Trial record 1 of 1 for:    NCT01724866
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Phase 2 Study of HM10460A or Pegfilgrastim Use for the Management of Neutropenia in Breast Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01724866
First received: October 24, 2012
Last updated: June 10, 2014
Last verified: June 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01724866

  Show 49 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: June 10, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neutropenia
Breast Neoplasms
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Immunoglobulin Fc Fragments
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014