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Phase 2 Study of SPI-2012 or Pegfilgrastim for the Management of Neutropenia in Participants With Breast Cancer

Primary Purpose

Neutropenia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SPI-2012
Pegfilgrastim
Docetaxel
Cyclophosphamide
Sponsored by
Spectrum Pharmaceuticals, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neutropenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically confirmed breast cancer and candidate for adjuvant or neoadjuvant chemotherapy
  • Candidate for docetaxel and cyclophosphamide chemotherapy
  • Female or male at least 18 years of age
  • Eastern Cooperative Oncology Group (ECOG) ≤ 2
  • Absolute neutrophil count (ANC) ≥ 1.5×109/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).
  • Aspartate aminotransferase per serum glutamic-oxaloacetic transaminase (AST/SGOT) and/or alanine aminotransferase per serum glutamic-pyruvic transaminase (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
  • Known Human Immunodeficiency Virus (HIV) infection
  • Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) diagnosis with detectable viral load or immunological evidence of chronic active disease
  • Active infection or any serious underlying medical condition that would impair ability to receive protocol treatment
  • Prior bone marrow or stem cell transplant
  • Prolonged exposure to glucocorticosteroids and immunosuppressive agents

Sites / Locations

  • Arizona Center for Cancer Care
  • Desert Springs Cancer Care
  • California Cancer Associates for Research and Excellence
  • Beaver Medical Group
  • California Cancer Associates for Research and Excellence
  • Innovative Clinical Research Institute
  • Kentucky Cancer Clinic
  • New York Oncology Hematology, PC
  • North Shore Hematology/Oncology Associates
  • Good Samaritan Hospital, Corvallis
  • Frankston Hospital
  • Royal Hobart
  • Ashford Cancer Center Research
  • Breast Cancer Research Center, WA
  • Ballarat Oncology & Haematology
  • LTD " Cancer Center of Adjara Autonomic Republic"
  • Ltd ' Medulla - Chemotherapy and Immunotherapy Clinic
  • State Health Center
  • National Institute of Oncology
  • Uzsoki Hospital
  • University Debrecen, Oncology Clinic
  • Szabolcs - Szatmár - Bereg megyei Kórházak és Egyetemi Oktatókórház
  • Ziv Medical Center
  • Regionalny Szpital Specjalistyczny
  • Szpital Uniwersytecki w Krakowie
  • Dzienny Oddział Chemioterapii
  • MTZ Clinical Research Sp. z o.o.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm 1: SPI-2012 45 µg/kg and Docetaxel + Cyclophosphamide (TC)

Arm 2: SPI-2012 135 µg/kg and Docetaxel + Cyclophosphamide (TC)

Arm 3: SPI-2012 270 µg/kg and Docetaxel + Cyclophosphamide (TC)

Arm 4: Pegfilgrastim and Docetaxel + Cyclophosphamide (TC)

Arm Description

Participants received SPI-2012 45 microgram/kilogram (µg/kg), subcutaneously (SC) once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 milligram/ square metre (mg/m^2) intravenous (IV) infusion over 60 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes.

Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m^2 intravenous (IV) infusion over 60 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes.

Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m^2 intravenous (IV) infusion over 60 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes.

Participants received Pegfilgrastim 6 milligram (mg), SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m^2 intravenous (IV) infusion over 60 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes.

Outcomes

Primary Outcome Measures

Duration of Severe Neutropenia (DSN) in Cycle 1
DSN was defined as the interval from the day of first observation of severe neutropenia (ANC <0.5*10^9/L, Grade 4 neutropenia per NCI CTCAE) to the first ANC recovery to => 2.0*10^9/L in Cycle 1.

