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Nanogen Pegcyte Clinical Study for the Prevention of CIN in Breast-cancer Patients.

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ClinicalTrials.gov Identifier: NCT03381417
Recruitment Status : Completed
First Posted : December 22, 2017
Last Update Posted : January 2, 2018
Sponsor:
Information provided by (Responsible Party):
Nanogen Pharmaceutical Biotechnology Joint Stock Company

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Female Drug: pegcyte Drug: Neulastim Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 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.
Actual Study Start Date : October 6, 2016
Actual Primary Completion Date : November 6, 2017
Actual Study Completion Date : November 6, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Pegcyte (Nanogen pegfilgrastim)
6 mg in each cycle
Drug: pegcyte
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 Name: pegfilgrastim

Active Comparator: Neulastim (Roche pegfilgrastim)
6 mg in each cycle
Drug: Neulastim
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 Name: pegfilgrastim




Primary Outcome Measures :
  1. Percentage of patients who developed Febrile neutropenia in cycle 1,2 and 3 [ Time Frame: 0 to 42 days) ]

Secondary Outcome Measures :
  1. Incidence of grade 4 severe neutropenia [ Time Frame: in cycle 1,2 and 3 (0 to 14 , 28 and 42 days) ]
  2. Incidence of antibiotics use [ Time Frame: in cycle 1,2 and 3 (0 to 14 , 28 and 42 days) ]
  3. Incidence of adverse events [ Time Frame: in cycle 1,2 and 3 (0 to 14 , 28 and 42 days) ]
  4. Changes in laboratory safety parameters [ Time Frame: in cycle 1,2 and 3 (0 to 14 , 28 and 42 days) ]
    including vital signs

  5. Presence of antibodies against Pegfilgrastim [ Time Frame: at the end of cycle 3 (42 day) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   breast cancer
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03381417


Locations
Vietnam
Vietnam National Cancer Institute (Hospital K)
Hanoi, Vietnam
Sponsors and Collaborators
Nanogen Pharmaceutical Biotechnology Joint Stock Company

Responsible Party: Nanogen Pharmaceutical Biotechnology Joint Stock Company
ClinicalTrials.gov Identifier: NCT03381417     History of Changes
Other Study ID Numbers: NNG05
First Posted: December 22, 2017    Key Record Dates
Last Update Posted: January 2, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases