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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01724866
Registration number
NCT01724866
Ethics application status
Date submitted
24/10/2012
Date registered
12/11/2012
Date last updated
15/04/2022
Titles & IDs
Public title
Phase 2 Study of SPI-2012 or Pegfilgrastim for the Management of Neutropenia in Participants With Breast Cancer
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Scientific 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
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Secondary ID [1]
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2013-003094-10
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Secondary ID [2]
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SPI-GCF-12-201
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Neutropenia
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Condition category
Condition code
Blood
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Other blood disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - SPI-2012
Treatment: Drugs - Pegfilgrastim
Treatment: Drugs - Docetaxel
Treatment: Drugs - Cyclophosphamide
Experimental: Arm 1: SPI-2012 45 µg/kg and Docetaxel + Cyclophosphamide (TC) - 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.
Experimental: Arm 2: SPI-2012 135 µg/kg and Docetaxel + Cyclophosphamide (TC) - 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.
Experimental: Arm 3: SPI-2012 270 µg/kg and Docetaxel + Cyclophosphamide (TC) - 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.
Experimental: Arm 4: Pegfilgrastim and Docetaxel + Cyclophosphamide (TC) - 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.
Treatment: Drugs: SPI-2012
SPI-2012 SC injection.
Treatment: Drugs: Pegfilgrastim
Pegfilgrastim SC injection, per manufacturer's Prescribing Information.
Treatment: Drugs: Docetaxel
Docetaxel given based on standard dose for chemotherapy.
Treatment: Drugs: Cyclophosphamide
Cyclophosphamide given based on standard dose for chemotherapy.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Duration of Severe Neutropenia (DSN) in Cycle 1
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Assessment method [1]
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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.
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Timepoint [1]
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Cycle 1 (each cycle was 21 days)
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Secondary outcome [1]
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Duration of DSN in Cycle 2
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Assessment method [1]
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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.
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Timepoint [1]
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Cycle 2 (each cycle was 21 days)
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Secondary outcome [2]
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Duration of DSN in Cycle 3
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Assessment method [2]
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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.
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Timepoint [2]
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Cycle 3 (each cycle was 21 days)
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Secondary outcome [3]
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Duration of DSN in Cycle 4
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Assessment method [3]
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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.
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Timepoint [3]
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Cycle 4 (each cycle was 21 days)
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Secondary outcome [4]
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Time to ANC Recovery in Cycle 1
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Assessment method [4]
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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.
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Timepoint [4]
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Cycle 1 (each cycle was 21 days)
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Secondary outcome [5]
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Time to ANC Recovery in Cycle 2
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Assessment method [5]
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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.
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Timepoint [5]
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Cycle 2 (each cycle was 21 days)
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Secondary outcome [6]
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Time to ANC Recovery in Cycle 3
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Assessment method [6]
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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.
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Timepoint [6]
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Cycle 3 (each cycle was 21 days)
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Secondary outcome [7]
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Time to ANC Recovery in Cycle 4
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Assessment method [7]
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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.
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Timepoint [7]
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Cycle 4 (each cycle was 21 days)
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Secondary outcome [8]
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Absolute Neutrophil Count (ANC) Nadir Overtime in Cycle 1
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Assessment method [8]
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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.
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Timepoint [8]
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Cycle 1 (each cycle was 21 days)
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Secondary outcome [9]
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Absolute ANC Nadir Overtime in Cycle 2
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Assessment method [9]
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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.
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Timepoint [9]
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Cycle 2 (each cycle was 21 days)
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Secondary outcome [10]
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Absolute ANC Nadir Overtime in Cycle 3
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Assessment method [10]
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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.
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Timepoint [10]
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Cycle 3 (each cycle was 21 days)
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Secondary outcome [11]
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Absolute ANC Nadir Overtime in Cycle 4
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Assessment method [11]
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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.
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Timepoint [11]
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Cycle 4 (each cycle was 21 days)
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Secondary outcome [12]
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Depth of ANC Nadir in Cycle 1
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Assessment method [12]
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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.
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Timepoint [12]
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Cycle 1 (each cycle was 21 days)
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Secondary outcome [13]
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Depth of ANC Nadir in Cycle 2
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Assessment method [13]
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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.
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Timepoint [13]
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Cycle 2 (each cycle was 21 days)
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Secondary outcome [14]
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Depth of ANC Nadir in Cycle 3
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Assessment method [14]
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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.
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Timepoint [14]
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Cycle 3 (each cycle was 21 days)
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Secondary outcome [15]
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Depth of ANC Nadir in Cycle 4
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Assessment method [15]
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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.
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Timepoint [15]
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Cycle 4 (each cycle was 21 days)
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Secondary outcome [16]
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Time to ANC Nadir in Cycle 1
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Assessment method [16]
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Time to ANC nadir was defined as the time from chemotherapy administration until the occurrence of the ANC nadir.
