Fusion Protein rHSA/GCSFclinical Study on Breast Cancer Patients

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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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

Conditions
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Chemotherapy-induced Neutropenia, Cancer, Breast

Intervention / Treatment
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* Drug: rHSA/GCSF
* Drug: rHSA/GCSF
* Drug: rHSA/GCSF
* Drug: rHSA/GCSF
* Drug: rHSA/GCSF
* Drug: rHSA/GCSF


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC | AUC after single and multiple dose of rHSA/GCSF | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neutropenia, Chemotherapy, rHSA/GCSF