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

Chemotherapy-induced Neutropenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02465801
• Other study ID #: RG01N-0778
• Status: Completed
• Phase: Phase 2
• First received: November 17, 2014
• Last updated: July 16, 2017
• Start date: December 16, 2014
• Est. completion date: April 26, 2016

Study information

• Verified date: November 2014
• Source: Tianjin SinoBiotech Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: April 26, 2016
• Est. primary completion date: December 23, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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 ? 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

Related Conditions & MeSH terms

• Chemotherapy-induced Neutropenia
• Neutropenia

Intervention

Drug:
• HSA-GCSF 1.2 mg
Human Serum Albumin GCSF 1.2mg at day 3 and Day 7
• HSA-GCSF 1.5 mg
Human Serum Albumin GCSF 1.5 mg at day 3 and Day 7
• GCSF
GCSF 5 mcg/kg/day

Locations

Country	Name	City	State
China	Cancer Hospital, Chinese Academy of Medical Scienses	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin SinoBiotech Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean of duration for class IV neutrophilic granulocytopenia		4 weeks
Secondary	The mean of duration for class IV neutrophilic granulocytopenia		8 weeks
Secondary	The mean of duration for ANC up to 2.0×109/L		8 weeks
Secondary	ANC		8 weeks
Secondary	The usage of antibiotics		8 weeks
Secondary	febrile neutropenia		8 weeks