Study to Assess the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GW003 in Patients With Breast Cancer
NCT ID: NCT02725606
Last Updated: 2017-08-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
30 participants
INTERVENTIONAL
2016-03-31
2017-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pegylated Recombinant Human G-CSF
100ug/kg 6 subjects (2 subjects per GW003 cohort)
Pegylated Recombinant Human G-CSF
subcutaneous
GW003 300ug/kg
6-8 subjects
GW003
subcutaneous
GW003 650ug/kg
6-8 subjects
GW003
subcutaneous
GW003 850ug/kg
6-8 subjects
GW003
subcutaneous
Interventions
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Pegylated Recombinant Human G-CSF
subcutaneous
GW003
subcutaneous
Eligibility Criteria
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Inclusion Criteria
* 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:
1. Absolute neutrophil count(ANC)≥1.5 x 10\^9/L
2. Blood platelet(PLT)≥100 x 10\^9/L
3. Serum creatinine(sCr)≤1.5 times the upper limit of normal(ULN)
4. Total bilirubin(TBIL)≤1.5×ULN
5. Aspartate aminotransferase(AST) /serum glutamic-oxaloacetic transaminase(SGOT) and/or alanine aminotransferase(ALT)/serum glutamic pyruvic transaminase(SGPT) ≤ 2.5 x ULN
6. Hemoglobin(Hb)\>9 g/dL
7. Alkaline phosphatase(ALP)≤1.5×ULN
* Expected to comply with protocol
* With urine human chorionic gonadotropin (hCG) negative
* Signed informed consent
Exclusion Criteria
* 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
18 Years
70 Years
FEMALE
No
Sponsors
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Jiangsu T-Mab Biopharma Co.,Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Xichun Hu
Role: PRINCIPAL_INVESTIGATOR
Principal Investigator
Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Tmab-GW003-NP-04
Identifier Type: -
Identifier Source: org_study_id
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