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This study is being performed to confirm the safety of tesetaxel 27 mg/m2 (Day 1) in combination with capecitabine 2000/mg/m2/day (in 2 equally divided doses on Days 1 through 14) in a 21-day cycle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tesetaxel-capecitabine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tesetaxel plus capecitabine | Drug | Study medication, which will include tesetaxel capsules and capecitabine tablets, will be administered orally for two 21-day cycles. In each cycle, tesetaxel will be administered at a dose of 27 mg/m2 on Day 1, and capecitabine will be administered in Cohort 1 at a dose of 2000 mg/m2/day and in Cohort 2 at a dose of 1750 mg/m2/day (in 2 equally divided doses) on Day 1 through Day 14. At the conclusion of Cycle 2, patients who, in the opinion of the investigator, appear to have benefitted from protocol therapy may receive up to 6 additional cycles under a separate protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Percentage of subjects with adverse events | Through 30 days following the last dose of study medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lee S Schwartzberg, MD, FACP | The West Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The West Clinic | Memphis | Tennessee | 38120 | United States |
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| ID | Term |
|---|---|
| C479543 | tesetaxel |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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|
|
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |