Last updated on January 2019

Pharmacokinetics of SPI-2012 (Eflapegrastim) in Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) Chemotherapy

Brief description of study

The purpose of this study is to evaluate the pharmacokinetic (PK) profile of a fixed dose of SPI-2012 in patients with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC) chemotherapy, as measured by the serum concentration of SPI-2012 on specific days following drug administration.

Detailed Study Description

This is a Phase 1, single-arm multicenter study to evaluate the PK and safety of SPI-2012 (a long acting myeloid growth factor) in breast cancer patients treated with TC chemotherapy.

Approximately 25 patients will be enrolled.

Each cycle will be 21 days and patients will receive 4 cycles of treatment with 2 additional cycles based on the investigator's discretion. On Day 1 of each cycle, patients will receive TC chemotherapy and on Day 2 of each cycle, patients will receive SPI-2012.

Pharmacokinetics will be evaluated only in Cycles 1 and 3.

Clinical Study Identifier: NCT03135951

Contact Investigators or Research Sites near you

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Thuy Le

Research Center
Anaheim, CA United States

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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