DOSING SCHEDULE FOR TESETAXEL AND CAPECITABINE
The present disclosure provides methods for treating a patient with cancer, such as metastatic breast cancer, comprising administering tesetaxel and capecitabine to the patient.
1 . A method of treating a cancer in a human patient, comprising:
administering tesetaxel on day 1 of a 21-day cycle; and
administering capecitabine daily on days 1-14 of the 21-day cycle.
2 . A method of treating a cancer in a human patient, comprising:
administering tesetaxel on day 1 of a 21-day cycle; and
administering capecitabine in 28 doses at twice-daily intervals beginning on day 1 of the 21-day cycle.
3 . The method of claim 2 , wherein each cycle comprises administering a first dose of capecitabine on day 1 of the 21-day cycle and administering a final 28 th dose on day 15 of the 21-day cycle.
4 . The method of any one of claims 1 - 3 , comprising repeating the 21-day cycle at least once.
5 . The method of any one of claims 1 - 3 , comprising repeating the 21-day cycle until the cancer progresses or until unacceptable toxicity is observed.
6 . The method of any one of the preceding claims, wherein administering tesetaxel comprises administering 18-31 mg/m 2 of tesetaxel on day 1 of the 21-day cycle.
7 . The method of any one of the preceding claims, wherein administering tesetaxel comprises administering 27 mg/m 2 of tesetaxel on day 1 of the 21-day cycle.
8 . The method of any one of the preceding claims, wherein administering capecitabine comprises administering capecitabine twice daily on days 1-14 of the 21-day cycle.
9 . The method of any one of the preceding claims, wherein administering capecitabine comprises administering 300-2,000 mg/m 2 of capecitabine on days 1-14 of the 21-day cycle.
10 . The method of any one of claims 1 - 9 , wherein administering capecitabine comprises administering 1,650 mg/m 2 of capecitabine on days 1-14 of the 21-day cycle.
11 . The method of claim 10 , wherein administering capecitabine comprises administering 825 mg/m 2 of capecitabine twice daily on days 1-14 of the 21-day cycle.
12 . The method of any one of claims 1 - 9 , wherein administering capecitabine comprises administering 1,750 mg/m 2 of capecitabine on days 1-14 of the 21-day cycle.
13 . The method of claim 12 , wherein administering capecitabine comprises administering 875 mg/m 2 of capecitabine twice daily on days 1-14 of the 21-day cycle.
14 . The method of any one of the preceding claims, wherein administering capecitabine comprises administering 28 doses of 150-1,000 mg/m 2 capecitabine at twice-daily intervals.
15 . The method of any one of the preceding claims, wherein administering capecitabine comprises administering 28 doses of 150-1,000 mg/m 2 of capecitabine at twice-daily intervals beginning with the first dose on day 1 of the 21-day cycle and ending with the 28 th dose on day 15 of the 21-day cycle.
16 . The method of claim 14 or 15 , wherein administering capecitabine comprises administering 28 doses of 825 mg/m 2 capecitabine at twice-daily intervals.
17 . The method of claim 16 , wherein administering capecitabine comprises administering 28 doses of 825 mg/m 2 of capecitabine at twice-daily intervals beginning with the first dose on day 1 of the 21-day cycle and ending with the 28 th dose on day 15 of the 21-day cycle.
18 . The method of claim 14 or 15 , wherein administering capecitabine comprises administering 28 doses of 875 mg/m 2 capecitabine at twice-daily intervals.
19 . The method of claim 18 , wherein administering capecitabine comprises administering 28 doses of 875 mg/m 2 of capecitabine at twice-daily intervals beginning with the first dose on day 1 of the 21-day cycle and ending with the 28 th dose on day 15 of the 21-day cycle.
20 . The method of any one of the preceding claims, wherein the patient has previously been treated with a taxane.
21 . The method of claim 20 , wherein the patient has previously been treated with a taxane in the neoadjuvant or adjuvant setting.
22 . The method of claim 20 or 21 , wherein the taxane is paclitaxel, docetaxel or albumin-bound paclitaxel.
23 . The method of any one of the preceding claims, wherein the cancer is breast cancer.
24 . The method of any one of the preceding claims, wherein the cancer is locally advanced or metastatic breast cancer.
25 . The method of claim 24 , wherein the cancer is locally advanced breast cancer.
26 . The method of claim 24 , wherein the cancer is metastatic breast cancer.
27 . The method of any one of claims 23 - 26 , wherein the breast cancer is hormone receptor positive.
28 . The method of any one of claims 23 - 27 , wherein the patient has previously received endocrine therapy.
29 . The method of any one of claims 23 - 28 , wherein the breast cancer is estrogen receptor positive.
30 . The method of any one of claims 23 - 29 , wherein the breast cancer is progesterone receptor positive.
31 . The method of any one of claims 23 - 30 , wherein the breast cancer is HER2-negative.
32 . The method of any one of claims 23 - 30 , wherein the breast cancer is hormone receptor positive and HER2-negative.