Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Utidelone; capecitabine · 1 trial · 1 indication
To measure the maximal plasma concentration of the study drugs and evaluate the pharmacokinetic characteristics of continuous intravenous administration of utidelone, measure PK parameters such as Maximum Plasma Concentration \[Cmax\]
To evaluate the pharmacokinetic interaction of utidelone and capecitabine in patients when administered in combination.
To get area under the plasma concentration versus time curve
| Arm | Type | Description |
|---|---|---|
| Utidelone | EXPERIMENTAL | - |
| Utidelone plus capecitabine | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Utidelone Injection; capecitabine | DRUG | 8 patients will be assigned to utidelone plus capecitabine arm receiving utidelone plus capecitabine. Utidelone injection 30mg/m2/day, intravenously administered once a day for 5 consecutive days; capecitabine tablets, 1000mg/m2, orally, 2 times a day for 14 consecutive days. 21 days is a cycle |
| Utidelone | DRUG | 8 patients will be assigned to utidelone arm and receive utidelone injection 30 mg/m2/day intravenously, once a day for 5 consecutive days in a 21-day cycle. |
Inclusion Criteria: 1. Voluntarily sign an informed consent form, have good compliance, and cooperate with relevant inspections. 2. Histologically and/or cytologically diagnosed patients with advanced, metastatic breast cancer. 3. Patients who have previously received at least one anthracycline and...
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