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Study of the Efficacy and Safety of Empegfilgrastim for Neutropenia Prophylaxis in Breast Cancer Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biocad
ClinicalTrials.gov Identifier:
NCT02104830
First received: April 2, 2014
Last updated: August 31, 2016
Last verified: August 2016
Results First Received: February 5, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Supportive Care
Condition: Chemotherapy-induced Neutropenia
Interventions: Biological: Empegfilrastim 6 mg
Biological: Filgrastim
Biological: Placebo №1
Biological: Placebo №2
Biological: Empegfilrastim 7.5 mg

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
7 patients were withdrawn for various reasons without receiving any dose of any of the studied products.

Reporting Groups
  Description
Empegfilgrastim 6 mg

Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy

Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.

Empegfilgrastim 7.5 mg

Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy

Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.

Filgrastim

Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy

Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0.


Participant Flow:   Overall Study
    Empegfilgrastim 6 mg   Empegfilgrastim 7.5 mg   Filgrastim
STARTED   42   43   43 
COMPLETED   38   36   36 
NOT COMPLETED   4   7   7 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Empegfilgrastim 6 mg

Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy and placebo #2 in a dose of 0.0083 ml/kg in 24-27 hour after chemotherapy, then patient received placebo #2 in dose 0.0083 ml/kg until ANC ≥ 10x109/L or during 14 days

empegfilrastim 6 mg: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 6 mg.

Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.

Empegfilgrastim 7.5 mg

Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy and placebo #2 in a dose of 0.0083 ml/kg in 24-27 hour after chemotherapy, then patient received placebo #2 in dose 0.0083 ml/kg until ANC ≥ 10x109/L or during 14 days

Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.

empegfilrastim 7.5 mg: Empegfilgrastim is supplied as solution for injection 3 mg/ml.

Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 6 mg.

Filgrastim

Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy and placebo #1 in dose 1.0 ml ubcutaneously, 24 h after the chemotherapy.

filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir.

Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0.

Total Total of all reporting groups

Baseline Measures
   Empegfilgrastim 6 mg   Empegfilgrastim 7.5 mg   Filgrastim   Total 
Overall Participants Analyzed 
[Units: Participants]
 42   43   43   128 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   42   43   43   128 
>=65 years   0   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.38  (11.07)   50.42  (9.19)   51.86  (9.68)   50.23  (10.03) 
Gender 
[Units: Participants]
       
Female   42   43   43   128 
Male   0   0   0   0 
Region of Enrollment 
[Units: Participants]
       
Russian Federation   42   43   43   128 
Histologic type 
[Units: Participants]
       
Infiltrative ductal   27   28   33   88 
Infiltrative lobular   6   3   2   11 
Medullar   0   1   0   1 
Squamous cell cancer   0   1   0   1 
Infiltrative not specified   4   5   4   13 
Low-grade differentiated carcinoma   2   3   1   6 
Undifferentiated cancer   3   2   3   8 
Disease stage 
[Units: Participants]
       
IIA   13   12   10   35 
IIB   5   7   9   21 
IIIA   5   7   10   22 
IIIB   12   10   8   30 
IIIС   2   1   0   3 
IV   5   6   6   17 
History previous therapy of breast cancer [1] 
[Units: Participants]
       
Adjuvant chemotherapy   7   8   10   25 
Neoadjuvant chemotherapy   1   1   0   2 
Radiotherapy   8   4   3   15 
Hormone therapy   6   7   4   17 
Surgery treatment   28   27   22   77 
Any treatment   28   29   26   83 
[1] Patients with previous therapy could be treated with several different types of therapy (for example surgery treatment and adjuvant chemotherapy)
Duration of a disease 
[Units: Months]
Mean (Full Range)
 16.14 
 (1.0 to 144.0) 
 11.62 
 (1.0 to 144.0) 
 5.37 
 (1.0 to 51.0) 
 11.0 
 (1.0 to 144.0) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Duration of Neutropenia CTCAE Grade 4   [ Time Frame: 3 weeks ]

2.  Secondary:   The Duration of Grade 4 Neutropenia From the 2nd (Week 6) to 4th Cycle (Week 12);   [ Time Frame: 2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12) ]

3.  Secondary:   The Incidence of Severe Neutropenia (Grade 3-4)   [ Time Frame: 16 weeks ]

4.  Secondary:   Low Level (Nadir) ANC x 10^9/L   [ Time Frame: 1st cycle (week 3), 2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12) ]

5.  Secondary:   Neutropenia Duration, Any Grade   [ Time Frame: 1st cycle (week 3), 2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12) ]

6.  Secondary:   Duration From ANC Nadir to ANC < 2.0 x 10^9/L   [ Time Frame: 1st cycle (week 3), 2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Roman Ivanov, Director of Clinical Trials
Organization: Biocad
phone: +7 (812) 380 49 33 ext 950
e-mail: ivanov@biocad.ru



Responsible Party: Biocad
ClinicalTrials.gov Identifier: NCT02104830     History of Changes
Other Study ID Numbers: BCD-017-3
Study First Received: April 2, 2014
Results First Received: February 5, 2015
Last Updated: August 31, 2016