Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-27 @ 11:58 PM
Study NCT ID:
NCT00043394
Status:
COMPLETED
Last Update Posted:
2009-03-12
First Post:
2002-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CPG 7909 Plus Herceptin® In Patients With 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': 'C483020', 'term': 'ProMune'}, {'id': 'D000068878', 'term': 'Trastuzumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2003-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-03-11', 'studyFirstSubmitDate': '2002-08-08', 'studyFirstSubmitQcDate': '2002-08-09', 'lastUpdatePostDateStruct': {'date': '2009-03-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase I: To evaluate the safety and tolerability of several dose levels of CPG 7909 (up to a maximum of 0.16 mg/kg) and to determine the maximum tolerated dose (MTD)* of CPG 7909 in combination with Herceptin®', 'timeFrame': '24 weeks'}, {'measure': 'Phase II: To evaluate tumor response and safety of CPG 7909 (at the MTD as determined in Phase I) in combination with Herceptin® in patients with metastatic breast cancer.', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'Phase I To evaluate tumor response, duration of response, time to disease progression, ECOG performance status, and survival time.', 'timeFrame': '24 weeks'}, {'measure': 'Phase II To evaluate duration of response, time to disease progression, ECOG performance status, and survival time.', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CpG 7909 subcutaneous injection combination with Herceptin® metastatic breast cancer.'], 'conditions': ['Carcinoma, Breast']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=C015&StudyName=CPG%207909%20Plus%20Herceptin%AE%20In%20Patients%20With%20Metastatic%20Breast%20Cancer', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To determine the safety and efficacy of CPG 7909 Injection given with Herceptin to patients with metastatic breast cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically confirmed breast cancer with metastases\n* Tumor that has overexpression of HER2 as documented by being either FISH-positive or HER2/neu 3+ confirmed by immunohistochemistry\n* Patients may have had up to three prior chemotherapy regimens for metastatic disease, which may have been given in combination with Herceptin® and which may have been discontinued due to toxicities. In addition, patients may have had adjuvant chemotherapy.\n* Phase II only: Must have measurable disease by RECIST criteria (defined in section 8) with at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \\> 20 mm with conventional techniques, or as \\> 10 mm with spiral CT scan\n\nExclusion Criteria:\n\n* Any prior therapy with anthracycline + Herceptin® concurrently\n* Significant cardiovascular disease (e.g., NYHA class 3 congestive heart failure, myocardial infarction within the past 6 months, unstable angina; coronary angioplasty within the past 6 months, uncontrolled atrial or ventricular cardiac arrhythmias) or left ventricular ejection fraction \\< 50%\n* Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, autoimmune thrombocytopenia"}, 'identificationModule': {'nctId': 'NCT00043394', 'briefTitle': 'CPG 7909 Plus Herceptin® In Patients With Metastatic Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase I/II Open Label, Multi-Center, Dose-Escalation Study Of Subcutaneous CPG 7909 Plus Herceptin® In Patients With Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'C015'}, 'secondaryIdInfos': [{'id': 'A8501021, CO15'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': '0.04 mg/kg CpG 7909', 'interventionNames': ['Drug: 0.04 mg/kg CpG 7909', 'Drug: Herceptin®']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': '0.08 mg/kg CpG 7909', 'interventionNames': ['Drug: 0.08 mg/kg CpG 7909', 'Drug: Herceptin®']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'description': '0.12 mg/kg CpG 7909 Injection once weekly', 'interventionNames': ['Drug: 0.12 mg/kg CpG 7909', 'Drug: Herceptin®']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4', 'description': '0.16 mg/kg CpG 7909', 'interventionNames': ['Drug: 0.16 mg/kg CpG 7909', 'Drug: Herceptin®']}], 'interventions': [{'name': '0.04 mg/kg CpG 7909', 'type': 'DRUG', 'otherNames': ['PF-03512676, ProMune'], 'description': '0.04 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks', 'armGroupLabels': ['Cohort 1']}, {'name': 'Herceptin®', 'type': 'DRUG', 'otherNames': ['Trastuzumab'], 'description': "Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.", 'armGroupLabels': ['Cohort 1']}, {'name': '0.08 mg/kg CpG 7909', 'type': 'DRUG', 'otherNames': ['PF-03512676, ProMune'], 'description': '0.08 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks', 'armGroupLabels': ['Cohort 2']}, {'name': 'Herceptin®', 'type': 'DRUG', 'otherNames': ['Trastuzumab'], 'description': "Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.", 'armGroupLabels': ['Cohort 2']}, {'name': '0.12 mg/kg CpG 7909', 'type': 'DRUG', 'otherNames': ['PF-03512676, ProMune'], 'description': '0.12 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks', 'armGroupLabels': ['Cohort 3']}, {'name': 'Herceptin®', 'type': 'DRUG', 'otherNames': ['Trastuzumab'], 'description': "Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.", 'armGroupLabels': ['Cohort 3']}, {'name': '0.16 mg/kg CpG 7909', 'type': 'DRUG', 'otherNames': ['PF-03512676, ProMune'], 'description': '0.16 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks', 'armGroupLabels': ['Cohort 4']}, {'name': 'Herceptin®', 'type': 'DRUG', 'otherNames': ['Trastuzumab'], 'description': "Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.", 'armGroupLabels': ['Cohort 4']}]}, 'contactsLocationsModule': {'locations': 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Investigational Site', 'geoPoint': {'lat': 26.13421, 'lon': -80.23184}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48126-2641', 'city': 'Dearborn', 'state': 'Michigan', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 42.32226, 'lon': -83.17631}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48322-3013', 'city': 'West Bloomfield', 'state': 'Michigan', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 42.56891, 'lon': -83.38356}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '05401-3456', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc.'}}}}