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

• Status: Completed
• Trial end date: 2018-05-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spectrum Pharmaceuticals, Inc
• Treatments: Cyclophosphamide; Docetaxel

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.