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 + Cyclophophamide (TC) Regimen
18 Years
N/A
Female
Neutropenia
Trial Information
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 + Cyclophophamide (TC) Regimen
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 ≥ 18 years of age
- ECOG ≤ 2
- ANC ≥ 1.5 x 109/L
- Platelet count ≥ 100 x 109/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 ≤ 1.5 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Duration of severe neutropenia (DSN) in Cycle 1
Outcome Description:
DSN in Cycle 1, with severe neutropenia defined as ANC < 500 cells/μL (Grade 4 neutropenia, per NCI CTCAE). DSN is defined as the interval from the day of first observation of Grade 4 neutropenia to first ANC recovery to ≥ 2,000 cells/μL (Grade 0). Patients who do not present with Grade 4 neutropenia are censored in this analysis.
Outcome Time Frame:
Up to 21 days
Safety Issue:
Yes
Principal Investigator
Thomas Niederman, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
SPI-GCF-12-201
NCT ID:
NCT01724866
Start Date:
January 2013
Completion Date:
December 2014
Related Keywords:
- Neutropenia
- Breast Neoplasms
- Neutropenia
Name | Location |
|---|---|
| North County Oncology | Oceanside, California 92056 |
| Beaver Medical Group | Highland, California 92346 |
| Arizona Center for Cancer Care | Glendale, Arizona 85306 |
| California Cancer Associates for Research and Excellence | Fresno, California 93720 |
| Desert Springs Cancer Care | Scottdale, Arizona 85255 |
| Hematology Oncology Medical Group | Orange, California 92868 |
| Thomas Niederman, M.D., Ph.D | Boynton Beach, Florida 33426 |
| Good Samaritan Hospital, Corvallis | Corvallis, Oregon 97330 |
