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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02005458
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Xiamen Amoytop Biotech Co., Ltd.

Tracking Information
First Submitted Date  ICMJE December 3, 2013
First Posted Date  ICMJE December 9, 2013
Last Update Posted Date July 17, 2018
Actual Study Start Date  ICMJE December 2013
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2013)
Incidence of Grade 3 &4 neutropenia, and median duration of neutropenia in the two experimental cycles [ Time Frame: 21 day ]
Grade 3 and 4 neutropenia means absolute neutrophil count is less than 1000/mm3 and 500/mm3 , respectively
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2013)
  • Incidence of febrile neutropenia in the two experimental cycles [ Time Frame: 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 [ Time Frame: 21 day ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of YPEG-rhG-CSF in Cancer Patients Receiving Chemotherapy
Official Title  ICMJE 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.
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Non Small Cell Lung Cancer
  • Breast Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: YPEG-rhG-CSF 20μg/kg
    20μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle
    Intervention: 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
    Intervention: 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
    Intervention: 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
    Intervention: Drug: PEG-rhG-CSF, 100μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 6, 2013)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2018
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02005458
Other Study ID Numbers  ICMJE TB1309CSF
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xiamen Amoytop Biotech Co., Ltd.
Study Sponsor  ICMJE Xiamen Amoytop Biotech Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yuankai Shi, Ph.D Cancer Institute and Hospital, Chinese Academy of Medical Sciences
PRS Account Xiamen Amoytop Biotech Co., Ltd.
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP