Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2026-01-10 @ 2:18 PM
Study NCT ID:
NCT00625651
Status:
COMPLETED
Last Update Posted:
2014-04-25
First Post:
2008-02-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1b/2 Study of AMG 655 With mFOLFOX6 and Bevacizumab for First-Line Metastatic Colorectal Cancer
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'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C554537', 'term': 'conatumumab'}, {'id': 'D000068258', 'term': 'Bevacizumab'}], '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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 202}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'dispFirstSubmitDate': '2014-01-15', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-28', 'studyFirstSubmitDate': '2008-02-14', 'dispFirstSubmitQcDate': '2014-01-15', 'studyFirstSubmitQcDate': '2008-02-20', 'dispFirstPostDateStruct': {'date': '2014-02-12', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-04-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'Length of study'}], 'secondaryOutcomes': [{'measure': 'Objective response rate', 'timeFrame': 'Length of study'}, {'measure': 'Duration of response', 'timeFrame': 'Length of study'}, {'measure': 'Time-to-response', 'timeFrame': 'Length of study'}, {'measure': 'Overall survival', 'timeFrame': 'Length of study'}, {'measure': 'AMG 655 pharmacokinetic parameters', 'timeFrame': 'Length of study'}, {'measure': 'The incidence of anti-AMG 655 antibody formation', 'timeFrame': 'Length of study'}]}, 'conditionsModule': {'keywords': ['Colon Cancer', 'Colorectal Cancer', 'Rectal Cancer', 'AMG 655', 'Bevacizumab', 'Modified FOLFOX6', 'mFOLFOX6', 'FOLFOX'], 'conditions': ['Metastatic Colorectal Cancer', 'Colon Cancer', 'Colorectal Cancer', 'Rectal Cancer']}, 'referencesModule': {'references': [{'pmid': '24122767', 'type': 'BACKGROUND', 'citation': 'Fuchs CS, Fakih M, Schwartzberg L, Cohn AL, Yee L, Dreisbach L, Kozloff MF, Hei YJ, Galimi F, Pan Y, Haddad V, Hsu CP, Sabin A, Saltz L. TRAIL receptor agonist conatumumab with modified FOLFOX6 plus bevacizumab for first-line treatment of metastatic colorectal cancer: A randomized phase 1b/2 trial. Cancer. 2013 Dec 15;119(24):4290-8. doi: 10.1002/cncr.28353. Epub 2013 Oct 1.'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'This phase 1/2, multi-center, randomized, double-blind, placebo-controlled trial is designed to evaluate the efficacy and safety of AMG 655 when combined with mFOLFOX6 and bevacizumab compared with mFOLFOX6 and bevacizumab alone in subjects with previously untreated metastatic colorectal cancer (CRC).\n\nThe clinical benefit of AMG 655 in combination with mFOLFOX6 and bevacizumab will be measured by progression-free survival, objective response rate, time to response, duration of response, and overall survival. This study is also designed to evaluate the safety and tolerability of AMG 655 in combination with mFOLFOX6 and bevacizumab and to evaluate anti-AMG 655 antibody formation and the pharmacokinetics of AMG 655.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum.\n* Subjects with measurable or unmeasurable disease\n* Eastern Cooperative Oncology Group (ECOG) score of 0 or 1\n* Men or women at least 18 years of age\n* Adequate hematologic, renal, hepatic and coagulation function\n\nExclusion Criteria:\n\n* History or known presence of central nervous system (CNS) metastases\n* Prior chemotherapy or other systemic therapy for advanced or metastatic CRC\n* Any investigational agent or therapy for advanced or metastatic CRC\n* Clinically significant cardiac disease\n* Clinically significant peripheral neuropathy\n* Active inflammatory bowel disease\n* Recent gastrointestinal ulcer or hemorrhage\n* Recent arterial thrombotic event or pulmonary embolus\n* Recent history of clinically significant bleeding, bleeding diathesis, or coagulopathy\n* Recent major surgical procedure or not yet recovered from major surgery'}, 'identificationModule': {'nctId': 'NCT00625651', 'briefTitle': 'Phase 1b/2 Study of AMG 655 With mFOLFOX6 and Bevacizumab for First-Line Metastatic Colorectal Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Phase 1b/2 Study of AMG 655 in Combination With Modified FOLFOX6 and Bevacizumab for the First-Line Treatment of Subjects With Metastatic Colorectal Cancer', 'orgStudyIdInfo': {'id': '20060464'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AMG 655 Low Dose', 'description': 'AMG 655 (low dose) + mFOLFOX6 + Bevacizumab', 'interventionNames': ['Drug: AMG 655', 'Drug: Modified FOLFOX6', 'Drug: Bevacizumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo + mFOLFOX6 + Bevacizumab', 'interventionNames': ['Drug: Placebo', 'Drug: Modified FOLFOX6', 'Drug: Bevacizumab']}, {'type': 'EXPERIMENTAL', 'label': 'AMG 655 High Dose', 'description': 'AMG 655 (high dose) + mFOLFOX6 + Bevacizumab', 'interventionNames': ['Drug: AMG 655', 'Drug: Modified FOLFOX6', 'Drug: