Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 2:00 AM
Study NCT ID:
NCT00813605
Status:
COMPLETED
Last Update Posted:
2016-10-27
First Post:
2008-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
QUILT-2.018: Safety & Efficacy of FOLFIRI With AMG 479 or AMG 655 vs FOLFIRI Alone in KRAS-mutant Metastatic Colorectal Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': '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': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C480833', 'term': 'IFL protocol'}, {'id': 'C554537', 'term': 'conatumumab'}, {'id': 'C545764', 'term': 'ganitumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 155}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'dispFirstSubmitDate': '2016-03-07', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-26', 'studyFirstSubmitDate': '2008-12-22', 'dispFirstSubmitQcDate': '2016-03-07', 'studyFirstSubmitQcDate': '2008-12-22', 'dispFirstPostDateStruct': {'date': '2016-04-04', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival', 'timeFrame': 'Length of Study'}], 'secondaryOutcomes': [{'measure': 'Overall Survival, Objective Response, Duration of Response, Time to Response', 'timeFrame': 'Length of Study'}, {'measure': 'Incidence of adverse events', 'timeFrame': 'Length of Study'}, {'measure': 'Significant laboratory abnormalities', 'timeFrame': 'Length of Study'}, {'measure': 'Incidence of antibody formation', 'timeFrame': 'Length of Study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['AMG 655', 'AMG 479', 'Colon Cancer', 'Rectal Cancer', 'Monoclonal Antibody', 'Clinical Trial', 'Colorectal Cancer', 'metastatic colorectal cancer', 'metastatic cancer', 'antibody-2nd line', 'KRAS', 'adenocarcinoma'], 'conditions': ['Metastatic Colorectal Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'This is a phase 2, multicenter, randomized, double-blind, double-dummy, placebo-controlled, three-arm trial to be conducted in the United States, Europe, and Asia. Approximately 150 eligible KRAS-mutant metastatic colorectal cancer subjects who have failed first line fluoropyrimidine and oxaliplatin-based regimen with or without anti-VEGF therapy will be randomized in a 1:1:1 ratio to receive AMG 479 placebo plus AMG 655 with FOLFIRI, or AMG 479 plus AMG 655 placebo with FOLFIRI, or AMG 479 placebo plus AMG 655 placebo with FOLFIRI'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma of colon or rectum in patients with metastatic disease\n* Mutant-type KRAS tumor at screening\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 1\n* Adequate hematology, renal, hepatic, and coagulation function\n\nExclusion Criteria:\n\n* History or known presence of central nervous system metastases\n* History of other malignancy\n* Prior irinotecan-based chemotherapy for advanced/metastatic disease\n* Prior death receptor agonists, or other systemic IGF-1R agonists in any setting\n* Uncontrolled cardiovascular disease'}, 'identificationModule': {'nctId': 'NCT00813605', 'briefTitle': 'QUILT-2.018: Safety & Efficacy of FOLFIRI With AMG 479 or AMG 655 vs FOLFIRI Alone in KRAS-mutant Metastatic Colorectal Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'NantCell, Inc.'}, 'officialTitle': 'A Phase 2, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of FOLFIRI in Combination With AMG 479 or AMG 655 Versus FOLFIRI for the Second-line Treatment of KRAS-mutant Metastatic Colorectal Carcinoma', 'orgStudyIdInfo': {'id': '20060579'}, 'secondaryIdInfos': [{'id': 'QUILT-2.018', 'type': 'OTHER', 'domain': 'NantCell, Inc.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'description': 'AMG 655 10 mg/kg plus AMG 479 placebo in combination with FOLFIRI every 14 days', 'interventionNames': ['Other: FOLFIRI', 'Biological: AMG 655', 'Other: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm C', 'description': 'AMG 479 Placebo plus AMG 655 Placebo in combination with FOLFIRI every 14 days', 'interventionNames': ['Other: FOLFIRI', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B', 'description': 'AMG 479 12 mg/kg plus AMG 655 placebo in combination with FOLFIRI every 14 days', 'interventionNames': ['Other: FOLFIRI', 'Other: Placebo', 'Biological: AMG 479']}], 'interventions': [{'name': 'FOLFIRI', 'type': 'OTHER', 'description': 'Day 1 of each Cycle\n\nCombination Therapy of:\n\nirinotecan 180 mg/m2 90-minute infusion leucovorin 400 mg/m2 2 hour infusion 5-FU 400 mg/m2 IV bolus 5-FU 2,400 mg/m2 46-48 hour infusion', 'armGroupLabels': ['Arm A', 'Arm B', 'Arm C']}, {'name': 'AMG 655', 'type': 'BIOLOGICAL', 'otherNames': ['Conatumumab'], 'description': 'AMG 655 is an investigational, fully human, monoclonal antibody that selectively binds to Death Receptor-5 (DR-5)', 'armGroupLabels': ['Arm A']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Inactive dummy agent (to maintain blind)', 'armGroupLabels': ['Arm A', 'Arm B', 'Arm C']}, {'name': 'AMG 479', 'type': 'BIOLOGICAL', 'description': 'AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1', 'armGroupLabels': ['Arm B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '93454', 'city': 'Santa Maria', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.95303, 'lon': -120.43572}}, {'zip': '80218', 'city': 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