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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03376503
• Other study ID #: NNG04
• Status: Completed
• Phase: Phase 1
• First received: December 12, 2017
• Last updated: December 17, 2017
• Start date: May 25, 2016
• Est. completion date: November 6, 2017

Study information

• Verified date: December 2017
• Source: Nanogen Pharmaceutical Biotechnology Joint Stock Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 6, 2017
• Est. primary completion date: October 9, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Pegfilgrastim
PK,PD and safety assessment

Locations

Country	Name	City	State
Vietnam	Vietnam National Cancer Institute (Hospital K)	Hanoi

Sponsors (1)

Lead Sponsor	Collaborator
Nanogen Pharmaceutical Biotechnology Joint Stock Company

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve from time 0 to the last time point (AUC0-t) for serum Pegfilgrastim (PEG-GCSF)	(AUC0-t)	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	Apparent clearance (CL) for serum Pegfilgrastim		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	Maximum concentration (Cmax) for serum Pegfilgrastim		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	Half-life (T½) for serum Pegfilgrastim (PEG-GCSF)		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	Area under the serum concentration-time curve (AUC0-inf) of Pegfilgrastim		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	Time to maximum concentration (Tmax) for serum Pegfilgrastim		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	Terminal elimination rate constant (?z) for serum Pegfilgrastim		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	Maximum change in CD34+ count		day 2 (0h), day 5 (72h), day 7 (120h), and day 8 (144h) of the first cycle.
Secondary	Area under the curve above baseline of ANC [ANC_AUC(0-tlast)]		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	Time of maximum change from baseline for ANC in days (ANC_Tmax)		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	Maximum change from baseline in absolute neutrophil count from time 0 to the last time point ANC AUC0-t		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	Maximum change from baseline in absolute neutrophil count (ANC); ANC_Cmax		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	Incidence of adverse events	Including changes in vitals and laboratory investigations	cycle 1 from day 2 to day 14