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

Primary Purpose

Breast Cancer Female

Status

Completed

Phase

Phase 3

Locations

Vietnam

Study Type

Interventional

Intervention

pegcyte

Neulastim

About this trial

This is an interventional prevention trial for Breast Cancer Female

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Vietnam National Cancer Institute (Hospital K)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pegcyte (Nanogen pegfilgrastim)

Neulastim (Roche pegfilgrastim)

Arm Description

6 mg in each cycle

Outcomes

Primary Outcome Measures

Percentage of patients who developed Febrile neutropenia in cycle 1,2 and 3

Secondary Outcome Measures

Incidence of grade 4 severe neutropenia

Incidence of antibiotics use

Incidence of adverse events

Changes in laboratory safety parameters

including vital signs

Presence of antibodies against Pegfilgrastim

Full Information

NCT ID

NCT03381417

First Posted

December 11, 2017

Last Updated

December 28, 2017

Sponsor

Nanogen Pharmaceutical Biotechnology Joint Stock Company

1. Study Identification

Unique Protocol Identification Number

NCT03381417

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Completed

Study Start Date

October 6, 2016 (Actual)

Primary Completion Date

November 6, 2017 (Actual)

Study Completion Date

November 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nanogen Pharmaceutical Biotechnology Joint Stock Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer Female

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

128 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pegcyte (Nanogen pegfilgrastim)

Arm Type

Experimental

Arm Description

6 mg in each cycle

Arm Title

Neulastim (Roche pegfilgrastim)

Arm Type

Active Comparator

Arm Description

6 mg in each cycle

Intervention Type

Drug

Intervention Name(s)

pegcyte

Other Intervention Name(s)

pegfilgrastim

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Neulastim

Other Intervention Name(s)

pegfilgrastim

Intervention Description

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.

Primary Outcome Measure Information:

Title

Percentage of patients who developed Febrile neutropenia in cycle 1,2 and 3

Time Frame

0 to 42 days)

Secondary Outcome Measure Information:

Title

Incidence of grade 4 severe neutropenia

Time Frame

in cycle 1,2 and 3 (0 to 14 , 28 and 42 days)

Title

Incidence of antibiotics use

Time Frame

in cycle 1,2 and 3 (0 to 14 , 28 and 42 days)

Title

Incidence of adverse events

Time Frame

in cycle 1,2 and 3 (0 to 14 , 28 and 42 days)

Title

Changes in laboratory safety parameters

Description

including vital signs

Time Frame

in cycle 1,2 and 3 (0 to 14 , 28 and 42 days)

Title

Presence of antibodies against Pegfilgrastim

Time Frame

at the end of cycle 3 (42 day)

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

breast cancer

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Vietnam National Cancer Institute (Hospital K)

City

Hanoi

Country

Vietnam

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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