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

Condition(s) targeted: Chemotherapy-induced Neutropenia

Intervention: HSA-GCSF 1.2 mg (Drug); HSA-GCSF 1.5 mg (Drug); GCSF (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Tianjin SinoBiotech Ltd.

Official(s) and/or principal investigator(s):
Binhe Xu, MD, Principal Investigator, Affiliation: CAMS

Overall contact:
Binghe Xu, MD, Phone: 86 10 67781331

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.

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: The mean of duration for class IV neutrophilic granulocytopenia

Secondary outcome:

The mean of duration for class IV neutrophilic granulocytopenia

The mean of duration for ANC up to 2.0×109/L

ANC

The usage of antibiotics

febrile neutropenia

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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Female.

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

Binghe Xu, MD, Phone: 86 10 67781331

Cancer Hospital, Chinese Academy of Medical Scienses, Beijing 100021, China; Recruiting
Binghe Xu, MD

Starting date: December 2014
Last updated: June 4, 2015