Safety and Efficacy of YPEG-rhG-CSF in Cancer Patients Receiving Chemotherapy

Multi-center, Randomized, Open-labeled, Positive-controlled, Phase Ⅱ Study to Evaluate Efficacy and Safety of YPEG-rhG-CSF, Once-per-cycle, Comparing to PEG-rhG-CSF, Once-per-cycle, in Chemotherapy-induced Neutropenia of Patients With Malignancies Receiving Myelosuppressive Chemotherapy.

This study is to examine which dose of YPEG-rhG-CSF, once-per-cycle, has similar efficacy and safety, comparing to PEG-rhG-CSF, once-per-cycle, in chemotherapy-induced neutropenia

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Non Small Cell Lung Cancer
• Intervention / Treatment: Drug: YPEG-rhG-CSF, 20μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle; Drug: YPEG-rhG-CSF, 30μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle; Drug: YPEG-rhG-CSF, 45μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle; Drug: PEG-rhG-CSF, 100μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Cancer Institute and Hospital, CAMS
  • Fuzhou, China
    • Fujian Medical University Union Hospital
  • Fuzhou, China
    • Fujian Cancer Hospital
  • Fuzhou, China
    • Fuzhou General hospital of Nanjing Military Command
  • Guangzhou, China
    • The First Affiliated Hospital of Guangzhou Medical University
  • Shanghai, China
    • Shanghai Chest Hospital
  • Shanghai, China
    • Shanghai Changzheng Hospital
  • Wuhan, China
    • Tongji Hospital, Tongji Medical College Huazhou University of Science & Technology
  • Xiamen, China
    • The First Affiliated Hospital of Xiamen University
  • Zhejiang, China
    • Zhejiang Cancer Hospital
  • Fujian
    • Zhangzhou, Fujian, China, 363000
      • Zhangzhou Municipal Hospital of Fujian Province
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • Shaaxi Provincial Tumor Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of non-small cell lung cancer or Breast cancer, and adequate for carboplatin combined with taxol or cyclophosphamide combined with pharmorubicin chemotherapy
• Karnofsky Score ≥ 70
• Life Expectancy > 3 months
• Age: 18～70yrs.
• Peripheral blood test: WBC≥3.5×106/mm3, PLT≥100×106/mm3, ANC≥1.5×106/mm3; Normal bone marrow function; Bone marrow biopsy shows active hematopoietic without cancer cells.
• Normal coagulation function, no evidences of hemorrhage tendency.
• No exiting diseases or condition that may influence drug absorption, distribution, metabolism, and excretion.
• Adequate liver, cardiac, kidney function. Indicators of liver function test ≤ 2.5ULN, Indicators of kidney function test ≤ 1ULN
• Understand and voluntarily sign an informed consent form.

Exclusion Criteria:

• Pregnant or lactating females
• Evidence of tumor metastasis in bone marrow
• Lack insight due to tumor metastasis in the central nervous system
• Prior bone marrow transplant or stem cell transplant
• Infective symptom before enrollment into this study
• Other malignancy history
• Known hypersensitivity to any component of the drug(e.g. rh-G-CSF) that to be administered
• Subject enrolled in any other investigational drug or device trial within 3 months of informed consent date
• Drug abuser or alcoholist
• Prior radiotherapy or expected to received radiotherapy
• Unstable or uncontrolled cardiac or hypertension
• Other conditions which in the opinion of the investigator preclude enrollment into the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: YPEG-rhG-CSF 20μg/kg; 20μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle	Drug: YPEG-rhG-CSF, 20μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle
Experimental: YPEG-rhG-CSF 30μg/kg; 30μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle	Drug: YPEG-rhG-CSF, 30μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle
Experimental: YPEG-rhG-CSF 45μg/kg; 45μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle	Drug: YPEG-rhG-CSF, 45μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle
Active Comparator: PEG-rhG-CSF 100μg/kg; 100μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle	Drug: PEG-rhG-CSF, 100μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Grade 3 &4 neutropenia, and median duration of neutropenia in the two experimental cycles	Grade 3 and 4 neutropenia means absolute neutrophil count is less than 1000/mm3 and 500/mm3 , respectively	21 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of febrile neutropenia in the two experimental cycles	Febrile neutropenia means absolute neutrophil count is less than 500/mm3 or absolute neutrophil count between 500/mm3 and 1000mm3 but probably to decline to less than 500mm3 within 48hrs, and body temperature is higher than 38.5 degrees celsius or higher than 38.0 degrees celsius and lasting for more than 1hr	21 day
Diversification of neutrophil in the two experimental cycles		21 day

Collaborators and Investigators

• Sponsor: Xiamen Amoytop Biotech Co., Ltd.
• Investigators: Principal Investigator: Yuankai Shi, Ph.D, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2013
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: December 3, 2013
• First Submitted That Met QC Criteria: December 6, 2013
• First Posted (Estimate): December 9, 2013

Study Record Updates

• Last Update Posted (Actual): July 17, 2018
• Last Update Submitted That Met QC Criteria: July 15, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Neutropenia; Febrile neutropenia; PEG-rhG-CSF; Myelosuppressive chemotherapy
• Additional Relevant MeSH Terms: Hematologic Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Neutropenia
• Other Study ID Numbers: TB1309CSF