Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-01-03 @ 6:29 AM
Study NCT ID:
NCT00501332
Status:
UNKNOWN
Last Update Posted:
2007-12-24
First Post:
2007-07-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Maxy-G34 in Breast Cancer Patients Treated With TAC (Docetaxel, Adriamycin, Cyclophosphamide) Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009503', 'term': 'Neutropenia'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C545207', 'term': 'Maxy G34'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'lastUpdateSubmitDate': '2007-12-19', 'studyFirstSubmitDate': '2007-07-12', 'studyFirstSubmitQcDate': '2007-07-12', 'lastUpdatePostDateStruct': {'date': '2007-12-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the duration of grade 4 neutropenia after administration of Maxy-G34 in chemotherapy cycle 1.', 'timeFrame': 'over 1 cycle of TAC chemotherapy (approximately 3 weeks)'}], 'secondaryOutcomes': [{'measure': 'To determine the duration of grade 4 neutropenia after administration of Maxy-G34 in chemotherapy cycles 2-6.', 'timeFrame': 'over cycles 2-6 of TAC chemotherapy (approximately from weeks 4-18)'}, {'measure': 'To determine the incidence of grade 4 neutropenia after administration of each of the 6 doses of Maxy-G34.', 'timeFrame': 'over all 6 cycles of TAC chemotherapy (approximately 18 weeks)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['neutropenia', 'breast', 'cancer', 'chemotherapy'], 'conditions': ['Chemotherapy-Induced Neutropenia', 'Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is an investigation of the safety and efficacy of Maxy-G34 in breast cancer patients treated with TAC chemotherapy. Maxy-G34 will be given as a single injection during each cycle of chemotherapy, for a planned total of six chemotherapy cycles.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Males and females at least 18 years of age\n2. Diagnosis of high-risk stage I, II or IIIa breast cancer suitable for adjuvant TAC chemotherapy as based on investigator judgment\n3. Candidates for TAC chemotherapy, and no prior treatment with anthracyclines\n\nKey Exclusion Criteria:\n\n1. Received chemotherapy within last 3 month prior to screening, or expected to receive any chemotherapy other than TAC and / or immunotherapy between screening and 30 days after last planned study drug administration\n2. Any clinically significant findings on history or examination that, in the opinion of the investigator, would preclude administration of TAC chemotherapy in the full dose, including abnormal liver function, inadequate cardiac function or clinically significant cardiac disease, neuropathy or other disease\n3. Prior bone marrow or peripheral blood hematopoietic stem cell transplant\n4. Any active cancer or history of prior malignancy within the last 5 years except carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin or any surgically cured malignancy diagnosed 5 years or more before diagnosis of breast cancer'}, 'identificationModule': {'nctId': 'NCT00501332', 'briefTitle': 'Evaluation of Maxy-G34 in Breast Cancer Patients Treated With TAC (Docetaxel, Adriamycin, Cyclophosphamide) Chemotherapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Maxygen Holdings Ltd.'}, 'officialTitle': 'A Phase IIa, Open Label, Controlled, Dose Ranging Study of Maxy-G34 as an Adjunct to TAC Chemotherapy in High-Risk Patients With Stage I, II, or IIIa Breast Cancer.', 'orgStudyIdInfo': {'id': 'MP-CL-30166'}, 'secondaryIdInfos': [{'id': 'EUDRACT No.: 2006-006565-16'}, {'id': 'PAREXEL 84728'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Biological: Maxy-G34']}], 'interventions': [{'name': 'Maxy-G34', 'type': 'BIOLOGICAL', 'otherNames': ['pegylated recombinant human G-CSF'], 'description': 'Maxy-G34 will be administered by subcutaneous injection during each of 6 TAC chemotherapy cycles.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bydgoszcz', 'status': 'RECRUITING', 'country': 'Poland', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'city': 'Gdansk', 'status': 'RECRUITING', 'country': 'Poland', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'city': 'Lublin', 'status': 'RECRUITING', 'country': 'Poland', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'city': 'Alba Iulia', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Romania', 'geoPoint': {'lat': 46.06667, 'lon': 23.58333}}, {'city': 'Bucharest', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Romania', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Jud. Bacau', 'status': 'RECRUITING', 'country': 'Romania'}, {'city': 'Suceava', 'status': 'RECRUITING', 'country': 'Romania', 'geoPoint': {'lat': 47.63333, 'lon': 26.25}}, {'city': 'Timișoara', 'status': 'RECRUITING', 'country': 'Romania', 'geoPoint': {'lat': 45.75372, 'lon': 21.22571}}, {'city': 'Leningrad Region', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Russia'}, {'city': 'Moscow', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow Area', 'status': 'RECRUITING', 'country': 'Russia'}, {'city': 'Ryazan', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Russia', 'geoPoint': {'lat': 54.62696, 'lon': 39.70415}}, {'city': 'Saint Petersburg', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Russia', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Dnipropetrovsk', 'status': 'RECRUITING', 'country': 'Ukraine', 'geoPoint': {'lat': 48.46664, 'lon': 35.04066}}, {'city': 'Uzhhorod', 'status': 'RECRUITING', 'country': 'Ukraine', 'geoPoint': {'lat': 48.6242, 'lon': 22.2947}}], 'centralContacts': [{'name': 'Doris Apt', 'role': 'CONTACT', 'email': 'Doris.Apt@maxygen.com', 'phone': '650-298-5367'}], 'overallOfficials': [{'name': 'Santosh Vetticaden, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Maxygen, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maxygen Holdings Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Maxygen ApS', 'class': 'INDUSTRY'}, {'name': 'Maxygen, Inc.', 'class': 'INDUSTRY'}, {'name': 'Parexel', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Santosh Vetticaden, MD. Chief Medical Officer.', 'oldOrganization': 'Maxygen, Inc.'}}}}