Status:
UNKNOWN
Study to Assess the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GW003 in Patients With Breast Cancer
Lead Sponsor:
Jiangsu T-Mab Biopharma Co.,Ltd
Conditions:
Chemotherapy-induced Neutropenia
Eligibility:
FEMALE
18-70 years
Phase:
PHASE1
Brief Summary
The purpose of the present trial is to evaluate the safety, tolerability and pharmacokinetics(PK)/pharmacodynamics(PD) of single subcutaneous injection of GW003 in breast cancer patients. Moreover, th...
Detailed Description
This is an single-center, open-label, randomized, active-controlled phase I study evaluating tolerability and pharmacokinetics/pharmacodynamics of single subcutaneous injections of GW003 in the breast...
Eligibility Criteria
Inclusion
- Aged 18 years to 70 years, female
- Patients with histologically-confirmed breast cancer and plan to accept adjuvant chemotherapy(epirubicin plus cyclophosphamide)
- Have an Eastern Cooperative Oncology Group(ECOG) performance status≤2
- Have no clinically significant impairment in cardiac, liver and kidney
- Adequate hematologic, hepatic and renal function which should meet the following requirements:
- Absolute neutrophil count(ANC)≥1.5 x 10\^9/L
- Blood platelet(PLT)≥100 x 10\^9/L
- Serum creatinine(sCr)≤1.5 times the upper limit of normal(ULN)
- Total bilirubin(TBIL)≤1.5×ULN
- Aspartate aminotransferase(AST) /serum glutamic-oxaloacetic transaminase(SGOT) and/or alanine aminotransferase(ALT)/serum glutamic pyruvic transaminase(SGPT) ≤ 2.5 x ULN
- Hemoglobin(Hb)\>9 g/dL
- Alkaline phosphatase(ALP)≤1.5×ULN
- Expected to comply with protocol
- With urine human chorionic gonadotropin (hCG) negative
- Signed informed consent
Exclusion
- With acute infection
- With history of bone marrow transplant and/or stem cell transplant
- With primary hematological diseases, such as myelodysplastic syndromes, aplastic anemia, sickle cell anemia
- Received surgery within 3 weeks before chemotherapy
- Received G-CSF within 4 weeks before involved in this study
- Females who are pregnant or lactating
- Participated in other clinical trials at the same time or within 4 weeks before screening
- Known allergy to chemotherapy drugs,recombinant human granulocyte-colony stimulating factor rh(rhG-CSF) or any other biological products
- With cacoethic addiction such as drug abuse or alcoholism
- With other cases which is not suitable for this study judged by investigator
Key Trial Info
Start Date :
March 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02725606
Start Date
March 1 2016
End Date
September 1 2017
Last Update
August 18 2017
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032