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

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ClinicalTrials.gov Identifier: NCT03376503
Recruitment Status : Completed
First Posted : December 18, 2017
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Pegfilgrastim Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : May 25, 2016
Primary Completion Date : October 9, 2017
Study Completion Date : November 6, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Pegcyte (Nanogen pegfilgrastim)
pegcyte 6 mg in the first cycle
Drug: Pegfilgrastim
PK,PD and safety assessment
Active Comparator: Neulastim (Roche pegfilgrastim)
Neulastim 6 mg in the first cycle
Drug: Pegfilgrastim
PK,PD and safety assessment


Outcome Measures

Primary Outcome Measures :
  1. Area under the curve from time 0 to the last time point (AUC0-t) 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 ]
    (AUC0-t)


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. Maximum change in CD34+ count [ Time Frame: day 2 (0h), day 5 (72h), day 7 (120h), and day 8 (144h) of the first cycle. ]
  8. 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 ]
  9. 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 ]
  10. 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 ]
  11. 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 ]
  12. Incidence of adverse events [ Time Frame: cycle 1 from day 2 to day 14 ]
    Including changes in vitals and laboratory investigations


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (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.
Contacts and Locations

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): NCT03376503


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

Responsible Party: Nanogen Pharmaceutical Biotechnology Joint Stock Company
ClinicalTrials.gov Identifier: NCT03376503     History of Changes
Other Study ID Numbers: NNG04
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: December 19, 2017
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
Product Manufactured in and Exported from the U.S.: No

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