Phase III Trial Comparing Filgrastim (AryaTinaGene) to Neupogen (Amgen) in the Prevention of Neutropenic Complications in Breast Cancer Patients in Pange-Azar hospital of Gorgan
This randomized, double-blind, phase III trial compared Tinagrast (AraTinaGene) and Neupogen (Inovator by Amgen) for the prevention of neutropenic complications in patients with breast cancer receiving chemotherapy. Patients with breast cancer are randomized into two parallel groups (n=50 per each groups) and receive 5 micrograms per kg body weight of either filgrastim-ATG or neupogen subcutaneously (s.c.) daily. Following administration of chemotherapic agents in day1 of 21-days cycles, patients receive filgrastim beginning on day 2 until day 7. Absolute neutrophil counts and other parameters are determined in both groups
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013062613776N1
Registration date:2013-07-05, 1392/04/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-07-05, 1392/04/14
Registrant information
Name
Hossein Amini
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 1442 1651
Email address
hamini@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arya Tina Gene Biopharm Co
Expected recruitment start date
2013-07-01, 1392/04/10
Expected recruitment end date
2013-11-01, 1392/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Phase III Trial Comparing Filgrastim (AryaTinaGene) to Neupogen (Amgen) in the Prevention of Neutropenic Complications in Breast Cancer Patients in Pange-Azar hospital of Gorgan
Public title
Clinical efficacy of Filgrastim-AryaTinaGene
Purpose
Other
Inclusion/Exclusion criteria
The study population consisted of women ≥ 18 years of age
with metastatic or localized histopathologically proven
breast cancer. Patients with localized cancer were required
to have ≥ stage II disease with ≥ 1 positive regional node.
Additional inclusion criteria included: Karnofsky performance
status ≥ 70% for patients ≤ 70 years of age and ≥ 90%
for patients > 70 years of age; adequate hematologic function
(absolute neutrophil count [ANC] ≥3000 cells/μL,
platelet count >100,000/μL, hemoglobin [Hb] ≥ 8 g/dL); adequate
hepatic function (bilirubin ≤ 1.5 × upper limit of normal
[ULN], aspartate aminotransferase and alanine aminotransferase
≤ 2.5 × ULN, alkaline phosphatase ≤ 5 × ULN);
creatinine ≤ 2.0 × ULN; and normal cardiac function as determined
by MUGA (multiple-gated acquisition) scan or
echocardiography. All hematologic, renal, and hepatic valueshad to be within institutional normal limits in patients > 70
years of age. All women who had received prior chemotherapy
must have completed treatment at least 3 weeks prior to
study drug administration, and women of child-bearing age
had to agree to comply with effective contraception and have
done so since their last menses. Patients who had received
radiotherapy within 4 weeks of entry required special permission
from the study sponsors to enroll.
Patients were excluded if they had received a cumulative
lifetime dose of doxorubicin > 240 mg/m2 or epirubicin > 432
mg/m2, prior treatment with mitomycin-C or busulfan, or >
2 prior regimens of chemotherapy (excluding hormonal
treatment). Additional exclusion criteria included a history
of significant cardiac disease, arrhythmias, uncontrolled hypertension,
recent myocardial infarction, or ischemia. Patients
with human immunodeficiency virus infection, active
hepatitis, or a history of a serious comorbid condition, uncontrolled
metabolic disease, or psychiatric condition that
would impair tolerance or evaluation of the study drug were
also excluded.
Age
From 18 years old to 90 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Golestan University of Medical Sciences
Street address
Gorgan, Shast cola road, Falsafi Building
City
Gorgan
Postal code
Approval date
2013-06-25, 1392/04/04
Ethics committee reference number
77392032906
Health conditions studied
1
Description of health condition studied
Neutropenia
ICD-10 code
D70
ICD-10 code description
Primary outcomes
1
Description
Days of severe neuropenia (ANC>200 per ul)
Timepoint
Every chemotherapy cycle
Method of measurement
Absolute neutrophil count (per ul of blood)
2
Description
Days of minor neuropenia (ANC>500-1000 per ul)
Timepoint
Every chemotherapy cycle
Method of measurement
Absolute neutrophil count (per ul of blood)
3
Description
Days of moderate neuropenia (ANC>200-500 per ul)
Timepoint
Every chemotherapy cycle
Method of measurement
Absolute neutrophil count (per ul of blood)
Secondary outcomes
1
Description
Occurance of febrile neutropenia
Timepoint
every chemotherapy cycle
Method of measurement
Fever of 38.5 C for at least 1 h and neutropenia less than 500 per ul
2
Description
Occurance of sepsis related to filgrastim
Timepoint
every chemotherapy cycle
Method of measurement
Blood analysis
3
Description
Occurance of increased hepatic enzymes related to filgrastim
Timepoint
every chemotherapy cycle
Method of measurement
Blood analysis
4
Description
Occurance of musculoskeletal pain related to filgrastim
Timepoint
every chemotherapy cycle
Method of measurement
Patient questionery
Intervention groups
1
Description
Invention was granlocyte-colony stimulating factor as recombinant product made by AryaTinaGene Biopharm Co namely Filgrastim-ATG for group A and Neupogen (Amgen) for group B as standard treatment. Administration of filgrastim 1 day after chemotherapy at least for 5 days and maximum for 14 days at a dose of 5 ug/kg/day and comparison of clinical outcomes
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pange-Azar hospital of Gorgan
Full name of responsible person
Dr. Seyyed Reza Khandoozi
Street address
Gorgan ValiAsr Sq. Chemotherapy Center
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
AryaTinaGene Biopharm Co.
Full name of responsible person
Dr. Majid Shahbazi
Street address
Gorgan, Aghghala Industrial Zone, Sazandegi2
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
AryaTinaGene Biopharm Co.
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Golestan University of Medical sciences
Full name of responsible person
Hossein Amini
Position
Assistant Prof of Pharmacology dept, Ph.D
Other areas of specialty/work
Street address
Gorgan, Shast cola Road, Falsafi Buldings
City
Gorgan
Postal code
Phone
+98 17 1552 5972
Fax
+98 17 1552 5972
Email
hamini@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Abasali Keshtkar
Position
Assistant professor of Epidemiology
Other areas of specialty/work
Street address
Tehran, Shariati Hospital Osteoprosis research Center
City
Tehran
Postal code
Phone
+98 912 717 9137
Fax
Email
abkeshtkar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ronakdarou Biopharm Co.
Full name of responsible person
Dr. Zahra Kororian
Position
MD
Other areas of specialty/work
Street address
Tehran Fatemi Sq. Ardashir St.
City
Tehran
Postal code
Phone
+98 21 8897 9428
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)