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Timepoint [16]
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Cycle 1 (each cycle was 21 days)
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Secondary outcome [17]
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Time to ANC Nadir in Cycle 2
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Assessment method [17]
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Time to ANC nadir was defined as the time from chemotherapy administration until the occurrence of the ANC nadir.
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Timepoint [17]
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Cycle 2 (each cycle was 21 days)
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Secondary outcome [18]
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Time to ANC Nadir in Cycle 3
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Assessment method [18]
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Time to ANC nadir was defined as the time from chemotherapy administration until the occurrence of the ANC nadir.
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Timepoint [18]
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Cycle 3 (each cycle was 21 days)
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Secondary outcome [19]
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Time to ANC Nadir in Cycle 4
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Assessment method [19]
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Time to ANC nadir was defined as the time from chemotherapy administration until the occurrence of the ANC nadir.
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Timepoint [19]
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Cycle 4 (each cycle was 21 days)
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Secondary outcome [20]
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Percentage of Participants With Febrile Neutropenia (FN) Across All Cycles From Cycle 1 to Cycle 4
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Assessment method [20]
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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..
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Timepoint [20]
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Cycle 1 to Cycle 4 (each cycle was 21 days)
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Secondary outcome [21]
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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
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Assessment method [21]
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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.
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Timepoint [21]
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From the first dose up to 30 days post last dose of study drug (up to 4 months)
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Secondary outcome [22]
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Percentage of Participants With Hospitalization Across All Cycles From Cycle 1 to Cycle 4
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Assessment method [22]
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Timepoint [22]
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All cycles from Cycle 1 to Cycle 4 (each cycle was 21 days)
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Secondary outcome [23]
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Number of Participants With Positive Antibodies for SPI-2012
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Assessment method [23]
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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.
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Timepoint [23]
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Up to the end of the study (Approximately 3.5 months)
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Secondary outcome [24]
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Time to Reach Maximum Concentration of SPI-2012 (Tmax)
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Assessment method [24]
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Blood samples were collected at specific time points to determine the serum concentrations of SPI-2012 and to derive pharmacokinetic (PK) parameters.
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Timepoint [24]
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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)
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Secondary outcome [25]
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Maximum Concentration of SPI-2012 (Cmax)
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Assessment method [25]
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Blood samples were collected at specific time points to determine the serum concentrations of SPI-2012 and to derive PK parameters.
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Timepoint [25]
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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)
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Secondary outcome [26]
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Area Under the Serum Concentration-Time Curve From Time Zero to 312 Hours Post-Dose (AUC0-312)
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Assessment method [26]
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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.
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Timepoint [26]
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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)
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Secondary outcome [27]
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Half-life of SPI-2012 (t1/2)
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Assessment method [27]
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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.
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Timepoint [27]
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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)
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
25/03/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
12/08/2014
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Sample size
Target
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Accrual to date
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Final
148
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Frankston Hospital - Frankston
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Recruitment hospital [2]
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Royal Hobart - Brisbane
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Recruitment hospital [3]
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Ashford Cancer Center Research - Kurralta Park
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Recruitment hospital [4]
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Breast Cancer Research Center, WA - Perth
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Recruitment hospital [5]
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Ballarat Oncology & Haematology - Wendouree
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Recruitment postcode(s) [1]
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3199 - Frankston
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Recruitment postcode(s) [2]
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7000 - Brisbane
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Recruitment postcode(s) [3]
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5037 - Kurralta Park
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Recruitment postcode(s) [4]
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6000 - Perth
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Recruitment postcode(s) [5]
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3355 - Wendouree
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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Country [2]
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United States of America
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State/province [2]
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California
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Country [3]
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United States of America
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State/province [3]
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Kentucky
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Country [4]
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United States of America
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State/province [4]
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New York
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Country [5]
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United States of America
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State/province [5]
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Oregon
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Country [6]
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Georgia
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State/province [6]
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Batumi
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Country [7]
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Georgia
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State/province [7]
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Tbilisi
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Country [8]
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Hungary
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State/province [8]
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Budapest
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Country [9]
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Hungary
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State/province [9]
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Debrecen
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Country [10]
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Hungary
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State/province [10]
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Nyíregyháza
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Country [11]
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Israel
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State/province [11]
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Zefat
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Country [12]
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Poland
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State/province [12]
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Grudziadz
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Country [13]
0
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Poland
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State/province [13]
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Kraków
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Country [14]
0
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Poland
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State/province [14]
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Racibórz
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Country [15]
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Poland
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State/province [15]
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Warszawa
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Spectrum Pharmaceuticals, Inc
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01724866
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01724866
Download to PDF