Status:
COMPLETED
Fusion Protein rHSA/GCSFclinical Study on Breast Cancer Patients
Lead Sponsor:
Tianjin SinoBiotech Ltd.
Conditions:
Chemotherapy-induced Neutropenia
Cancer, Breast
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 characteristi...
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 multip...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 21 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2017
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03246009
Start Date
January 21 2016
End Date
April 10 2017
Last Update
August 11 2017
Active Locations (1)
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1
Chinese Academy of Medical Sciences Cancer Hospital
Beijing, Beijing Municipality, China, 100021