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Details for Patent: 8,877,771

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Details for Patent: 8,877,771

Title:Treatment of solid tumors with rapamycin derivatives
Abstract: The present invention is directed to the use of rapamycin derivatives for use in treating solid tumors, optionally in combination with a chemotherapeutic agent.
Inventor(s): Lane; Heidi (Basel, CH), O'Reilly; Terence (Basel, CH), Wood; Jeanette Marjorie (Biel-Benken, CH)
Assignee: Novartis Pharmaceuticals Corporation (East Hanover, NJ)
Filing Date:Jun 27, 2013
Application Number:13/928,891
Claims:1. A method for inhibiting growth of solid tumors of the breast in a subject having a solid breast tumor, said method consisting of: administering to said subject a therapeutically effective amount of 40-O-(2-hydroxyethyl)-rapamycin, which has the structure of a compound of formula I ##STR00002## wherein R.sub.1 is CH.sub.3, R.sub.2 is --CH.sub.2--CH.sub.2--OH, and X is .dbd.O, wherein said compound of formula I is adminstered concomitantly or sequentially with letrozole.

2. The method of claim 1 wherein the solid tumor of the breast has metastasized.

3. The method of claim 1 wherein the compound of formula I is administered orally.

4. The method of claim 1 wherein the compound of formula I is administered at a daily dose range of from about 0.1 to 25 mg, as a single dose or in divided doses.

5. The method of claim 1 wherein the compound of formula I is administered in a unit dosage form of from about 0.05 to 12.5 mg.

6. The method of claim 5 wherein the compound of formula I is administered in a unit dosage form of from about 0.25 to 10 mg.

7. The method of claim 6 wherein the compound of formula I is administered in a unit dosage form of 10 mg.

8. The method of claim 1 wherein the letrozole is administered in a dosage range from about 0.5 to about 10 mg/day.

9. The method of claim 1 wherein the letrozole is administered in a dosage range from about 1 to about 2.5 mg/day.

10. The method of claim 1 wherein the compound of formula I is administered in a unit dosage form of 10 mg and the letrozole is administered in a dose of 2.5 mg.

11. The method of claim 1 wherein the tumor is a hormone receptor positive tumor.

12. A method for treating solid tumors of the breast in a subject having a solid breast tumor, said method consisting of: administering to said subject a therapeutically effective amount of 40-O-(2-hydroxyethyl)-rapamycin, which has the structure of a compound of formula I ##STR00003## wherein R.sub.1 is CH.sub.3, R.sub.2 is --CH.sub.2--CH.sub.2--OH, and X is .dbd.O, wherein said compound of formula I is adminstered concomitantly or sequentially with letrozole.

13. The method of claim 12 wherein the solid tumor of the breast has metastasized.

14. The method of claim 12 wherein the compound of formula I is administered orally.

15. The method of claim 12 wherein the compound of formula I is administered at a daily dose range of from about 0.1 to 25 mg, as a single dose or in divided doses.

16. The method of claim 12 wherein the compound of formula I is administered in a unit dosage form of from about 0.05 to 12.5 mg.

17. The method of claim 16 wherein the compound of formula I is administered in a unit dosage form of from about 0.25 to 10 mg.

18. The method of claim 17 wherein the compound of formula I is administered in a unit dosage form of 10 mg.

19. The method of claim 12 wherein the letrozole is administered in a dosage range from about 0.5 to about 10 mg/day.

20. The method of claim 12 wherein the letrozole is administered in a dosage range from about 1 to about 2.5 mg/day.

21. The method of claim 12 wherein the compound of formula I is administered in a unit dosage form of 10 mg and the letrozole is administered in a dose of 2.5 mg.

22. The method of claim 12 wherein the tumor is a hormone receptor positive tumor.
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