- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03381417
Nanogen Pegcyte Clinical Study for the Prevention of CIN in Breast-cancer Patients.
December 28, 2017 updated by: Nanogen Pharmaceutical Biotechnology Joint Stock Company
A Randomized, Double-blind, Parallel Study Comparing Efficacy and Safety of Pegcyte (Nanogen) and Reference Product Neulastim (Roche) for Prevention of Chemotherapy (Accelerated AC Regimen)Induced Neutropenia in Breast-cancer Patients.
Accelerated AC regimen-Doxorubicin 60 mg/m2,Cyclophosphamide 600 mg/m2 on day 1 & day 14 of each cycle along with G-CSF support for up to 4 cycles, followed by Paclitaxel 175 mg/m2 in the next 4 cycles is the standard clinical practice in Vietnam for breast cancer, this regimen is to facilitate the dose-dense schedule, patients receive every-2-week therapy along with G-CSF support.
the accelerated dose-dense schedule improve disease-free and overall survival among women with breast cancer .Primary objective of this study is to compare the efficacy and safety of Nanogen's Pegcyte and Roche's Neulastim for prevention of chemotherapy (Accelerated AC regimen)-induced neutropenia on breast cancer patients.
Breast cancer patients scheduled to receive myelosuppressive chemotherapy (AC regimen) will be recruited in this trial.
All eligible patients receive single subcutaneous injection of study drugs 24 hours after chemotherapy administration in each cycle for 3 consecutive cycles.
Efficacy and safety assessments will be assessed based on the incidence of severe neutropenia in combination of temperature > 38.3℃ or sepsis or life threatening infection and incidence of serious adverse events.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
128
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Hanoi, Vietnam
- Vietnam National Cancer Institute (Hospital K)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female patients aged between 18 - 65 years.
- Patients with histological confirmed primary invasive breast cancer; stage I, II or III.
- Patients had no prior chemotherapy treatments.
- Patients scheduled to undergo myelosuppressive Doxorubicin and Cyclophosphamide chemotherapy for 04 cycles, and Paclitaxel chemotherapy for the next 04 cycles; patients were available for 14 days of each cycle for the first 03 chemotherapy cycles.
- Patients with baseline ANC ≥ 1.5 x 109/L, PLT ≥ 100 x 109/L, HgB ≥ 9 g/dL, WBC ≥ 3,000/mL and albumin ≥ 3.0 g/dL.
- Performance status as per ECOG (Eastern Cooperative Oncology Group) score 0, 1 or 2.
- Willing to give written and signed informed consent.
Exclusion Criteria:
- Patients with prior exposure of G-CSF or GM-CSF or its pegylated products in clinical development less than 6 months prior to randomization.
- Myelotoxic concomitant treatment such as chloramphenicol, methotrexate, immunomodulating agents, interferons during 10 days before randomization.
- Received systemic antibiotic treatment within 72 hours of chemotherapy.
- Chronic use of corticosteroids, prior bone marrow or stem cell transplant.
- Patients who had an immediate/ concurrent exposure to radiotherapy or surgery (within 4 weeks).
- Severe medical disease: cardiovascular, hepatic, renal, pulmonary…
- Known cases of hematological disease (sickle cell anemia, AML…)
- History of HIV positive, active hepatitis.
- Pregnant and lactating women or patients planning to become pregnant.
- Known allergic reactions to study medications.
- Positive to anti-pegfilgrastim antibody test
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pegcyte (Nanogen pegfilgrastim)
6 mg in each cycle
|
Eligible patients are scheduled to receive three cycles of chemotherapy every two weeks.
During each chemotherapy cycle pegfilgrastim is injected s.c.
post chemotherapy application.
Other Names:
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Active Comparator: Neulastim (Roche pegfilgrastim)
6 mg in each cycle
|
Eligible patients are scheduled to receive three cycles of chemotherapy every two weeks.
During each chemotherapy cycle pegfilgrastim is injected s.c.
post chemotherapy application.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of patients who developed Febrile neutropenia in cycle 1,2 and 3
Time Frame: 0 to 42 days)
|
0 to 42 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of grade 4 severe neutropenia
Time Frame: in cycle 1,2 and 3 (0 to 14 , 28 and 42 days)
|
in cycle 1,2 and 3 (0 to 14 , 28 and 42 days)
|
|
Incidence of antibiotics use
Time Frame: in cycle 1,2 and 3 (0 to 14 , 28 and 42 days)
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in cycle 1,2 and 3 (0 to 14 , 28 and 42 days)
|
|
Incidence of adverse events
Time Frame: in cycle 1,2 and 3 (0 to 14 , 28 and 42 days)
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in cycle 1,2 and 3 (0 to 14 , 28 and 42 days)
|
|
Changes in laboratory safety parameters
Time Frame: in cycle 1,2 and 3 (0 to 14 , 28 and 42 days)
|
including vital signs
|
in cycle 1,2 and 3 (0 to 14 , 28 and 42 days)
|
Presence of antibodies against Pegfilgrastim
Time Frame: at the end of cycle 3 (42 day)
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at the end of cycle 3 (42 day)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 6, 2016
Primary Completion (Actual)
November 6, 2017
Study Completion (Actual)
November 6, 2017
Study Registration Dates
First Submitted
December 11, 2017
First Submitted That Met QC Criteria
December 17, 2017
First Posted (Actual)
December 22, 2017
Study Record Updates
Last Update Posted (Actual)
January 2, 2018
Last Update Submitted That Met QC Criteria
December 28, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NNG05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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