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

Primary Purpose

Non Small Cell Lung Cancer, Breast Cancer

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
YPEG-rhG-CSF, 20μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle
YPEG-rhG-CSF, 30μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle
YPEG-rhG-CSF, 45μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle
PEG-rhG-CSF, 100μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle
Sponsored by
Xiamen Amoytop Biotech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring Neutropenia, Febrile neutropenia, PEG-rhG-CSF, Myelosuppressive chemotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zhangzhou Municipal Hospital of Fujian Province
  • Shaaxi Provincial Tumor Hospital
  • Cancer Institute and Hospital, CAMS
  • Fujian cancer hospital
  • Fujian Medical University Union Hospital
  • Fuzhou General Hospital of Nanjing Military Command
  • The First Affiliated Hospital of Guangzhou Medical University
  • Shanghai Changzheng Hospital
  • Shanghai Chest Hospital
  • Tongji Hospital, Tongji Medical College Huazhou University of Science & Technology
  • The First Affiliated Hospital of Xiamen University
  • Zhejiang cancer hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

YPEG-rhG-CSF 20μg/kg

YPEG-rhG-CSF 30μg/kg

YPEG-rhG-CSF 45μg/kg

PEG-rhG-CSF 100μg/kg

Arm Description

20μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle

30μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle

45μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle

100μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Diversification of neutrophil in the two experimental cycles

Full Information

First Posted
December 3, 2013
Last Updated
July 15, 2018
Sponsor
Xiamen Amoytop Biotech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02005458
Brief Title
Safety and Efficacy of YPEG-rhG-CSF in Cancer Patients Receiving Chemotherapy
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
December 2013 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiamen Amoytop Biotech Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer, Breast Cancer
Keywords
Neutropenia, Febrile neutropenia, PEG-rhG-CSF, Myelosuppressive chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
YPEG-rhG-CSF 20μg/kg
Arm Type
Experimental
Arm Description
20μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle
Arm Title
YPEG-rhG-CSF 30μg/kg
Arm Type
Experimental
Arm Description
30μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle
Arm Title
YPEG-rhG-CSF 45μg/kg
Arm Type
Experimental
Arm Description
45μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle
Arm Title
PEG-rhG-CSF 100μg/kg
Arm Type
Active Comparator
Arm Description
100μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle
Intervention Type
Drug
Intervention Name(s)
YPEG-rhG-CSF, 20μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle
Intervention Type
Drug
Intervention Name(s)
YPEG-rhG-CSF, 30μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle
Intervention Type
Drug
Intervention Name(s)
YPEG-rhG-CSF, 45μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle
Intervention Type
Drug
Intervention Name(s)
PEG-rhG-CSF, 100μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle
Primary Outcome Measure Information:
Title
Incidence of Grade 3 &4 neutropenia, and median duration of neutropenia in the two experimental cycles
Description
Grade 3 and 4 neutropenia means absolute neutrophil count is less than 1000/mm3 and 500/mm3 , respectively
Time Frame
21 day
Secondary Outcome Measure Information:
Title
Incidence of febrile neutropenia in the two experimental cycles
Description
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
Time Frame
21 day
Title
Diversification of neutrophil in the two experimental cycles
Time Frame
21 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuankai Shi, Ph.D
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhangzhou Municipal Hospital of Fujian Province
City
Zhangzhou
State/Province
Fujian
ZIP/Postal Code
363000
Country
China
Facility Name
Shaaxi Provincial Tumor Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Facility Name
Cancer Institute and Hospital, CAMS
City
Beijing
Country
China
Facility Name
Fujian cancer hospital
City
Fuzhou
Country
China
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
Country
China
Facility Name
Fuzhou General Hospital of Nanjing Military Command
City
Fuzhou
Country
China
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
Country
China
Facility Name
Shanghai Changzheng Hospital
City
Shanghai
Country
China
Facility Name
Shanghai Chest Hospital
City
Shanghai
Country
China
Facility Name
Tongji Hospital, Tongji Medical College Huazhou University of Science & Technology
City
Wuhan
Country
China
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
Country
China
Facility Name
Zhejiang cancer hospital
City
Zhejiang
Country
China

12. IPD Sharing Statement

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

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