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

This study is currently recruiting participants.
Verified April 2014 by Spectrum Pharmaceuticals, Inc
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01724866
First received: October 24, 2012
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Neutropenia
Drug: HM10460A (45 μg/kg)
Drug: HM10460A (135 μg/kg)
Drug: HM10460A (270 μg/kg)
Drug: Pegfilgrastim 6mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 and Neoadjuvant Chemotherapy With the Docetaxel + Cyclophosphamide (TC) Regimen

Resource links provided by NLM:


Further study details as provided by Spectrum Pharmaceuticals, Inc:

Primary Outcome Measures:
  • Duration of severe neutropenia (DSN) in Cycle 1 [ Time Frame: Up to 21 days ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Effect of Test Doses of HM10460A [ Time Frame: Up to 84 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

    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.



Estimated Enrollment: 144
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single-dose HM10460A (45 μg/kg)
Single-dose HM10460A (45 μg/kg) should be administered on Day 2 of each cycle, approximately 24 hours (±2 hours) after TC chemotherapy.
Drug: HM10460A (45 μg/kg)
Single-dose subcutaneous injection
Experimental: Single-dose HM10460A (135 μg/kg)
Single-dose HM10460A (135 μg/kg) should be administered on Day 2 of each cycle, approximately 24 hours (±2 hours) after TC chemotherapy.
Drug: HM10460A (135 μg/kg)
Single-dose subcutaneous injection
Experimental: Single-dose HM10460A (270 μg/kg)
Single-dose HM10460A (270 μg/kg) should be administered on Day 2 of each cycle, approximately 24 hours (±2 hours) after TC chemotherapy.
Drug: HM10460A (270 μg/kg)
Single-dose subcutaneous injection
Active Comparator: Pegfilgrastim 6 mg
Pegfilgrastim (Neulasta®) is not to be administered between 14 days before or 24 hours after TC chemotherapy. Pegfilgrastim (Neulasta®) will be administered according to the manufacturer's Prescribing Information (6 mg subcutaneously once per chemotherapy cycle).
Drug: Pegfilgrastim 6mg
Single-dose subcutaneous injection, per manufacturer's Prescribing Information
Other Name: Neulasta®

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01724866

Contacts
Contact: Dennis Kim, MD, MPH (949) 743-9229 Dennis.Kim@sppirx.com

  Show 53 Study Locations
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc
Investigators
Principal Investigator: Thomas Niederman, MD University Cancer Institute
Principal Investigator: Emad Ibrahim, MD Beaver Medical Group
Principal Investigator: Andrew J Buresh, MD Desert Springs Cancer Care
Principal Investigator: Timothy E Byun, MD Hematology Oncology Medical Group
Principal Investigator: Clarence S Adoo, MD Arizona Center for Cancer Care
Principal Investigator: Steven J Hager, DO California Cancer Associates for Research and Excellence
Principal Investigator: Warren S Paroly, MD North County Oncology
Principal Investigator: Michael A Kosmo, MD California Cancer Associates for Research and Excellence
Principal Investigator: Kimberly McGregor Good Samaritan Hospital, Corvallis
  More Information

No publications provided

Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01724866     History of Changes
Other Study ID Numbers: SPI-GCF-12-201
Study First Received: October 24, 2012
Last Updated: April 15, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neutropenia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014