 7,732.491 B2 Page 2 U.S. PATENT DOCUMENTS 2005/0059824 A1 3/2005 Vaidyanathan et al. 2005, 0080.096 A1 4, 2005 Ishida et al. 5,650,403 A 7, 1997 Kurtz et al. 2005/0113283 A1 5/2005 Solow-Cordero et al. 5,652,260 A 7, 1997 Kun et al. 2005/017103.6 A1 8/2005 Arakawa et al. 5,652,367 A 7, 1997 Kun et al. 2005/0171101 A1 8/2005 Yamamoto et al. 5,654,311 A 8, 1997 Kurtz et al. 2005/0227919 A1 10, 2005 Ashworth et al. 5,665,755 A 9, 1997 Kurtz et al. 2005/0287120 A1 12/2005 Fisher et al. 5,670,518 A 9, 1997 Kun et al. 2006, OO63767 A1 3, 2006 Javaid et al. 5,700,792 A 12/1997 Kurtz et al. 2006/0074073 A1 4/2006 Steinfeldt et al. 5,703,053 A 12/1997 Kurtz et al. 2006/0094676 A1 5.2006 Lahav et al. 5,719,151 A 2f1998 Shall et al. 2006/0100198 A1 5.2006 Liu et al. 5,734,056 A 3, 1998 Burk et al. 2006/0229289 A1 10, 2006 Zhu et al. 5,736,576 A 4, 1998 Kun et al. 2006/0229.351 A1 10, 2006 Zhu et al. 5,753,674. 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