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

NCT02005458 | Completed Phase 2

• 1 other identifier: TB1309CSF
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 12

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

Keywords

Neutropenia; Febrile neutropenia; PEG-rhG-CSF; Myelosuppressive chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence of febrile neutropenia in the two experimental cycles

  21 day

• Diversification of neutrophil in the two experimental cycles

  21 day

Study Arms (4)

YPEG-rhG-CSF 20μg/kg

EXPERIMENTAL

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

YPEG-rhG-CSF 30μg/kg

EXPERIMENTAL

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

YPEG-rhG-CSF 45μg/kg

EXPERIMENTAL

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

PEG-rhG-CSF 100μg/kg

ACTIVE COMPARATOR

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

Interventions

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

YPEG-rhG-CSF 20μg/kg

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

YPEG-rhG-CSF 30μg/kg

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

YPEG-rhG-CSF 45μg/kg

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

PEG-rhG-CSF 100μg/kg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Xiamen Amoytop Biotech Co., Ltd.: lead

Study Sites (12)

Zhangzhou Municipal Hospital of Fujian Province

Zhangzhou, Fujian, 363000, China

Location

Shaaxi Provincial Tumor Hospital

Xi'an, Shaanxi, 710061, China

Location

Cancer Institute and Hospital, CAMS

Beijing, China

Location

Fujian cancer hospital

Fuzhou, China

Location

Fujian Medical University Union Hospital

Fuzhou, China

Location

Fuzhou General Hospital of Nanjing Military Command

Fuzhou, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Location

Shanghai Changzheng Hospital

Shanghai, China

Location

Shanghai Chest Hospital

Shanghai, China

Location

Tongji Hospital, Tongji Medical College Huazhou University of Science & Technology

Wuhan, China

Location

The First Affiliated Hospital of Xiamen University

Xiamen, China

Location

Zhejiang cancer hospital

Zhejiang, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Breast Neoplasms; Neutropenia; Febrile Neutropenia

Interventions

pegylated granulocyte colony-stimulating factor

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Officials

• Yuankai Shi, Ph.D

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2013
• First Posted: December 9, 2013
• Study Start: December 1, 2013
• Primary Completion: March 1, 2017
• Study Completion: February 1, 2018
• Last Updated: July 17, 2018

Record last verified: 2018-02

Locations

CN (12)