Fusion Protein rHSA/GCSFclinical Study on Breast Cancer Patients

Sponsor

Tianjin SinoBiotech Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT03246009

Collaborator

(none)

Enrollment

Location

Arms

14.6

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Chemotherapy-induced Neutropenia Cancer, Breast	Drug: rHSA/GCSF Drug: rHSA/GCSF Drug: rHSA/GCSF Drug: rHSA/GCSF Drug: rHSA/GCSF Drug: rHSA/GCSF	Phase 1

Detailed 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

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 21, 2016

Actual Primary Completion Date :

Apr 10, 2017

Actual Study Completion Date :

Apr 10, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: single injection-1.8mg rHSA/GCSF,injection,1.8mg,Single subcutaneous injection,Duration 1 day	Drug: rHSA/GCSF single injection-1.8mg
Experimental: single injection-2.1mg rHSA/GCSF,injection,2.1mg,Single subcutaneous injection,Duration 1 day	Drug: rHSA/GCSF single injection-2.1mg
Experimental: single injection-2.4mg rHSA/GCSF,injection,2.4mg,Single subcutaneous injection,Duration 1 day	Drug: rHSA/GCSF single injection-2.4mg
Experimental: multiple injection-1.8mg rHSA/GCSF,injection,1.8mg, subcutaneous injection,Duration 4 day,A total of 2 injections, each interval of 3 days.	Drug: rHSA/GCSF multiple injection-1.8mg
Experimental: multiple injection-2.1mg rHSA/GCSF,injection,2.1mg, subcutaneous injection,Duration 4 day,A total of 2 injections, each interval of 3 days.	Drug: rHSA/GCSF multiple injection-2.1mg
Experimental: multiple injection-2.4mg rHSA/GCSF,injection,2.4mg, subcutaneous injection,Duration 4 day,A total of 2 injections, each interval of 3 days.	Drug: rHSA/GCSF multiple injection-2.4mg

Outcome Measures

Primary Outcome Measures

Number of adverse events [14 days]
Number of participants with AE as a measure for safety and tolerability after single and multiple dose of rHSA/GCSF

Secondary Outcome Measures

AUC [14 days]
AUC after single and multiple dose of rHSA/GCSF

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.