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

Sponsor

Xiamen Amoytop Biotech Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT02005458

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

6.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer Breast Cancer	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	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Dec 1, 2013

Actual Primary Completion Date :

Mar 1, 2017

Actual Study Completion Date :

Feb 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhangzhou Municipal Hospital of Fujian Province	Zhangzhou	Fujian	China	363000
2	Shaaxi Provincial Tumor Hospital	Xi'an	Shaanxi	China	710061
3	Cancer Institute and Hospital, CAMS	Beijing		China
4	Fujian cancer hospital	Fuzhou		China
5	Fujian Medical University Union Hospital	Fuzhou		China
6	Fuzhou General Hospital of Nanjing Military Command	Fuzhou		China
7	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou		China
8	Shanghai Changzheng Hospital	Shanghai		China
9	Shanghai Chest Hospital	Shanghai		China
10	Tongji Hospital, Tongji Medical College Huazhou University of Science & Technology	Wuhan		China
11	The First Affiliated Hospital of Xiamen University	Xiamen		China
12	Zhejiang cancer hospital	Zhejiang		China