Clinical trial NCT02005458: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Breast Cancer
Keywords: Neutropenia
Febrile neutropenia
PEG-rhG-CSF
Myelosuppressive chemotherapy
Lead sponsor: Xiamen Amoytop Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-12-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Incidence of Grade 3 &4 neutropenia, and median duration of neutropenia in the two experimental cycles
timeFrame: 21 day
Secondary outcomes:
measure: Incidence of febrile neutropenia in the two experimental cycles
timeFrame: 21 day
measure: Diversification of neutrophil in the two experimental cycles
timeFrame: 21 day
Other outcomes:
Locations:
city: Zhangzhou
country: China
facility: Zhangzhou Municipal Hospital of Fujian Province
state: Fujian
city: Xi'an
country: China
facility: Shaaxi Provincial Tumor Hospital
state: Shaanxi
city: Beijing
country: China
facility: Cancer Institute and Hospital, CAMS
city: Fuzhou
country: China
facility: Fujian cancer hospital
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
city: Fuzhou
country: China
facility: Fuzhou General Hospital of Nanjing Military Command
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
city: Shanghai
country: China
facility: Shanghai Chest Hospital
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College Huazhou University of Science & Technology
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
city: Zhejiang
country: China
facility: Zhejiang cancer hospital
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Yuankai Shi, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: