Name | Type | Description | Interventions |
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Phase I Dose Level 1: ATI-450 + Capecitabine | Experimental | -Patients will receive ATI-450 by mouth (PO) twice per day (BID) along with standard chemotherapy capecitabine (1000 mg/m^2 PO BID on Days 1 through 14 of every 21-day cycle). In phase I, two dose levels of ATI-450 will be tested (dose level 1: 50 mg PO BID; dose level 2: 100 mg PO BID). For each chemotherapy cohort (paclitaxel and capecitabine), 6 patients will be enrolled at Dose Level 1. If no more than 1 of 6 patients at Dose Level 1 experiences a dose limiting toxicity (DLT), then 6 patients will be enrolled to Dose Level 2 for each chemotherapy cohort. | |
Phase I Dose Level 1: ATI-450 + Paclitaxel | Experimental | -Patients will receive ATI-450 by mouth (PO) twice per day (BID) along with standard chemotherapy paclitaxel (80 mg/m^2 intravenous (IV) weekly) of every 21-day cycle. In phase I, two dose levels of ATI-450 will be tested (dose level 1: 50 mg PO BID; dose level 2: 100 mg PO BID). For each chemotherapy cohort (paclitaxel and capecitabine), 6 patients will be enrolled at Dose Level 1. If no more than 1 of 6 patients at Dose Level 1 experiences a dose limiting toxicity (DLT), then 6 patients will be enrolled to Dose Level 2 for each chemotherapy cohort. | |
Phase I Dose Level 2: ATI-450 + Paclitaxel | Experimental | -Patients will receive ATI-450 by mouth (PO) twice per day (BID) along with standard chemotherapy paclitaxel (80 mg/m^2 intravenous (IV) weekly) of every 21-day cycle. In phase I, two dose levels of ATI-450 will be tested (dose level 1: 50 mg PO BID; dose level 2: 100 mg PO BID). For each chemotherapy cohort (paclitaxel and capecitabine), 6 patients will be enrolled at Dose Level 1. If no more than 1 of 6 patients at Dose Level 1 experiences a dose limiting toxicity (DLT), then 6 patients will be enrolled to Dose Level 2 for each chemotherapy cohort. | |
Phase I Dose Level 2: ATI-450 + Capecitabine | Experimental | -Patients will receive ATI-450 by mouth (PO) twice per day (BID) along with standard chemotherapy of capecitabine (1000 mg/m^2 PO BID on Days 1 through 14 of every 21-day cycle)). In phase I, two dose levels of ATI-450 will be tested (dose level 1: 50 mg PO BID; dose level 2: 100 mg PO BID). For each chemotherapy cohort (paclitaxel and capecitabine), 6 patients will be enrolled at Dose Level 1. If no more than 1 of 6 patients at Dose Level 1 experiences a dose limiting toxicity (DLT), then 6 patients will be enrolled to Dose Level 2 for each chemotherapy cohort. | |
Phase II Arm 1: ATI-450 (dose level 1) + chemotherapy | Experimental | -Patients will receive ATI-450 (dose level 1) by mouth (PO) twice per day (BID) along with standard chemotherapy (either paclitaxel (80 mg/m^2 intravenous (IV) weekly) or capecitabine (1000 mg/m^2 PO BID on Days 1 through 14 of every 21-day cycle)). The chemotherapy will be physician's decision. | - ATI-450
- Paclitaxel
- Capecitabine
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Phase II Arm 2: ATI-450 (dose level 2) + chemotherapy | Experimental | -Patients will receive ATI-450 (dose level 2) by mouth (PO) twice per day (BID) along with standard chemotherapy (either paclitaxel (80 mg/m^2 intravenous (IV) weekly) or capecitabine (1000 mg/m^2 PO BID on Days 1 through 14 of every 21-day cycle)). The chemotherapy will be physician's decision. | - ATI-450
- Paclitaxel
- Capecitabine
|
Phase II Arm 3: antiresorptive + chemotherapy | Active Comparator | -Antiresorptive = bisphosphonate or denosumab on a 21-day cycle | - Paclitaxel
- Capecitabine
- Antiresorptive Agents
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