Bevacizumab']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Inactive dummy AMG 655 (to maintain blind)', 'armGroupLabels': ['Placebo']}, {'name': 'AMG 655', 'type': 'DRUG', 'description': 'AMG 655 is an investigational, fully human monoclonal agonist antibody that selectively binds to Death Receptor-5 (DR5).', 'armGroupLabels': ['AMG 655 High Dose', 'AMG 655 Low Dose']}, {'name': 'Modified FOLFOX6', 'type': 'DRUG', 'otherNames': ['mFOLFOX6'], 'description': 'Combination treatment comprising oxaliplatin (85 mg/m2), leucovorin (400 mg/m2) and bolus 5-FU (400 mg/m2) and continuous IV 5-FU (2400 mg/m2)\\] administered by intravenous infusion once every 14 days (+3 days)', 'armGroupLabels': ['AMG 655 High Dose', 'AMG 655 Low Dose', 'Placebo']}, {'name': 'Bevacizumab', 'type': 'DRUG', 'description': 'Bevacizumab will be administered at a dose of 5 mg/kg by intravenous infusion on day 1 of each 14 day cycle (+3 days).', 'armGroupLabels': ['AMG 655 High Dose', 'AMG 655 Low Dose', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71913', 'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'zip': '90241', 'city': 'Downey', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.94001, 'lon': -118.13257}}, {'zip': '92093-0957', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '92270', 'city': 'Rancho Mirage', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.73974, 'lon': -116.41279}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '19718', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '34741', 'city': 'Kissimmee', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 28.30468, 'lon': -81.41667}}, {'zip': '34788', 'city': 'Leesburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 28.81082, 'lon': -81.87786}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30045', 'city': 'Lawrenceville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.95621, 'lon': -83.98796}}, {'zip': '60426', 'city': 'Harvey', 'state': 'Illinois', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.61003, 'lon': -87.64671}}, {'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'zip': '46227', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '66210', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '21215', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21237', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48106-0995', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '49085', 'city': 'Saint Joseph', 'state': 'Michigan', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.10976, 'lon': -86.48002}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '63136', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '59405', 'city': 'Great Falls', 'state': 'Montana', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 47.50024, 'lon': -111.30081}}, {'zip': '07740', 'city': 'Long Branch', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.30428, 'lon': -73.99236}}, {'zip': '87109-4397', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '12534', 'city': 'Hudson', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.25286, 'lon': -73.79096}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10469', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '28801', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '27215', 'city': 'Burlington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.09569, 'lon': -79.4378}}, {'zip': '28054', 'city': 'Gastonia', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.26208, 'lon': -81.1873}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45226', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43219', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '45042', 'city': 'Middletown', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.51506, 'lon': -84.39828}}, {'zip': '97227', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '17109', 'city': 'Harrisburg', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.2737, 'lon': -76.88442}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '17901', 'city': 'Pottsville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.68565, 'lon': -76.1955}}, {'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '38120', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75080', 'city': 'Richardson', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.94818, 'lon': -96.72972}}, {'zip': '75702', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'zip': '76310', 'city': 'Wichita Falls', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.91371, 'lon': -98.49339}}, {'zip': '84403', 'city': 'Ogden', 'state': 'Utah', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.223, 'lon': -111.97383}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '23235', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': '98684', 'city': 'Vancouver', 'state': 'Washington', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 45.63873, 'lon': -122.66149}}], 'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}