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

Phase 2

Completed

• Conditions: Breast Cancer; Non Small Cell Lung Cancer
• Interventions: Drug: PEG-rhG-CSF, 100μg/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, 20μg/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

• Registration Number: NCT02005458
• Lead Sponsor: Xiamen Amoytop Biotech Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-03
• Study First Submitted QC: 2013-12-06
• Study First Posted: 2013-12-09
• Primary Completion: 2017-03
• Status Verified: 2018-02
• Study Completion: 2018-02
• Last Update Submitted: 2018-07-15
• Last Update Posted: 2018-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEG-rhG-CSF 100μg/kg	PEG-rhG-CSF, 100μg/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
YPEG-rhG-CSF 30μg/kg	YPEG-rhG-CSF, 30μg/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
YPEG-rhG-CSF 20μg/kg	YPEG-rhG-CSF, 20μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle	20μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle
YPEG-rhG-CSF 45μg/kg	YPEG-rhG-CSF, 45μg/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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidence of febrile neutropenia in the two experimental cycles	21 day	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	21 day

Trial Locations

Locations (12)

Zhangzhou Municipal Hospital of Fujian Province; 🇨🇳 Zhangzhou, Fujian, China

Shanghai Changzheng Hospital; 🇨🇳 Shanghai, China

Shaaxi Provincial Tumor Hospital; 🇨🇳 Xi'an, Shaanxi, China

Cancer Institute and Hospital, CAMS; 🇨🇳 Beijing, 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 Chest Hospital; 🇨🇳 Shanghai, China

Tongji Hospital, Tongji Medical College Huazhou University of Science & Technology; 🇨🇳 Wuhan, China

The First Affiliated Hospital of Xiamen University; 🇨🇳 Xiamen, China

Zhejiang cancer hospital; 🇨🇳 Zhejiang, China

Fujian cancer hospital; 🇨🇳 Fuzhou, China