Phase 2 Study of HM10460A or Pegfilgrastim Use for the Management of Neutropenia in Breast Cancer Patients

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the effect of test doses of HM10460A on the duration of severe neutropenia (DSN) during Cycle 1 in patients with breast cancer who are candidates for adjuvant or neoadjuvant chemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Histologically confirmed breast cancer who is a candidate for adjuvant or neoadjuvant chemotherapy

• Candidate for docetaxel and cyclophosphamide chemotherapy

• Female or male ≥ 18 years of age

• ECOG ≤ 2

• ANC ≥ 1.5 x 10^9/L

• Platelet count ≥ 100 x 10^9/L

• Creatinine ≤ 1.5 x upper limit of normal (ULN)

• Total bilirubin ≤ 1.5 mg/dL (≤ 25.65 μmol/L)

• AST/SGOT and/or ALT/SGPT ≤ 2.5 x ULN

• Hemoglobin > 9 g/dL

• Alkaline phosphatase ≤ 1.5 x ULN

Exclusion Criteria:

• Known sensitivity to E. coli derived products or known sensitivity to any of the products to be administered during dosing

• Known HIV infection

• HBV or HCV diagnosis with detectable viral load or immunological evidence of chronic active disease

• Active infection or any serious underlying medical condition, which would impair the ability of the patient to receive protocol treatment

• Prior bone marrow or stem cell transplant

• Prolonged exposure to glucocorticosteroids and immunosuppressive agents