Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2026-04-09 @ 10:43 AM
Study NCT ID:
NCT02048059
Status:
COMPLETED
Last Update Posted:
2020-02-25
First Post:
2014-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D064726', 'term': 'Triple Negative 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'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C531859', 'term': 'paclitaxel-Angiopep-2 conjugate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'dispFirstSubmitDate': '2017-09-15', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-19', 'studyFirstSubmitDate': '2014-01-21', 'dispFirstSubmitQcDate': '2017-09-20', 'studyFirstSubmitQcDate': '2014-01-27', 'dispFirstPostDateStruct': {'date': '2017-09-28', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intracranial objective response rate (iORR)', 'timeFrame': 'Upon enrollment through end of study period (1 year after last patient is enrolled)'}], 'secondaryOutcomes': [{'measure': 'Duration of intracranial objective response', 'timeFrame': 'Upon enrollment through end of study period (1 year after last patient is enrolled)'}, {'measure': 'Median intracranial progression-free survival (PFS)', 'timeFrame': 'Upon enrollment through end of study period (1 year after last patient is enrolled)'}, {'measure': 'Intracranial PFS rates at 3, 6 and 12 months', 'timeFrame': 'Upon enrollment through end of study period (1 year after last patient is enrolled)'}, {'measure': '6-month overall survival (OS) rate', 'timeFrame': 'Upon enrollment through end of study period (1 year after last patient is enrolled'}, {'measure': 'Extracranial objective response rate (eORR) and duration of response', 'timeFrame': 'Upon enrollment through end of study period (1 year after last patient is enrolled'}, {'measure': 'Number of Patients with adverse events', 'timeFrame': 'Upon enrollment through end of study period (1 year after last patient is enrolled'}, {'measure': 'Plasma pharmacokinetics of ANG1005', 'timeFrame': 'On Day 1 of Cycles 1 and 3', 'description': 'To determine the drug concentration and distribution in the plasma. (AUC, Cmax, T1/2)'}, {'measure': 'Intracranial ORR by modified Response Assessment in Neuro-Oncology (RANO) criteria', 'timeFrame': 'Upon enrollment through end of study period (1 year after last patient is enrolled)'}, {'measure': 'Intracranial clinical benefit rate (iCBR) at 3 and 6 months', 'timeFrame': 'Upon enrollment through end of study period (1 year after last patient is enrolled)'}, {'measure': 'Potential immunogenicity of ANG1005', 'timeFrame': 'Upon enrollment through end of study period (1 year after last patient is enrolled)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ANG1005', 'GRN1005', 'Low-density lipoprotein receptor-related protein (LRP-1)', 'Targeted therapy', 'Breast cancer', 'Brain metastases', 'Brain tumor', 'Blood-brain barrier', 'Trastuzumab', 'Herceptin', 'Paclitaxel', 'Taxol', 'Breast cancer with brain metastases', 'Triple Negative', 'Triple negative breast cancer (TNBC)', 'Herceptin 2 (HER2)-positive', 'HER2-negative', 'Metastatic brain tumors'], 'conditions': ['Breast Cancer', 'Brain Metastases']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/22203732', 'label': 'Safety, pharmacokinetics, and activity of GRN1005, a novel conjugate of angiopep-2, a peptide facilitating brain penetration, and paclitaxel, in patients with advanced solid tumors'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 2 study to see if an investigational drug, ANG1005, can shrink tumor cells in breast cancer patients with recurrent brain metastases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ≥ 18 years old\n2. Breast cancer\n3. Recurrent brain metastases from breast cancer\n4. At least one radiologically-confirmed and measurable metastatic brain lesion ( ≥ 0.5 cm)\n5. Neurologically stable\n6. Karnofsky Performance Status (KPS) score ≥ 70\n7. Adequate hematology and serum chemistry laboratory test results\n8. Expected survival of ≥ 3 months\n\nExclusion Criteria:\n\n1. Prior treatment with ANG1005/GRN1005\n2. Evidence of symptomatic intracranial hemorrhage\n3. Pregnancy or lactation\n4. Inadequate bone marrow reserve\n5. Any evidence of severe or uncontrolled diseases\n6. Patients with the presence of an infection including abscess or fistulae, or known infection with hepatitis B or C or HIV\n7. History of interstitial lung disease or evidence of clinically significant interstitial lung disease\n8. Severe cardiac conduction disturbance\n9. Central nervous system (CNS) disease requiring immediate neurosurgery intervention\n10. Known severe hypersensitivity or allergy to paclitaxel or any of its components'}, 'identificationModule': {'nctId': 'NCT02048059', 'briefTitle': 'ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases', 'organization': {'class': 'INDUSTRY', 'fullName': 'Angiochem Inc'}, 'officialTitle': 'A Phase II, Open-Label, Multi-Center Study of ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases', 'orgStudyIdInfo': {'id': 'ANG1005-CLN-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ANG1005', 'description': 'Participants received ANG1005 intravenously (IV) at a dose of 600 mg/m\\^2 on Day 1 of each 21-day cycle. ANG1005 will be administered for up to a maximum of one year, or until disease progression or adverse events (AE) that are not tolerated.', 'interventionNames': ['Drug: ANG1005']}], 'interventions': [{'name': 'ANG1005', 'type': 'DRUG', 'armGroupLabels': ['ANG1005']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona Cancer Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92093-0698', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UC San Diego Moores Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California - LAC Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California - Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'UC - Irvine Chao Family Comprehensive Cancer Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Cancer Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'GRU Cancer Center - Georgia Regents University', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland - Greenebaum Cancer Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '20892-1903', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Cancer Institute', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Cancer & Hematology Centers of Western Michigan', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '87106', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '11725', 'city': 'Commack', 'state': 'New York', 'country': 'United States', 'facility': 'The Long Islan Brain Tumor Center at Neurological Surgery P.C.', 'geoPoint': {'lat': 40.84288, 'lon': -73.29289}}, {'zip': '27599-7295', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Magee Womens Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Cancer Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Univeristy of Texas Health Science Center in San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Betty Lawrence', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Angiochem Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Angiochem Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}