Spots Global Cancer Trial Database for A PK Study of Oraxol in Breast Cancer Patients

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Trial Identification

Brief Title: A PK Study of Oraxol in Breast Cancer Patients

Official Title: A Clinical Study to Determine the Pharmacokinetics of Oraxol in Breast Cancer Patients

Study ID: NCT04993040

Conditions

Breastcancer

Interventions

Oraxol

Study Description

Brief Summary: This is a multicenter, open-label, single-arm PK study in approximately 24 breast cancer patients for whom paclitaxel treatment is indicated.

Detailed Description: This is a multicenter, open-label, single-arm PK study in approximately 24 breast cancer patients for whom paclitaxel treatment is indicated. The study contains 3 periods: the Screening / Baseline Period, the Treatment Period, and the Follow-up Period. A Final Visit will occur within 7 days of the last dose of study treatment. If subjects achieve stable disease (SD), partial response (PR), or complete response (CR) at the end of the Treatment Period, they may continue Oraxol treatment in a separate extension study.