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Trial record 1 of 1 for:    NCT02465801
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Study of Recombinant Human Serum Albumin/Granulocyte Colony-Stimulating Factor Fusion Protein

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ClinicalTrials.gov Identifier: NCT02465801
Recruitment Status : Completed
First Posted : June 8, 2015
Last Update Posted : July 18, 2017
Sponsor:
Information provided by (Responsible Party):
Tianjin SinoBiotech Ltd.

Brief Summary:

The purpose of this study is to evaluate the dosages of recombinant human serum albumin/granulocyte colony-stimulating factor fusion protein by injection for preventing neutrophilic granulocytopenia among chemotherapy patients.

Conduct Pharmacokinetics (PK) study on recombinant human serum albumin/granulocyte colony-stimulating factor fusion protein with recombinant human granulocyte colony-stimulating factor injection as a control.


Condition or disease Intervention/treatment Phase
Chemotherapy-induced Neutropenia Drug: HSA-GCSF 1.2 mg Drug: HSA-GCSF 1.5 mg Drug: GCSF Phase 2

Detailed Description:
  • Brief Protocol: Treat the patients taking Taxotere+Epirubicin+Cyclophosphamide (TEC) treatment or Taxotere+Epirubicin (TE) treatment chemotherapy with the study medicine or positive control during the period between two chemotherapy treatments.
  • Positive control:recombinant human granulocyte colony-stimulating factor injection.
  • Targeted patients: breast cancer
  • Grouping: Group 1: 1.2 mg recombinant human serum albumin/granulocyte colony-stimulating factor fusion protein with TEC or TE treatment; Group 2: 1.5 mg recombinant human serum albumin/granulocyte colony-stimulating factor fusion protein with TEC or TE treatment; Group 3: positive control with TEC or TE treatment.
  • Number of patients: 216
  • Concomitant medicines will be conducted.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficacy and Safety Phase II Study of Recombinant Human Serum Albumin/Granulocyte Colony-Stimulating Factor Fusion Protein for Injection to Prevent Neutrophilic Granulocytopenia Among Chemotherapy Patients
Actual Study Start Date : December 16, 2014
Actual Primary Completion Date : December 23, 2015
Actual Study Completion Date : April 26, 2016


Arm Intervention/treatment
Experimental: Group 1

Intervention: HSA-GCSF 1.2 mg

Drug: TE or TEC TE: Taxotere+Epirubicin Taxotere (75mg/m2) and Epirubicin (75mg/m2), IV on day 1 of each 21 chemotherapy cycle.

TEC:Taxotere+Epirubicin+Cyclophosphamide Taxotere (75mg/m2),Epirubicin (75mg/m2) and Cyclophosphamide (500mg/m2), IV on day 1 of each 21 chemotherapy cycle.

Recombinant Human Serum Albumin/Granulocyte Colony-Stimulating Factor Fusion Protein(1.2mg)will be injected subcutaneously at night o'clock a.m. in the 3rd and 7th day of per chemotherapy cycle. After the injection, stop administrating if Absolute Neutrophil Count (ANC) in peripheral blood exceeded 1.5×109/L at two contiguous times at least. If not up to standard, investigator should decide whether or not the third administration.

Drug: HSA-GCSF 1.2 mg
Human Serum Albumin GCSF 1.2mg at day 3 and Day 7

Experimental: Group 2

Intervention:HSA-GCSF 1.5 mg

Drug: TE or TEC TE: Taxotere+Epirubicin Taxotere (75mg/m2) and Epirubicin (75mg/m2), IV on day 1 of each 21 chemotherapy cycle.

TEC:Taxotere+Epirubicin+Cyclophosphamide Taxotere (75mg/m2),Epirubicin (75mg/m2) and Cyclophosphamide (500mg/m2), IV on day 1 of each 21 chemotherapy cycle.

Recombinant Human Serum Albumin/Granulocyte Colony-Stimulating Factor Fusion Protein(1.5mg)will be injected subcutaneously at night o'clock a.m. in the 3rd and 7th day of per chemotherapy cycle. After the injection, stop administrating if Absolute Neutrophil Count (ANC) in peripheral blood exceeded 1.5×109/L at two contiguous times at least. If not up to standard, investigator should decide whether or not the third administration.

Intervention: Drug: TE or TEC

Drug: HSA-GCSF 1.5 mg
Human Serum Albumin GCSF 1.5 mg at day 3 and Day 7

Active Comparator: Group 3

Intervention: GCSF

Drug: TE or TEC TE: Taxotere+Epirubicin Taxotere (75mg/m2) and Epirubicin (75mg/m2), IV on day 1 of each 21 chemotherapy cycle.

TEC:Taxotere+Epirubicin+Cyclophosphamide Taxotere (75mg/m2),Epirubicin (75mg/m2) and Cyclophosphamide (500mg/m2), IV on day 1 of each 21 chemotherapy cycle.

Recombinant Human Granulocyte Colony-Stimulating Factor Injection (5μg/kg/day) will be injected subcutaneously at night o'clock a.m. from the 3rd of per chemotherapy cycle. After the injection, stop administrating if Absolute Neutrophil Count (ANC) in peripheral blood exceeded 1.5×109/L at two contiguous times at least. The maximum of usage was continuous 14 days.

Intervention: Drug: TE or TEC

Drug: GCSF
GCSF 5 mcg/kg/day




Primary Outcome Measures :
  1. The mean of duration for class IV neutrophilic granulocytopenia [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. The mean of duration for class IV neutrophilic granulocytopenia [ Time Frame: 8 weeks ]
  2. The mean of duration for ANC up to 2.0×109/L [ Time Frame: 8 weeks ]
  3. ANC [ Time Frame: 8 weeks ]
  4. The usage of antibiotics [ Time Frame: 8 weeks ]
  5. febrile neutropenia [ Time Frame: 8 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-65.
  • Diagnosed breast cancer, suitable for TEC or TE .
  • ECOG performance status 0 or 1.
  • Adjuvant chemotherapy; new adjuvant chemotherapy; newly diagnosed class Ⅳ and prior chemotherapy.
  • ANC≥1.5×10 9/L, PLT≥100×10 9/L. No bone marrow metastasis,blood coagulation function normally, no Hemorrhagic tendency.
  • No obvious abnormal ecg examination.
  • TBIL, ALT, AST≤2.5×ULN (≤5×ULN if presence of hepatic metastases).
  • Cr, BUN≤2.5×ULN.
  • Signed informed consent.

Exclusion Criteria:

  • Chemotherapy within past 4 weeks
  • Uncontrolled inflammatory disease,axillary temperature≥38℃.
  • Merging other malignant tumor
  • Pregnancy or nursing status.
  • Participation in another clinical trial with and investigational product within 3 months prior to study entry.
  • Severe diabetes mellitus, or poor blood sugar controller.
  • Allergic disease or allergic constitution. History of protein allergy.
  • History of drug addiction and alcoholism.
  • Hematopoietic stem cell transplantation or organ transplantation.
  • Chronic disease of severe cardiac, kidney and liver.
  • Other conditions that would be excluded from this study according to doctors'judgment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02465801


Locations
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China
Cancer Hospital, Chinese Academy of Medical Scienses
Beijing, China, 100021
Sponsors and Collaborators
Tianjin SinoBiotech Ltd.
Investigators
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Principal Investigator: Binhe Xu, MD CAMS
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tianjin SinoBiotech Ltd.
ClinicalTrials.gov Identifier: NCT02465801    
Other Study ID Numbers: RG01N-0778
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: July 18, 2017
Last Verified: November 2014
Additional relevant MeSH terms:
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Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs