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 |
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.
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.
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
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The Mark H. Zangmeister Center At The Zangmeister Center, we appreciate that our patients have...
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Saint Louis University Saint Louis University is a Catholic, Jesuit institution with campuses in St....
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