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

NCT03376503 | Completed Phase 1 DMC

• 1 other identifier: NNG04
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Pegcyte (Nanogen pegfilgrastim)

EXPERIMENTAL

pegcyte 6 mg in the first cycle

Drug: Pegfilgrastim

Neulastim (Roche pegfilgrastim)

ACTIVE COMPARATOR

Neulastim 6 mg in the first cycle

Drug: Pegfilgrastim

Interventions

Pegfilgrastim DRUG

PK,PD and safety assessment

Neulastim (Roche pegfilgrastim); Pegcyte (Nanogen pegfilgrastim)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanogen Pharmaceutical Biotechnology Joint Stock Company: lead

Study Sites (1)

Vietnam National Cancer Institute (Hospital K)

Hanoi, Vietnam

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pegfilgrastim

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: December 18, 2017
• Study Start: May 25, 2016
• Primary Completion: October 9, 2017
• Study Completion: November 6, 2017
• Last Updated: December 19, 2017

Record last verified: 2017-12

Locations

VN (1)