Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-01-19 @ 8:55 PM
Study NCT ID:
NCT00087958
Status:
COMPLETED
Last Update Posted:
2009-05-01
First Post:
2004-07-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravenous RPR109881 in Male or Female Patients With Advanced Breast Cancer Who no Longer Respond to Anthracycline, Taxane and Capecitabine Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Ireland']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C531079', 'term': 'larotaxel'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 168}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-30', 'studyFirstSubmitDate': '2004-07-16', 'studyFirstSubmitQcDate': '2004-07-19', 'lastUpdatePostDateStruct': {'date': '2009-05-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate as assessed by Response Evaluation Criteria in Solid Tumors'}], 'secondaryOutcomes': [{'measure': 'Progression free survival, overall survival, composite event of CR, PR and stable disease > or = to 12 weeks'}, {'measure': 'Time to tumor response and duration of response.'}, {'measure': 'Safety analyses based on incidence, severity, chronicity and cumulative nature of TEAEs.'}]}, 'conditionsModule': {'keywords': ['Metastatic breast cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical trial is to determine if the investigational drug is able to reduce/shrink advanced breast cancer tumors in patients who no longer benefit from anthracyclines, taxanes and capecitabine.', 'detailedDescription': 'All patients in this trial will receive the investigational (chemotherapy) drug at an optimal dose as determined by previous clinical trials. The investigational drug is given through a vein once every three weeks. This drug prevents tumor cells from dividing, so they may stop growing or die.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIn order to be eligible for this trial you must:\n\n* Have a diagnosis of breast cancer that is now metastatic (meaning the cancer has spread beyond its original location) or a recurrence of the cancer in its original location that cannot be removed by surgery.\n* Have received previous treatment with anthracyclines (e.g. doxorubicin \\[Adriamycin or Doxil\\] or epirubicin \\[Ellence\\]), taxanes (paclitaxel \\[Taxol or Abraxane\\] or docetaxel \\[Taxotere\\]) and capecitabine (e.g. Xeloda) for your breast cancer and your doctor has determined that these treatments are no longer of benefit to you.\n* Be at least 18 years of age\n* Not be taking other treatments for your cancer at the time you enter the trial.\n* Not be pregnant\n* Additionally, there are other criteria for study entry that a doctor participating in this study will need to review in detail with you and clinical assessments may need to be performed (lab tests, CT scans).\n\nExclusion Criteria:\n\n* None listed here. Can be discussed with your doctor.'}, 'identificationModule': {'nctId': 'NCT00087958', 'briefTitle': 'Intravenous RPR109881 in Male or Female Patients With Advanced Breast Cancer Who no Longer Respond to Anthracycline, Taxane and Capecitabine Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Phase II Multi-Center, Open-Label, Non-Randomized Study of Intravenous RPR109881 Given Every 3 Weeks in Patients With Metastatic Breast Cancer Progressing After Therapy With Anthracyclines, Taxanes and Capecitabine', 'orgStudyIdInfo': {'id': 'EFC6088'}, 'secondaryIdInfos': [{'id': 'XRP9881B/2001'}, {'id': 'EUDRACT : 2004-000572-14'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'XRP9881', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08807', 'city': 'Bridgewater', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 40.60079, 'lon': -74.64815}}, {'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Diegem', 'country': 'Belgium', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 50.89727, 'lon': 4.43354}}, {'city': 'Laval', 'country': 'Canada', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 45.56995, 'lon': -73.692}}, {'city': 'Bogotá', 'country': 'Colombia', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'city': 'Hørsholm', 'country': 'Denmark', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 55.88098, 'lon': 12.50111}}, {'city': 'Paris', 'country': 'France', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Gouda', 'country': 'Netherlands', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 52.01667, 'lon': 4.70833}}, {'city': 'Midrand', 'country': 'South Africa', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': -25.976, 'lon': 28.118}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'ICD CSD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'ICD Study Director', 'oldOrganization': 'sanofi-aventis'}}}}