Secondary Outcome Measures

Duration of DSN in Cycle 2
DSN was defined as the interval from the day of first observation of severe neutropenia (ANC <0.5*10^9/L, Grade 4 neutropenia per NCI CTCAE) to the first ANC recovery to => 2.0*10^9/L in Cycle 2.
Duration of DSN in Cycle 3
DSN was defined as the interval from the day of first observation of severe neutropenia (ANC <0.5*10^9/L, Grade 4 neutropenia per NCI CTCAE) to the first ANC recovery to => 2.0*10^9/L in Cycle 3.
Duration of DSN in Cycle 4
DSN was defined as the interval from the day of first observation of severe neutropenia (ANC <0.5*10^9/L, Grade 4 neutropenia per NCI CTCAE) to the first ANC recovery to => 2.0*10^9/L in Cycle 4.
Time to ANC Recovery in Cycle 1
Time to ANC recovery was defined as the time from chemotherapy administration until ANC increased to ≥ 2×10^9/L after the expected nadir within Cycle 1. Time to ANC recovery was not calculated for participants whose ANC value didn't drop below 2 x10^9/L within Cycle 1.
Time to ANC Recovery in Cycle 2
Time to ANC recovery was defined as the time from chemotherapy administration until ANC increased to ≥2×10^9/L after the expected nadir within Cycle 2. Time to ANC recovery was not calculated for participants whose ANC value didn't drop below 2 x10^9/L within Cycle 2.
Time to ANC Recovery in Cycle 3
Time to ANC recovery was defined as the time from chemotherapy administration until ANC increased to ≥2×10^9/L after the expected nadir within Cycle 3. Time to ANC recovery was not calculated for participants whose ANC value didn't drop below 2 x10^9/L within Cycle 3.
Time to ANC Recovery in Cycle 4
Time to ANC recovery was defined as the time from chemotherapy administration until ANC increased to ≥2×10^9/L after the expected nadir within Cycle 4. Time to ANC recovery was not calculated for participants whose ANC value didn't drop below 2 x10^9/L within Cycle 4.
Absolute Neutrophil Count (ANC) Nadir Overtime in Cycle 1
Mean ANC nadir was defined as the mean of the lowest ANC value (*10^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 1.
Absolute ANC Nadir Overtime in Cycle 2
Mean ANC nadir was defined as the mean of the lowest ANC value (*10^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 2.
Absolute ANC Nadir Overtime in Cycle 3
Mean ANC nadir was defined as the mean of the lowest ANC value (*10^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 3.
Absolute ANC Nadir Overtime in Cycle 4
Mean ANC nadir was defined as the mean of the lowest ANC value (*10^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 4.
Depth of ANC Nadir in Cycle 1
Depth of ANC nadir was defined as the lowest Median ANC value (*10^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 1.
Depth of ANC Nadir in Cycle 2
Depth of ANC nadir was defined as the lowest Median ANC value (*10^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 2.
Depth of ANC Nadir in Cycle 3
Depth of ANC nadir was defined as the lowest Median ANC value (*10^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 3.
Depth of ANC Nadir in Cycle 4
Depth of ANC nadir was defined as the lowest Median ANC value (*10^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 4.
Time to ANC Nadir in Cycle 1
Time to ANC nadir was defined as the time from chemotherapy administration until the occurrence of the ANC nadir.
Time to ANC Nadir in Cycle 2
Time to ANC nadir was defined as the time from chemotherapy administration until the occurrence of the ANC nadir.
Time to ANC Nadir in Cycle 3
Time to ANC nadir was defined as the time from chemotherapy administration until the occurrence of the ANC nadir.
Time to ANC Nadir in Cycle 4
Time to ANC nadir was defined as the time from chemotherapy administration until the occurrence of the ANC nadir.
Percentage of Participants With Febrile Neutropenia (FN) Across All Cycles From Cycle 1 to Cycle 4
FN was defined as a temperature of more than 38.2 degree Celsius (°C) concurrent with an ANC greater than 0.5×10^9/L..
Number of Participants With Worst Grade Adverse Events (AEs), Deaths, Other Serious Adverse Events (SAEs), and Other AEs Leading to Discontinuation From Study Therapy, and Worst Grade Laboratory Abnormalities
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Participants with SAE other than death were reported.AE and Laboratory Abnormalities ("Hematology and Chemistry") were collected and graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03, where Grade 3 refers to severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated and Grade 4 refers to life-threatening consequences; urgent intervention indicated.
Percentage of Participants With Hospitalization Across All Cycles From Cycle 1 to Cycle 4
Number of Participants With Positive Antibodies for SPI-2012
Serum samples were to be tested in a screening assay for antibodies binding to SPI-2012 using a validated enzyme-linked immunosorbent assay (ELISA). Any serum samples positive for the antibody were to be tested in a confirmatory competitive inhibition assay using two antigens, SPI-2012 or granulocyte colony-stimulating factor (G-CSF), to confirm the presence of antibodies binding to SPI-2012 and to identify samples that were positive for antibodies binding to G-CSF.
Time to Reach Maximum Concentration of SPI-2012 (Tmax)
Blood samples were collected at specific time points to determine the serum concentrations of SPI-2012 and to derive pharmacokinetic (PK) parameters.
Maximum Concentration of SPI-2012 (Cmax)
Blood samples were collected at specific time points to determine the serum concentrations of SPI-2012 and to derive PK parameters.
Area Under the Serum Concentration-Time Curve From Time Zero to 312 Hours Post-Dose (AUC0-312)
AUC(0-312) is the area under the serum concentration-time curve from time zero to 312 hour post dose calculated by the linear trapezoidal rule. Blood samples were collected at specific time points to determine the serum concentrations of SPI-2012 and to derive PK parameters.
Half-life of SPI-2012 (t1/2)
t1/2 data were calculated and reported as harmonic mean and pseudo standard deviation (SD). Blood samples were collected at specific time points to determine the serum concentrations of SPI-2012 and to derive PK parameters.

