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

Completed · Phase 1

Conditions studied: Breast Cancer, Pharmacokinetics

In brief

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.

Key facts

Study ID

NCT03135951

Run by

Spectrum Pharmaceuticals, Inc

People needed

26

Starts

2017-05-11

Expected to finish

2018-05-18

Last updated by the study team

2020-11-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Newly diagnosed, histologically confirmed early-stage breast cancer, defined as operable Stage I to Stage IIIA breast cancer.
• Candidate to receive adjuvant or neoadjuvant TC chemotherapy.
• ANC ≥1.5x10\^9/L
• Platelet count ≥100x10\^9/L
• Hemoglobin >9 g/dL
• Calculated creatinine clearance >50 mL/min
• Total bilirubin ≤1.5 mg/dL
• AST and ALT ≤2.5xULN
• Alkaline phosphatase ≤2.0xULN
• ECOG ≤2

You may not qualify if…

• Active concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of cervix) or life-threatening disease. If history of prior malignancies or contralateral breast cancer, must be disease free for at least 5 years.
• Known sensitivity to E. coli derived products or known sensitivity to any of the products to be administered during dosing.
• Concurrent adjuvant cancer therapy.
• Locally recurrent/metastatic breast cancer.
• Previous exposure to filgrastim, pegfilgrastim, or other G-CSF products in clinical development within 12 months prior to the administration of study drug.
• Active infection, receiving antibiotics or any serious underlying medical condition which would impair the ability of the patient to receive protocol-specified treatment.
• Prior bone marrow or hematopoietic stem cell transplant
• Used any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study.
• Prior radiation therapy within 30 days prior to enrollment.
• Major surgery within 30 days prior to enrollment.

Where it is running

• Research Center — Anaheim, California, United States

Full record on ClinicalTrials.gov

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