Overview

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