Fusion Protein rHSA/GCSFclinical Study on Breast Cancer Patients

Tianjin SinoBiotech

Status and phase: Completed; Phase 1

Conditions: Chemotherapy-induced Neutropenia; Cancer, Breast

Treatments: Drug: rHSA/GCSF

Study type: Interventional

Funder types: Industry

Identifiers

NCT03246009

RG01N-1399

Details and patient eligibility

About

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

Full 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

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 6 patient groups

single injection-1.8mg

Experimental group

Description:

rHSA/GCSF,injection,1.8mg,Single subcutaneous injection,Duration 1 day

Treatment:

Drug: rHSA/GCSF

Drug: rHSA/GCSF

Drug: rHSA/GCSF

Drug: rHSA/GCSF

Drug: rHSA/GCSF

Drug: rHSA/GCSF

single injection-2.1mg

Experimental group

Description:

rHSA/GCSF,injection,2.1mg,Single subcutaneous injection,Duration 1 day

Treatment:

Drug: rHSA/GCSF

Drug: rHSA/GCSF

Drug: rHSA/GCSF

Drug: rHSA/GCSF

Drug: rHSA/GCSF

Drug: rHSA/GCSF

single injection-2.4mg

Experimental group

Description:

rHSA/GCSF,injection,2.4mg,Single subcutaneous injection,Duration 1 day

Treatment:

Drug: rHSA/GCSF

Drug: rHSA/GCSF

Drug: rHSA/GCSF

Drug: rHSA/GCSF

Drug: rHSA/GCSF

Drug: rHSA/GCSF

multiple injection-1.8mg

Experimental group

Description:

rHSA/GCSF,injection,1.8mg, subcutaneous injection,Duration 4 day,A total of 2 injections, each interval of 3 days.

Treatment:

Drug: rHSA/GCSF

Drug: rHSA/GCSF

Drug: rHSA/GCSF

Drug: rHSA/GCSF

Drug: rHSA/GCSF

Drug: rHSA/GCSF

multiple injection-2.1mg

Experimental group

Description:

rHSA/GCSF,injection,2.1mg, subcutaneous injection,Duration 4 day,A total of 2 injections, each interval of 3 days.

Treatment:

Drug: rHSA/GCSF

Drug: rHSA/GCSF

Drug: rHSA/GCSF

Drug: rHSA/GCSF

Drug: rHSA/GCSF

Drug: rHSA/GCSF

multiple injection-2.4mg

Experimental group

Description:

rHSA/GCSF,injection,2.4mg, subcutaneous injection,Duration 4 day,A total of 2 injections, each interval of 3 days.

Treatment:

Drug: rHSA/GCSF

Drug: rHSA/GCSF

Drug: rHSA/GCSF

Drug: rHSA/GCSF

Drug: rHSA/GCSF

Drug: rHSA/GCSF