NCT03135951

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Spectrum Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 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.

Conditions

• Breast Cancer
• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	SPI-2012	Supplied in prefilled, single-use syringes for subcutaneous injection and administered on Day 2 of each cycle.

Timeline

• Start date: 2017-05-11
• Primary completion: 2018-02-19
• Completion: 2018-05-18
• First posted: 2017-05-02
• Last updated: 2020-11-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study