Study of Recombinant Human Serum Albumin/Granulocyte Colony-Stimulating Factor Fusion Protein

• Status: Completed
• Trial end date: 2016-04-26
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tianjin SinoBiotech Ltd.
• Treatments: Lenograstim

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