Ignite Creation Date:
2025-12-26 @ 5:17 PM
Ignite Modification Date:
2026-03-03 @ 2:53 AM
Study NCT ID:
NCT02725606
Status:
UNKNOWN
Last Update Posted:
2017-08-18
First Post:
2016-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GW003 in Patients With Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009503', 'term': 'Neutropenia'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D000380', 'term': 'Agranulocytosis'}, {'id': 'D007970', 'term': 'Leukopenia'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-15', 'studyFirstSubmitDate': '2016-03-24', 'studyFirstSubmitQcDate': '2016-03-31', 'lastUpdatePostDateStruct': {'date': '2017-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of adverse events (AEs) and serious adverse events (SAEs) which are related to GW003 as assessed by CTCAE v4.03', 'timeFrame': '21days'}], 'secondaryOutcomes': [{'measure': 'Maximum observed maximum plasma concentration [Cmax]', 'timeFrame': '21days'}, {'measure': 'Time to reach the maximum observed plasma concentration [Tmax]', 'timeFrame': '21days'}, {'measure': 'Area under the plasma concentration-time curve from time zero to infinity[AUC0-inf]', 'timeFrame': '21days'}, {'measure': "Area under the plasma concentration-time curve from time zero to time 't' where t is a defined time point after administration [AUC0-t]", 'timeFrame': '21days'}, {'measure': 'Terminal elimination half-life[T1/2]', 'timeFrame': '21days'}, {'measure': 'Absolute neutrophil count[ANC]', 'timeFrame': '21days', 'description': 'ANC will be detected pre-dose and 12h,24h,48h,72h,96h,120h,144h,168h,192h,216h,240h,264h,360h,408h,480h post-dose.'}, {'measure': 'CD34+ count', 'timeFrame': '21days', 'description': 'CD34+ count will be detected pre-dose and 12h,24h,48h,72h,96h,120h,144h,168h,192h,216h,240h,264h,360h,408h,480h post-dose.'}, {'measure': 'Time to absolute neutrophil count(ANC) recovery', 'timeFrame': '21days', 'description': 'The time of ANC of patients who experienced neutropenia after chemotherapy recover to normal levels.'}, {'measure': 'Incidence of severe neutropenia', 'timeFrame': '21days', 'description': 'The proportion of patients with grade 3 and 4 neutropenia as assessed by CTCAE v4.03.'}, {'measure': 'Duration of severe neutropenia(DSN)', 'timeFrame': '21days', 'description': 'Duration of grade 3 and 4 neutropenia as assessed by CTCAE v4.03.'}, {'measure': 'ANC nadir', 'timeFrame': '21days', 'description': 'The minimum value of ANC throughout the study period.'}, {'measure': 'Frequency of subjects with anti-GW003 antibody', 'timeFrame': '21days', 'description': 'Anti-GW003 antibody will be detected pre-dose and 21d.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Neutropenia', 'Breast Cancer', 'GW003'], 'conditions': ['Chemotherapy-induced Neutropenia']}, 'descriptionModule': {'briefSummary': '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, the efficacy will be assessed preliminary.', 'detailedDescription': '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 cancer patients.GW003 is recombinant human serum albumin/human granulocyte-colony stimulating factor(I)fusion protein .It is a long-acting G-CSF(Granulocyte-Colony Stimulating Factor). In this study, participants will be administered a single dose of GW003. Every subject will only accept one dose. In addition to tolerability and safety, pharmacokinetics/pharmacodynamics, preliminary efficacy and immunogenicity of GW003 will be evaluated as well.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 years to 70 years, female\n* Patients with histologically-confirmed breast cancer and plan to accept adjuvant chemotherapy(epirubicin plus cyclophosphamide)\n* Have an Eastern Cooperative Oncology Group(ECOG) performance status≤2\n* Have no clinically significant impairment in cardiac, liver and kidney\n* Adequate hematologic, hepatic and renal function which should meet the following requirements:\n\n 1. Absolute neutrophil count(ANC)≥1.5 x 10\\^9/L\n 2. Blood platelet(PLT)≥100 x 10\\^9/L\n 3. Serum creatinine(sCr)≤1.5 times the upper limit of normal(ULN)\n 4. Total bilirubin(TBIL)≤1.5×ULN\n 5. Aspartate aminotransferase(AST) /serum glutamic-oxaloacetic transaminase(SGOT) and/or alanine aminotransferase(ALT)/serum glutamic pyruvic transaminase(SGPT) ≤ 2.5 x ULN\n 6. Hemoglobin(Hb)\\>9 g/dL\n 7. Alkaline phosphatase(ALP)≤1.5×ULN\n* Expected to comply with protocol\n* With urine human chorionic gonadotropin (hCG) negative\n* Signed informed consent\n\nExclusion Criteria:\n\n* With acute infection\n* With history of bone marrow transplant and/or stem cell transplant\n* With primary hematological diseases, such as myelodysplastic syndromes, aplastic anemia, sickle cell anemia\n* Received surgery within 3 weeks before chemotherapy\n* Received G-CSF within 4 weeks before involved in this study\n* Females who are pregnant or lactating\n* Participated in other clinical trials at the same time or within 4 weeks before screening\n* Known allergy to chemotherapy drugs,recombinant human granulocyte-colony stimulating factor rh(rhG-CSF) or any other biological products\n* With cacoethic addiction such as drug abuse or alcoholism\n* With other cases which is not suitable for this study judged by investigator'}, 'identificationModule': {'nctId': 'NCT02725606', 'briefTitle': 'Study to Assess the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GW003 in Patients With Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu T-Mab Biopharma Co.,Ltd'}, 'officialTitle': 'A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Human Serum Albumin/Human Granulocyte-Colony Stimulating Factor(I) Fusion Protein for Injection (GW003) in Patients With Breast Cancer', 'orgStudyIdInfo': {'id': 'Tmab-GW003-NP-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pegylated Recombinant Human G-CSF', 'description': '100ug/kg 6 subjects (2 subjects per GW003 cohort)', 'interventionNames': ['Biological: Pegylated Recombinant Human G-CSF']}, {'type': 'EXPERIMENTAL', 'label': 'GW003 300ug/kg', 'description': '6-8 subjects', 'interventionNames': ['Biological: GW003']}, {'type': 'EXPERIMENTAL', 'label': 'GW003 650ug/kg', 'description': '6-8 subjects', 'interventionNames': ['Biological: GW003']}, {'type': 'EXPERIMENTAL', 'label': 'GW003 850ug/kg', 'description': '6-8 subjects', 'interventionNames': ['Biological: GW003']}], 'interventions': [{'name': 'Pegylated Recombinant Human G-CSF', 'type': 'BIOLOGICAL', 'description': 'subcutaneous', 'armGroupLabels': ['Pegylated Recombinant Human G-CSF']}, {'name': 'GW003', 'type': 'BIOLOGICAL', 'description': 'subcutaneous', 'armGroupLabels': ['GW003 300ug/kg', 'GW003 650ug/kg', 'GW003 850ug/kg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xichun Hu', 'role': 'CONTACT', 'email': 'xchu2009@hotmail.com'}], 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Xichun Hu', 'role': 'CONTACT', 'email': 'xchu2009@hotmail.com'}, {'name': 'Guangfu Li', 'role': 'CONTACT', 'email': 'guangfuli@t-mab.com'}], 'overallOfficials': [{'name': 'Xichun Hu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Principal Investigator'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu T-Mab Biopharma Co.,Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}