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Nanogen Pegfilgrastim (Pegcyte) PK/PD Clinical Study in Breast Cancer Patients

Primary Purpose

Breast Cancer

Status

Completed

Phase

Phase 1

Locations

Vietnam

Study Type

Interventional

Intervention

Pegfilgrastim

About this trial

This is an interventional prevention trial for Breast Cancer

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

pegcyte 6 mg in the first cycle

Neulastim 6 mg in the first cycle

Outcomes

Primary Outcome Measures

Area under the curve from time 0 to the last time point (AUC0-t) for serum Pegfilgrastim (PEG-GCSF)

(AUC0-t)

Secondary Outcome Measures

Apparent clearance (CL) for serum Pegfilgrastim

Maximum concentration (Cmax) for serum Pegfilgrastim

Half-life (T½) for serum Pegfilgrastim (PEG-GCSF)

Area under the serum concentration-time curve (AUC0-inf) of Pegfilgrastim

Time to maximum concentration (Tmax) for serum Pegfilgrastim

Terminal elimination rate constant (λz) for serum Pegfilgrastim

Maximum change in CD34+ count

Area under the curve above baseline of ANC [ANC_AUC(0-tlast)]

Time of maximum change from baseline for ANC in days (ANC_Tmax)

Maximum change from baseline in absolute neutrophil count from time 0 to the last time point ANC AUC0-t

Maximum change from baseline in absolute neutrophil count (ANC); ANC_Cmax

Incidence of adverse events

Including changes in vitals and laboratory investigations

Full Information

NCT ID

NCT03376503

First Posted

December 12, 2017

Last Updated

December 17, 2017

Sponsor

Nanogen Pharmaceutical Biotechnology Joint Stock Company

1. Study Identification

Unique Protocol Identification Number

NCT03376503

Brief Title

Nanogen Pegfilgrastim (Pegcyte) PK/PD Clinical Study in Breast Cancer Patients

Official Title

A Randomized, Double-blind, Parallel Study Comparing Pharmacokinetic (PK) and Pharmacodynamic (PD) Parameters of Pegcyte (Nanogen) and Reference Product Neulastim (Roche) for Chemotherapy-induced Neutropenia in Breast-cancer Patients

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Completed

Study Start Date

May 25, 2016 (Actual)

Primary Completion Date

October 9, 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

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Breast cancer patients scheduled to receive myelosuppressive chemotherapy (AC regimen) will be enrolled in this study. Eligible patients receive single SC injection of pegcyte or neulastim 24 hours after administration of chemotherapy (Doxorubicin and Cyclophosphamide) in the first cycle (14 days each cycle). Blood samples are collected to determine the serum concentration of investigational drugs at specific time points in the first cycle. Absolute neutrophil count, CD34+ count, Cmax (maximum serum concentration), AUC0-t (area under the curve of the plasma concentration time) and Tmax (time required to reach Cmax) will be calculated from the serum concentration profile

6. Conditions and Keywords

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

Breast Cancer

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pegcyte (Nanogen pegfilgrastim)

Arm Type

Experimental

Arm Description

pegcyte 6 mg in the first cycle

Arm Title

Neulastim (Roche pegfilgrastim)

Arm Type

Active Comparator

Arm Description

Neulastim 6 mg in the first cycle

Intervention Type

Drug

Intervention Name(s)

Pegfilgrastim

Intervention Description

PK,PD and safety assessment

Primary Outcome Measure Information:

Title

Area under the curve from time 0 to the last time point (AUC0-t) for serum Pegfilgrastim (PEG-GCSF)

Description

(AUC0-t)

Time Frame

day 2 (0h, 3h, 6h, 12±4h), day 3 (24h), day 4 (48h), day 5 (72h), day 7 (120h), day 8 (144h), day 9 (168h), day 11 (216h), and day 14 (288h) of the first cycle

Secondary Outcome Measure Information:

Title

Apparent clearance (CL) for serum Pegfilgrastim

Time Frame

day 2 (0h, 3h, 6h, 12±4h), day 3 (24h), day 4 (48h), day 5 (72h), day 7 (120h), day 8 (144h), day 9 (168h), day 11 (216h), and day 14 (288h) of the first cycle

Title

Maximum concentration (Cmax) for serum Pegfilgrastim

Time Frame

day 2 (0h, 3h, 6h, 12±4h), day 3 (24h), day 4 (48h), day 5 (72h), day 7 (120h), day 8 (144h), day 9 (168h), day 11 (216h), and day 14 (288h) of the first cycle

Title

Half-life (T½) for serum Pegfilgrastim (PEG-GCSF)

Time Frame

day 2 (0h, 3h, 6h, 12±4h), day 3 (24h), day 4 (48h), day 5 (72h), day 7 (120h), day 8 (144h), day 9 (168h), day 11 (216h), and day 14 (288h) of the first cycle

Title

Area under the serum concentration-time curve (AUC0-inf) of Pegfilgrastim

Time Frame

day 2 (0h, 3h, 6h, 12±4h), day 3 (24h), day 4 (48h), day 5 (72h), day 7 (120h), day 8 (144h), day 9 (168h), day 11 (216h), and day 14 (288h) of the first cycle

Title

Time to maximum concentration (Tmax) for serum Pegfilgrastim

Time Frame

day 2 (0h, 3h, 6h, 12±4h), day 3 (24h), day 4 (48h), day 5 (72h), day 7 (120h), day 8 (144h), day 9 (168h), day 11 (216h), and day 14 (288h) of the first cycle

Title

Terminal elimination rate constant (λz) for serum Pegfilgrastim

Time Frame

day 2 (0h, 3h, 6h, 12±4h), day 3 (24h), day 4 (48h), day 5 (72h), day 7 (120h), day 8 (144h), day 9 (168h), day 11 (216h), and day 14 (288h) of the first cycle

Title

Maximum change in CD34+ count

Time Frame

day 2 (0h), day 5 (72h), day 7 (120h), and day 8 (144h) of the first cycle.

Title

Area under the curve above baseline of ANC [ANC_AUC(0-tlast)]

Time Frame

day 2 (0h, 3h, 6h, 12±4h), day 3 (24h), day 4 (48h), day 5 (72h), day 7 (120h), day 8 (144h), day 9 (168h), day 11 (216h), and day 14 (288h) of the first cycle

Title

Time of maximum change from baseline for ANC in days (ANC_Tmax)

Time Frame

day 2 (0h, 3h, 6h, 12±4h), day 3 (24h), day 4 (48h), day 5 (72h), day 7 (120h), day 8 (144h), day 9 (168h), day 11 (216h), and day 14 (288h) of the first cycle

Title

Maximum change from baseline in absolute neutrophil count from time 0 to the last time point ANC AUC0-t

Time Frame

day 2 (0h, 3h, 6h, 12±4h), day 3 (24h), day 4 (48h), day 5 (72h), day 7 (120h), day 8 (144h), day 9 (168h), day 11 (216h), and day 14 (288h) of the first cycle

Title

Maximum change from baseline in absolute neutrophil count (ANC); ANC_Cmax

Time Frame

day 2 (0h, 3h, 6h, 12±4h), day 3 (24h), day 4 (48h), day 5 (72h), day 7 (120h), day 8 (144h), day 9 (168h), day 11 (216h), and day 14 (288h) of the first cycle

Title

Incidence of adverse events

Description

Including changes in vitals and laboratory investigations

Time Frame

cycle 1 from day 2 to day 14

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 Pegfilgrastim (Pegcyte) PK/PD Clinical Study in Breast Cancer Patients

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