Clinical Trial: Phase 2 Study of HM10460A or Pegfilgrastim Use for the Management of Neutropenia in Breast Cancer Patients
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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 a
Brief 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.
Detailed Summary:
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.
Sponsor: Spectrum Pharmaceuticals, Inc
Current Primary Outcome: Duration of severe neutropenia (DSN) in Cycle 1 [ Time Frame: Up to 21 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Effect of Test Doses of HM10460A [ Time Frame: Up to 84 days ]To determine the effect of test doses of HM10460A on the DSN in Cycles 2-4.
- Effect of Test Doses of HM10460A [ Time Frame: Up to 84 days ]To determine the effect of test doses of HM10460A on the absolute neutrophil count (ANC) in Cycles 1-4.
- Effect of Test Doses of HM10460A [ Time Frame: Up to 84 days ]To determine the effect of test doses of HM10460A on the febrile neutropenia (FN) rates by cycle and overall across Cycles 1-4.
- Effect of Test Doses of HM10460A [ Time Frame: Up to 84 days ]To determine the effect of test doses of HM10460A on the number/duration of hospitalizations.
- Effect of Test Doses of HM10460A [ Time Frame: Up to 84 days ]
To determine the effect of test doses of HM10460A on the:
• Immunogenicity : The immunogenicity blood sample will be collected to test for antibodies binding to HM10460A and native G-CSF on Day -1 of each cycle (prior to administration of corticosteroids) and at the End of Study Visit.
Original Secondary Outcome: Same as current
Information By: Spectrum Pharmaceuticals, Inc
Dates:
Date Received: October 24, 2012
Date Started: January 2013
Date Completion:
Last Updated: May 26, 2015
Last Verified: May 2015