Full Information

First Posted
October 24, 2012
Last Updated
March 22, 2022
Sponsor
Spectrum Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01724866
Brief Title
Phase 2 Study of SPI-2012 or Pegfilgrastim for the Management of Neutropenia in Participants With Breast Cancer
Official Title
Phase 2, Open-Label, Dose-Ranging Study of SPI-2012 (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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 25, 2013 (Actual)
Primary Completion Date
August 12, 2014 (Actual)
Study Completion Date
August 12, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spectrum Pharmaceuticals, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the effect of test doses of SPI-2012 on the duration of severe neutropenia (DSN) during Cycle 1 in participants with breast cancer who are candidates for adjuvant or neoadjuvant chemotherapy.
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 SPI-2012 relative to a fixed dose of pegfilgrastim as a concurrent active control to each dose of SPI-2012 in participants with breast cancer. This study included four arms comprising three dose levels of SPI-2012 (Arm 1: 45 µg/kg, Arm 2: 135 µg/kg, Arm 3: 270 µg/kg) versus pegfilgrastim (Arm 4: 6 mg). The start of study is defined as the initiation of treatment with SPI-2012 or pegfilgrastim. The duration of treatment consists of a maximum of 4 cycles (21 days per cycle) beginning on Day 1 with chemotherapy administration and continue through Day 21, plus a 30-day follow-up period, unless any of the discontinuation criteria applies. The target population are participants with breast cancer who are candidates for neoadjuvant or adjuvant treatment with Docetaxel + Cyclophosphamide (TC) chemotherapy. All participants who receive at least 1 dose of either SPI-2012 or pegfilgrastim were followed for safety through 30 days after their last dose of study treatment or until all treatment-related adverse events (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neutropenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: SPI-2012 45 µg/kg and Docetaxel + Cyclophosphamide (TC)
Arm Type
Experimental
Arm Description
Participants received SPI-2012 45 microgram/kilogram (µg/kg), subcutaneously (SC) once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 milligram/ square metre (mg/m^2) intravenous (IV) infusion over 60 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes.
Arm Title
Arm 2: SPI-2012 135 µg/kg and Docetaxel + Cyclophosphamide (TC)
Arm Type
Experimental
Arm Description
Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m^2 intravenous (IV) infusion over 60 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes.
Arm Title
Arm 3: SPI-2012 270 µg/kg and Docetaxel + Cyclophosphamide (TC)
Arm Type
Experimental
Arm Description
Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m^2 intravenous (IV) infusion over 60 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes.
Arm Title
Arm 4: Pegfilgrastim and Docetaxel + Cyclophosphamide (TC)
Arm Type
Experimental
Arm Description
Participants received Pegfilgrastim 6 milligram (mg), SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m^2 intravenous (IV) infusion over 60 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes.
Intervention Type
Drug
Intervention Name(s)
SPI-2012
Other Intervention Name(s)
Rolontis®, HM10460A, Eflapegrastim
Intervention Description
SPI-2012 SC injection.
Intervention Type
Drug
Intervention Name(s)
Pegfilgrastim
Other Intervention Name(s)
Neulasta®
Intervention Description
Pegfilgrastim SC injection, per manufacturer's Prescribing Information.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
Docetaxel given based on standard dose for chemotherapy.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
Cytoxan
Intervention Description
Cyclophosphamide given based on standard dose for chemotherapy.
Primary Outcome Measure Information:
Title
Duration of Severe Neutropenia (DSN) in Cycle 1
Description
DSN was defined as the interval from the day of first observation of severe neutropenia (ANC <0.5*10^9/L, Grade 4 neutropenia per NCI CTCAE) to the first ANC recovery to => 2.0*10^9/L in Cycle 1.
Time Frame
Cycle 1 (each cycle was 21 days)
Secondary Outcome Measure Information:
