Fusion Protein rHSA/GCSFclinical Study on Breast Cancer Patients

Cancer, Breast Clinical Trial

Official title:

Efficacy and Safety Phase Ib 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: NCT03246009
• Other study ID #: RG01N-1399
• Status: Completed
• Phase: Phase 1
• First received: August 8, 2017
• Last updated: August 9, 2017
• Start date: January 21, 2016
• Est. completion date: April 10, 2017

Study information

• Verified date: August 2017
• 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 tolerance and safety of the rHSA/GCSF in breast cancer patients with different doses and multiple injections.

To observe the pharmacokinetic characteristics of recombinant human serum albumin /granulocyte colony-stimulating factor fusion protein after single and multiple administration

Description:

This experiment adopts the method of multicenter, open, dose escalation study injection with recombinant human blood clean protein/granulocyte stimulating factor fusion protein after single and multiple doses of tolerance, security, and pharmacokinetic characteristics.

Breast cancer patients with reduced white blood cells after chemotherapy were selected as subjects of this study.

The three research doses that were to be incremented were 1.8 mg, 2.1mg and 2.4mg respectively, each of which was studied by single and multiple doses.

Single dose of medicine, dose-climbing study.Two doses of the drug, dose-climbing study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 10, 2017
• Est. primary completion date: April 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 18-65.

• Diagnosed breast cancer,received chemotherapy.

• ECOG performance status 0 or 1.

• ANC=1.5×10 9/L, PLT=100×10 9/L. No bone marrow metastasis,blood coagulation function normally, no Hemorrhagic tendency.

• Leukocyte reduction occurred after chemotherapy,WBC=3.0x109/L or ANC=1.5x109/L.

• No obvious abnormal ecg examination.

• Cr,TBIL, AST, ALT=1.5×ULN,no serious underlying disease.

• 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.

• Received antibiotic treatment within 72 hours before chemotherapy.

• Long-term use of hormones or immunosuppressive agents.

• Severe mental or neurological disorders.

• 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

• Breast Neoplasms
• Cancer, Breast
• Chemotherapy-induced Neutropenia
• Neutropenia

Intervention

Drug:
• rHSA/GCSF
single injection-1.8mg
• rHSA/GCSF
single injection-2.1mg
• rHSA/GCSF
single injection-2.4mg
• rHSA/GCSF
multiple injection-1.8mg
• rHSA/GCSF
multiple injection-2.1mg
• rHSA/GCSF
multiple injection-2.4mg

Locations

Country	Name	City	State
China	Chinese Academy of Medical Sciences Cancer Hospital	Beijing	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	Number of adverse events	Number of participants with AE as a measure for safety and tolerability after single and multiple dose of rHSA/GCSF	14 days
Secondary	AUC	AUC after single and multiple dose of rHSA/GCSF	14 days