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

NCT ID: NCT02465801

Last Updated: 2017-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-16
• Study Completion Date: 2016-04-26

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.

Conditions

Chemotherapy-induced Neutropenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

HSA-GCSF 1.2 mg

Intervention Type: DRUG

Human Serum Albumin GCSF 1.2mg at day 3 and Day 7

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

Group Type: EXPERIMENTAL

HSA-GCSF 1.5 mg

Intervention Type: DRUG

Human Serum Albumin GCSF 1.5 mg at day 3 and Day 7

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

Group Type: ACTIVE_COMPARATOR

GCSF

Intervention Type: DRUG

GCSF 5 mcg/kg/day

Interventions

HSA-GCSF 1.2 mg

Human Serum Albumin GCSF 1.2mg at day 3 and Day 7

Intervention Type: DRUG

HSA-GCSF 1.5 mg

Human Serum Albumin GCSF 1.5 mg at day 3 and Day 7

Intervention Type: DRUG

GCSF

GCSF 5 mcg/kg/day

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tianjin SinoBiotech Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Binhe Xu, MD

Role: PRINCIPAL_INVESTIGATOR

CAMS

Locations

Cancer Hospital, Chinese Academy of Medical Scienses

Beijing, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 33789616 (View on PubMed)

Other Identifiers

RG01N-0778

Identifier Type: -

Identifier Source: org_study_id