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

Breast Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02005458
• Other study ID #: TB1309CSF
• Status: Completed
• Phase: Phase 2
• Start date: December 2013
• Est. completion date: February 2018

Study information

• Verified date: February 2018
• Source: Xiamen Amoytop Biotech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2018
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma, Non-Small-Cell Lung
• Neutropenia
• Non Small Cell Lung Cancer

Intervention

Drug:
• 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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Xiamen Amoytop Biotech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Diversification of neutrophil in the two experimental cycles		21 day