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

NCT ID: NCT02005458

Last Updated: 2018-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2018-02-28

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

Conditions

Non Small Cell Lung Cancer; Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

YPEG-rhG-CSF 20μg/kg

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

YPEG-rhG-CSF 30μg/kg

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

YPEG-rhG-CSF 45μg/kg

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

PEG-rhG-CSF 100μg/kg

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiamen Amoytop Biotech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuankai Shi, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

Zhangzhou Municipal Hospital of Fujian Province

Zhangzhou, Fujian, China

Shaaxi Provincial Tumor Hospital

Xi'an, Shaanxi, 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

The First Affiliated Hospital of Xiamen University

Xiamen, , China

Zhejiang cancer hospital

Zhejiang, , China

Countries

China

Other Identifiers

TB1309CSF

Identifier Type: -

Identifier Source: org_study_id