Ignite Creation Date:
2025-12-24 @ 1:40 PM
Ignite Modification Date:
2026-01-06 @ 5:52 PM
Study NCT ID:
NCT00251095
Status:
TERMINATED
Last Update Posted:
2009-06-04
First Post:
2005-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Safety and Efficacy of TOCOSOL(R) Paclitaxel Versus Taxol(R) for Treatment of Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D017239', 'term': 'Paclitaxel'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 821}}, 'statusModule': {'whyStopped': 'Failed primary endpoint', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-02', 'studyFirstSubmitDate': '2005-11-08', 'studyFirstSubmitQcDate': '2005-11-08', 'lastUpdatePostDateStruct': {'date': '2009-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rates', 'timeFrame': 'Based on enrollment'}, {'measure': 'Toxicities', 'timeFrame': 'Based on enrollment'}], 'secondaryOutcomes': [{'measure': 'Median overall survival', 'timeFrame': 'Based on enrollment'}, {'measure': 'Progression-free survival', 'timeFrame': 'Based on enrollment'}, {'measure': 'Time-to-disease progression', 'timeFrame': 'Based on enrollment'}]}, 'conditionsModule': {'keywords': ['Metastatic Breast Cancer'], 'conditions': ['Breast Neoplasm']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the objective response rates of patients randomized to receive either TOCOSOL(R) Paclitaxel or Taxol(R) (paclitaxel injection) administered every week to patients with metastatic breast cancer. The study hypothesis is that the objective response rate with TOCOSOL Paclitaxel given every week is non-inferior to that observed with Taxol given every week.', 'detailedDescription': 'Female patients with first or second line metastatic breast cancer will be randomized to receive either weekly TOCOSOL Paclitaxel or weekly Taxol (paclitaxel injection). Patients will undergo radiographic imaging of their disease to assess response to therapy. The primary endpoint of this study is a comparison of the objective response rates observed in patients receiving TOCOSOL Paclitaxel, to those receiving Taxol. Time-to-disease progression and overall survival will also be compared. The toxicities of the two treatment regimens will be compared.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with histologic diagnosis of breast carcinoma\n* Stage IV (M1) disease\n* Adult (18 years of age or older) patients\n\nExclusion Criteria:\n\n* Patients treated with a taxane within the past year\n* Patients whose tumor tissue is known to show over expression of HER2/neu'}, 'identificationModule': {'nctId': 'NCT00251095', 'briefTitle': 'Comparison of Safety and Efficacy of TOCOSOL(R) Paclitaxel Versus Taxol(R) for Treatment of Metastatic Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Achieve Life Sciences'}, 'officialTitle': 'A Multicenter Phase 3, Randomized Comparison of the Safety and Efficacy of Weekly TOCOSOL(R) Paclitaxel vs. Weekly Paclitaxel Injection in the Treatment of Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'SON-8184-1075'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Taxol', 'description': 'Taxol 80mg/m2/week', 'interventionNames': ['Drug: Taxol']}, {'type': 'EXPERIMENTAL', 'label': 'TOCOSOL', 'description': 'TOCOSOL Paclitaxel', 'interventionNames': ['Drug: TOCOSOL Paclitaxel']}], 'interventions': [{'name': 'Taxol', 'type': 'DRUG', 'armGroupLabels': ['Taxol']}, {'name': 'TOCOSOL Paclitaxel', 'type': 'DRUG', 'description': '100 mg/m2/week', 'armGroupLabels': ['TOCOSOL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94704', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'Alta Bates Comprehensive Cancer Center', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '92270', 'city': 'Rancho Mirage', 'state': 'California', 'country': 'United States', 'facility': 'Desert Hematology Oncology Medical Group', 'geoPoint': {'lat': 33.73974, 'lon': -116.41279}}, {'zip': '95204', 'city': 'Stockton', 'state': 'California', 'country': 'United States', 'facility': 'Stockton Hematology Oncology', 'geoPoint': {'lat': 37.9577, 'lon': -121.29078}}, {'zip': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '83712', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Mountain State Tumor Institute', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '49085', 'city': 'Saint Joseph', 'state': 'Michigan', 'country': 'United States', 'facility': 'Oncology Care Associates', 'geoPoint': {'lat': 42.10976, 'lon': -86.48002}}, {'zip': '48076', 'city': 'Southfield', 'state': 'Michigan', 'country': 'United States', 'facility': 'Southfield Oncology Institute, Inc', 'geoPoint': {'lat': 42.47337, 'lon': -83.22187}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Norris Cotton Cancer Center, Dartmouth Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '07109', 'city': 'Belleville', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Essex Oncology of North Jersey', 'geoPoint': {'lat': 40.79371, 'lon': -74.15014}}, {'zip': '58501', 'city': 'Bismarck', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Mid Dakota Clinic', 'geoPoint': {'lat': 46.80833, 'lon': -100.78374}}, {'zip': '43235', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Hematology Oncology Consultants, Inc', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '37404', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Chattanooga Oncology & Hematology Associates, PC', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'The Sarah Cannon Research Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '79410', 'city': 'Lubbock', 'state': 'Texas', 'country': 'United States', 'facility': 'Joe Arrington Cancer Research and Treatment Center', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Achieve Life Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Monica S. Krieger, VP Regulatory Affairs', 'oldOrganization': 'OncoGenex Pharmaceuticals'}}}}