Title
Duration of DSN in Cycle 2
Description
DSN was defined as the interval from the day of first observation of severe neutropenia (ANC <0.5*10^9/L, Grade 4 neutropenia per NCI CTCAE) to the first ANC recovery to => 2.0*10^9/L in Cycle 2.
Time Frame
Cycle 2 (each cycle was 21 days)
Title
Duration of DSN in Cycle 3
Description
DSN was defined as the interval from the day of first observation of severe neutropenia (ANC <0.5*10^9/L, Grade 4 neutropenia per NCI CTCAE) to the first ANC recovery to => 2.0*10^9/L in Cycle 3.
Time Frame
Cycle 3 (each cycle was 21 days)
Title
Duration of DSN in Cycle 4
Description
DSN was defined as the interval from the day of first observation of severe neutropenia (ANC <0.5*10^9/L, Grade 4 neutropenia per NCI CTCAE) to the first ANC recovery to => 2.0*10^9/L in Cycle 4.
Time Frame
Cycle 4 (each cycle was 21 days)
Title
Time to ANC Recovery in Cycle 1
Description
Time to ANC recovery was defined as the time from chemotherapy administration until ANC increased to ≥ 2×10^9/L after the expected nadir within Cycle 1. Time to ANC recovery was not calculated for participants whose ANC value didn't drop below 2 x10^9/L within Cycle 1.
Time Frame
Cycle 1 (each cycle was 21 days)
Title
Time to ANC Recovery in Cycle 2
Description
Time to ANC recovery was defined as the time from chemotherapy administration until ANC increased to ≥2×10^9/L after the expected nadir within Cycle 2. Time to ANC recovery was not calculated for participants whose ANC value didn't drop below 2 x10^9/L within Cycle 2.
Time Frame
Cycle 2 (each cycle was 21 days)
Title
Time to ANC Recovery in Cycle 3
Description
Time to ANC recovery was defined as the time from chemotherapy administration until ANC increased to ≥2×10^9/L after the expected nadir within Cycle 3. Time to ANC recovery was not calculated for participants whose ANC value didn't drop below 2 x10^9/L within Cycle 3.
Time Frame
Cycle 3 (each cycle was 21 days)
Title
Time to ANC Recovery in Cycle 4
Description
Time to ANC recovery was defined as the time from chemotherapy administration until ANC increased to ≥2×10^9/L after the expected nadir within Cycle 4. Time to ANC recovery was not calculated for participants whose ANC value didn't drop below 2 x10^9/L within Cycle 4.
Time Frame
Cycle 4 (each cycle was 21 days)
Title
Absolute Neutrophil Count (ANC) Nadir Overtime in Cycle 1
Description
Mean ANC nadir was defined as the mean of the lowest ANC value (*10^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 1.
Time Frame
Cycle 1 (each cycle was 21 days)
Title
Absolute ANC Nadir Overtime in Cycle 2
Description
Mean ANC nadir was defined as the mean of the lowest ANC value (*10^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 2.
Time Frame
Cycle 2 (each cycle was 21 days)
Title
Absolute ANC Nadir Overtime in Cycle 3
Description
Mean ANC nadir was defined as the mean of the lowest ANC value (*10^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 3.
Time Frame
Cycle 3 (each cycle was 21 days)
Title
Absolute ANC Nadir Overtime in Cycle 4
Description
Mean ANC nadir was defined as the mean of the lowest ANC value (*10^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 4.
Time Frame
Cycle 4 (each cycle was 21 days)
Title
Depth of ANC Nadir in Cycle 1
Description
Depth of ANC nadir was defined as the lowest Median ANC value (*10^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 1.
Time Frame
Cycle 1 (each cycle was 21 days)
Title
Depth of ANC Nadir in Cycle 2
Description
Depth of ANC nadir was defined as the lowest Median ANC value (*10^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 2.
Time Frame
Cycle 2 (each cycle was 21 days)
Title
Depth of ANC Nadir in Cycle 3
Description
Depth of ANC nadir was defined as the lowest Median ANC value (*10^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 3.
Time Frame
Cycle 3 (each cycle was 21 days)
Title
Depth of ANC Nadir in Cycle 4
Description
Depth of ANC nadir was defined as the lowest Median ANC value (*10^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 4.
Time Frame
Cycle 4 (each cycle was 21 days)
Title
Time to ANC Nadir in Cycle 1
Description
Time to ANC nadir was defined as the time from chemotherapy administration until the occurrence of the ANC nadir.
Time Frame
Cycle 1 (each cycle was 21 days)
Title
Time to ANC Nadir in Cycle 2
Description
Time to ANC nadir was defined as the time from chemotherapy administration until the occurrence of the ANC nadir.
Time Frame
Cycle 2 (each cycle was 21 days)
Title
Time to ANC Nadir in Cycle 3
Description
Time to ANC nadir was defined as the time from chemotherapy administration until the occurrence of the ANC nadir.
Time Frame
Cycle 3 (each cycle was 21 days)
Title
Time to ANC Nadir in Cycle 4
Description
Time to ANC nadir was defined as the time from chemotherapy administration until the occurrence of the ANC nadir.
Time Frame
Cycle 4 (each cycle was 21 days)
Title
Percentage of Participants With Febrile Neutropenia (FN) Across All Cycles From Cycle 1 to Cycle 4
Description
FN was defined as a temperature of more than 38.2 degree Celsius (°C) concurrent with an ANC greater than 0.5×10^9/L..
Time Frame
Cycle 1 to Cycle 4 (each cycle was 21 days)
Title
Number of Participants With Worst Grade Adverse Events (AEs), Deaths, Other Serious Adverse Events (SAEs), and Other AEs Leading to Discontinuation From Study Therapy, and Worst Grade Laboratory Abnormalities
Description
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Participants with SAE other than death were reported.AE and Laboratory Abnormalities ("Hematology and Chemistry") were collected and graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03, where Grade 3 refers to severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated and Grade 4 refers to life-threatening consequences; urgent intervention indicated.
Time Frame
From the first dose up to 30 days post last dose of study drug (up to 4 months)
Title
Percentage of Participants With Hospitalization Across All Cycles From Cycle 1 to Cycle 4
Time Frame
All cycles from Cycle 1 to Cycle 4 (each cycle was 21 days)
Title
Number of Participants With Positive Antibodies for SPI-2012
Description
Serum samples were to be tested in a screening assay for antibodies binding to SPI-2012 using a validated enzyme-linked immunosorbent assay (ELISA). Any serum samples positive for the antibody were to be tested in a confirmatory competitive inhibition assay using two antigens, SPI-2012 or granulocyte colony-stimulating factor (G-CSF), to confirm the presence of antibodies binding to SPI-2012 and to identify samples that were positive for antibodies binding to G-CSF.
Time Frame
Up to the end of the study (Approximately 3.5 months)
Title
Time to Reach Maximum Concentration of SPI-2012 (Tmax)
Description
Blood samples were collected at specific time points to determine the serum concentrations of SPI-2012 and to derive pharmacokinetic (PK) parameters.
Time Frame
Pre-dose and at 1, 3, 6, 8, 10, 24, 48, 72, 144, 192, and 312 hours post-dose in Cycle 1 (each cycle was 21 days)
Title
Maximum Concentration of SPI-2012 (Cmax)
Description
Blood samples were collected at specific time points to determine the serum concentrations of SPI-2012 and to derive PK parameters.
Time Frame
Pre-dose and at 1, 3, 6, 8, 10, 24, 48, 72, 144, 192, and 312 hours post-dose in Cycle 1 (each cycle was 21 days)
Title
Area Under the Serum Concentration-Time Curve From Time Zero to 312 Hours Post-Dose (AUC0-312)
Description
AUC(0-312) is the area under the serum concentration-time curve from time zero to 312 hour post dose calculated by the linear trapezoidal rule. Blood samples were collected at specific time points to determine the serum concentrations of SPI-2012 and to derive PK parameters.
Time Frame
Pre-dose and at 1, 3, 6, 8, 10, 24, 48, 72, 144, 192, and 312 hours post-dose in Cycle 1 (each cycle was 21 days)
Title
Half-life of SPI-2012 (t1/2)
Description
t1/2 data were calculated and reported as harmonic mean and pseudo standard deviation (SD). Blood samples were collected at specific time points to determine the serum concentrations of SPI-2012 and to derive PK parameters.
Time Frame
Pre-dose and at 1, 3, 6, 8, 10, 24, 48, 72, 144, 192, and 312 hours post-dose in Cycle 1 (each cycle was 21 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed breast cancer and candidate for adjuvant or neoadjuvant chemotherapy Candidate for docetaxel and cyclophosphamide chemotherapy Female or male at least 18 years of age Eastern Cooperative Oncology Group (ECOG) ≤ 2 Absolute neutrophil count (ANC) ≥ 1.5×109/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). Aspartate aminotransferase per serum glutamic-oxaloacetic transaminase (AST/SGOT) and/or alanine aminotransferase per serum glutamic-pyruvic transaminase (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 Known Human Immunodeficiency Virus (HIV) infection Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) diagnosis with detectable viral load or immunological evidence of chronic active disease Active infection or any serious underlying medical condition that would impair ability to receive protocol treatment Prior bone marrow or stem cell transplant Prolonged exposure to glucocorticosteroids and immunosuppressive agents
Facility Information:
Facility Name
Arizona Center for Cancer Care
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Desert Springs Cancer Care
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85255
Country
United States
Facility Name
California Cancer Associates for Research and Excellence
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Beaver Medical Group
City
Highland
State/Province
California
ZIP/Postal Code
92346
Country
United States
Facility Name
California Cancer Associates for Research and Excellence
City
Los Angeles
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Innovative Clinical Research Institute
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Kentucky Cancer Clinic
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41701
Country
United States
Facility Name
New York Oncology Hematology, PC
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
North Shore Hematology/Oncology Associates
City
Setauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States
Facility Name
Good Samaritan Hospital, Corvallis
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330
Country
United States
Facility Name
Frankston Hospital
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Royal Hobart
City
Brisbane
ZIP/Postal Code
7000
Country
Australia
Facility Name
Ashford Cancer Center Research
City
Kurralta Park
ZIP/Postal Code
5037
Country
Australia
Facility Name
Breast Cancer Research Center, WA
City
Perth
ZIP/Postal Code
6000
Country
Australia
Facility Name
Ballarat Oncology & Haematology
City
Wendouree
ZIP/Postal Code
3355
Country
Australia
Facility Name
LTD " Cancer Center of Adjara Autonomic Republic"
City
Batumi
ZIP/Postal Code
6000
Country
Georgia
Facility Name
Ltd ' Medulla - Chemotherapy and Immunotherapy Clinic
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Facility Name
State Health Center
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
National Institute of Oncology
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Uzsoki Hospital
City
Budapest
ZIP/Postal Code
1146
Country
Hungary
Facility Name
University Debrecen, Oncology Clinic
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Szabolcs - Szatmár - Bereg megyei Kórházak és Egyetemi Oktatókórház
City
Nyíregyháza
Country
Hungary
Facility Name
Ziv Medical Center
City
Zefat
ZIP/Postal Code
13100
Country
Israel
Facility Name
Regionalny Szpital Specjalistyczny
City
Grudziądz
ZIP/Postal Code
86-300
Country
Poland
Facility Name
Szpital Uniwersytecki w Krakowie
City
Kraków
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Dzienny Oddział Chemioterapii
City
Racibórz
ZIP/Postal Code
47-400
Country
Poland
Facility Name
MTZ Clinical Research Sp. z o.o.
City
Warszawa
ZIP/Postal Code
02-106
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29573207
Citation
Vacirca JL, Chan A, Mezei K, Adoo CS, Papai Z, McGregor K, Okera M, Horvath Z, Landherr L, Hanslik J, Hager SJ, Ibrahim EN, Rostom M, Bhat G, Choi MR, Reddy G, Tedesco KL, Agajanian R, Lang I, Schwartzberg LS. An open-label, dose-ranging study of Rolontis, a novel long-acting myeloid growth factor, in breast cancer. Cancer Med. 2018 May;7(5):1660-1669. doi: 10.1002/cam4.1388. Epub 2018 Mar 23.
Results Reference
derived

Learn more about this trial

Phase 2 Study of SPI-2012 or Pegfilgrastim for the Management of Neutropenia in Participants With Breast Cancer

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