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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Xiamen Amoytop Biotech Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Xiamen Amoytop Biotech Co., Ltd.
ClinicalTrials.gov Identifier:
NCT02005458
First received: December 3, 2013
Last updated: July 10, 2014
Last verified: June 2014
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Xiamen Amoytop Biotech Co., Ltd.:

Primary Outcome Measures:
  • Incidence of Grade 3 &4 neutropenia, and median duration of neutropenia in the two experimental cycles [ Time Frame: 21 day ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 21 day ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 21 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: December 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02005458

Contacts
Contact: Yuankai Shi, Ph.D 8610-87788701

Locations
China
Cancer Institute and Hospital, CAMS Recruiting
Beijing, China
Contact: Wang Runhua, Ph.D    +86-592-6889121    clinical@amoytop.com   
Fujian Medical University Union Hospital Recruiting
Fuzhou, China
Contact: Wang Runhua, Ph.D    +86-0592-6889121    clinical@amoytop.com   
Fujian cancer hospital Recruiting
Fuzhou, China
Contact: Wang Runhua, Ph.D    +86-0592-6889121    clinical@amoytop.com   
Fuzhou General Hospital of Nanjing Military Command Recruiting
Fuzhou, China
Contact: Wang Runhua    +86-0592-6889121    clinical@amoytop.com   
The First Affiliated Hospital of Guangzhou Medical University Recruiting
Guangzhou, China
Contact: Wang Runhua, Ph.D    +86-0592-6889121    clinical@amoytop.com   
Shanghai Changzheng Hospital Recruiting
Shanghai, China
Contact: Wang Runhua, Ph.D    +86-0592-6889121    clinical@amoytop.com   
Shanghai Chest Hospital Recruiting
Shanghai, China
Contact: Wang Runhua, Ph.D    +86-0592-6889121    clinical@amoytop.com   
Tongji Hospital, Tongji Medical College Huazhou University of Science & Technology Recruiting
Wuhan, China
Contact: Wang Runhua, Ph.D    +86-0592-6889121    clinical@amoytop.com   
The First Affiliated Hospital of Xiamen University Recruiting
Xiamen, China
Contact: Wang Runhua    +86-0592-6889121    clinical@amoytop.com   
Zhejiang cancer hospital Recruiting
Zhejiang, China
Contact: Wang Runhua, Ph.D    +86-0592-6889121    Clinical@amoytop.com   
Sponsors and Collaborators
Xiamen Amoytop Biotech Co., Ltd.
Investigators
Principal Investigator: Yuankai Shi, Ph.D Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  More Information

No publications provided

Responsible Party: Xiamen Amoytop Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT02005458     History of Changes
Other Study ID Numbers: TB1309CSF
Study First Received: December 3, 2013
Last Updated: July 10, 2014
Health Authority: China: Food and Drug Administrition

Keywords provided by Xiamen Amoytop Biotech Co., Ltd.:
Neutropenia
Febrile neutropenia
PEG-rhG-CSF
Myelosuppressive chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 24, 2014