Clinical trial NCT02465801: Study of Recombinant Human Serum Albumin/Granulocyte Colony-Stimulating Factor Fusion Protein
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chemotherapy-induced Neutropenia
Lead sponsor: Tianjin SinoBiotech Ltd.
Sponsor class: INDUSTRY
First posted: 2015-06-08
Enrollment: 216
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: The mean of duration for class IV neutrophilic granulocytopenia
timeFrame: 4 weeks
Secondary outcomes:
measure: The mean of duration for class IV neutrophilic granulocytopenia
timeFrame: 8 weeks
measure: The mean of duration for ANC up to 2.0×109/L
timeFrame: 8 weeks
measure: ANC
timeFrame: 8 weeks
measure: The usage of antibiotics
timeFrame: 8 weeks
measure: febrile neutropenia
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Scienses
Study officials:
affiliation: CAMS
name: Binhe Xu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen S, Han Y, Ouyang Q, Lu J, Zhang Q, Yang S, Wang J, Huang H, Liu H, Shao Z, Li H, Chen Z, Sun S, Geng C, Lu J, Sun J, Wang J, Xu B. Randomized and dose-escalation trials of recombinant human serum albumin /granulocyte colony-stimulating factor in patients with breast cancer receiving anthracycline-containing chemotherapy. BMC Cancer. 2021 Mar 31;21(1):341. doi: 10.1186/s12885-021-08093-z.