Ignite Creation Date:
2025-12-26 @ 11:47 AM
Ignite Modification Date:
2026-02-25 @ 8:59 PM
Study NCT ID:
NCT02437916
Status:
TERMINATED
Last Update Posted:
2022-11-08
First Post:
2015-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of AMG 228 to Treat Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-04-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2016-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-04', 'studyFirstSubmitDate': '2015-04-03', 'studyFirstSubmitQcDate': '2015-05-07', 'lastUpdatePostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subject incidence of dose limiting toxicities (DLT)', 'timeFrame': '9 months'}, {'measure': 'Subject incidence of treatment-emergent adverse events', 'timeFrame': '9 months'}, {'measure': 'Subject incidence of treatment-related adverse events', 'timeFrame': '9 months'}, {'measure': 'Subject incidence of clinically significant changes in vital signs and physical assessments', 'timeFrame': '9 months'}, {'measure': 'Subject incidence of clinically significant changes in ECGs', 'timeFrame': '9 months'}, {'measure': 'Subject incidence of clinically significant changes in clinical laboratory tests', 'timeFrame': '9 months'}, {'measure': 'AMG 228 maximum observed concentration (Cmax)', 'timeFrame': '9 months'}, {'measure': 'AMG 228 minimum observed concentration (Cmin)', 'timeFrame': '9 months'}, {'measure': 'AMG 228 area under the concentration-time curve (AUC)', 'timeFrame': '9 months'}, {'measure': 'AMG 228 half-life (t1/2)', 'timeFrame': '9 months'}], 'secondaryOutcomes': [{'measure': 'Subject objective response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1', 'timeFrame': '9 months'}, {'measure': 'Incidence of anti-AMG 228 antibody formation', 'timeFrame': '9 months'}, {'measure': 'Activation status and changes in numbers of T regulator cells (Treg)', 'timeFrame': '9 months'}, {'measure': 'Subject objective response per immune-related Response Criteria (irRC)', 'timeFrame': '9 months'}, {'measure': 'Activation status of cytotoxic T lymphocytes (CTL)', 'timeFrame': '9 months'}, {'measure': 'Changes in numbers of cytotoxic T lymphocytes (CTL)', 'timeFrame': '9 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Melanoma', 'Non-small Cell Lung Cancer (NSCLC)', 'Squamous Cell Carcinoma', 'Carcinoma', 'Head and Neck', 'Transitional Cell Carinoma (TCC)', 'Bladder', 'Colorectal', 'Colorectal Cancer (CRC)'], 'conditions': ['Advanced Malignancy', 'Advanced Solid Tumors', 'Cancer', 'Oncology', 'Oncology Patients', 'Tumors', 'Melanoma', 'Non-small Cell Lung Cancer', 'Squamous Cell Carcinoma of the Head and Neck', 'Transitional Cell Carinoma of Bladder', 'Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '30253804', 'type': 'BACKGROUND', 'citation': 'Tran B, Carvajal RD, Marabelle A, Patel SP, LoRusso PM, Rasmussen E, Juan G, Upreti VV, Beers C, Ngarmchamnanrith G, Schoffski P. Dose escalation results from a first-in-human, phase 1 study of glucocorticoid-induced TNF receptor-related protein agonist AMG 228 in patients with advanced solid tumors. J Immunother Cancer. 2018 Sep 25;6(1):93. doi: 10.1186/s40425-018-0407-x.'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, pharmacokinetics, anti-tumor activity, and identify a tolerable dose of AMG 228 in subjects with advanced solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject must have a pathologically documented, definitively diagnosed, advanced solid tumor\n* Adequate hematological, renal, hepatic, and coagulation laboratory assessments\n\nExclusion Criteria:\n\n* Active autoimmune disease, history of autoimmune disease\n* Treatment with immune modulators including\n* Use of warfarin, factor Xa inhibitors, or direct thrombin inhibitors\n* Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 28 days\n* Major surgery within 28 days of study day 1'}, 'identificationModule': {'nctId': 'NCT02437916', 'briefTitle': 'Safety Study of AMG 228 to Treat Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Phase 1 First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 228 in Subjects With Selected Advanced Solid Tumors', 'orgStudyIdInfo': {'id': '20140131'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AMG 228 monotherapy', 'description': 'Part 1 and Part 2 of the study will both be with single agent AMG 228 in different selected tumor types.', 'interventionNames': ['Drug: AMG 228']}], 'interventions': [{'name': 'AMG 228', 'type': 'DRUG', 'description': 'AMG 228 will be administered intravenously', 'armGroupLabels': ['AMG 228 monotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '3050', 'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}