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



Status:Completed
Conditions:Breast Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:5/5/2014
Start Date:January 2013
End Date:December 2014
Contact:Dennis Kim, MD, MPH
Email:Dennis.Kim@sppirx.com
Phone:(949) 743-9229

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Phase 2, Open-Label, Dose-Ranging Study of HM10460A or Pegfilgrastim Use for the Management of Neutropenia in Patients With Breast Cancer Who Are Candidates for Adjuvant and Neoadjuvant Chemotherapy With the Docetaxel + Cyclophosphamide (TC) Regimen

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.

This is an open label, multicenter, dose ranging study, sequentially enrolled by study dose,
with a non-inferiority design to compare the effectiveness of HM10460A relative to a fixed
dose of pegfilgrastim as a concurrent active control to each dose of HM10460A in patients
with breast cancer. The study will include 4 arms: 3 dose levels of HM10460A versus
pegfilgrastim. The start of study treatment is defined as the initiation of HM10460A or
pegfilgrastim. The duration of treatment consists of a maximum of 4 cycles, which begin on
Day 1 with chemotherapy administration and continue through Day 21.

The planned number of patients is a total of 144 based on 36 enrolled into each of 4
treatment arms. The target population are patients with breast cancer who are candidates for
neoadjuvant or adjuvant treatment with TC chemotherapy. All patients who receive at least 1
dose of either HM10460A or pegfilgrastim will be followed for safety through 20 (± 2) days
after their last dose of study treatment or until all treatment-related AEs have resolved or
returned to baseline/Grade 1, whichever is longer, or until it is determined that the
outcome will not change with further follow-up.

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
We found this trial at
20
sites
Albany, New York 12206
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Athens, Georgia 30607
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Athens, GA
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Boynton Beach, Florida 33426
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Burbank, California 91505
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Burbank, CA
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3100 Plaza Properties Blvd
Columbus, Ohio 43219
(614) 383-6000
The Mark H. Zangmeister Center At The Zangmeister Center, we appreciate that our patients have...
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Columbus, OH
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Corvallis, Oregon 97330
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Corvallis, OR
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Fresno, CA
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Glendale, Arizona 85306
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Hazard, Kentucky 41701
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Highland, California 92346
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Highland, CA
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Los Angeles, CA
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Oceanside, California 92056
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Oceanside, CA
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Orange, California 92868
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Orange, CA
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Palm Springs, CA
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Santa Monica, California 90403
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Santa Monica, CA
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Scottdale, Arizona 85255
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Scottdale, AZ
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Setauket, NY
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Skokie, Illinois 60076
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221 N Grand Blvd
St. Louis, Missouri 63103
(800) 758-3678
Saint Louis University Saint Louis University is a Catholic, Jesuit institution with campuses in St....
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Whittier, California 90603
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Whittier, CA
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