Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-01-07 @ 12:34 AM
Study NCT ID:
NCT00089960
Status:
COMPLETED
Last Update Posted:
2013-04-29
First Post:
2004-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of AMG 706 in Subjects With Advanced Gastrointestinal Stromal Tumors (GISTs)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium', 'Canada', 'France', 'Germany', 'Italy', 'United Kingdom', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000625785', 'term': 'motesanib diphosphate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 138}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': True}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-25', 'studyFirstSubmitDate': '2004-08-18', 'studyFirstSubmitQcDate': '2004-08-19', 'lastUpdatePostDateStruct': {'date': '2013-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate as defined using modified RECIST criteria.', 'timeFrame': '48 weeks treatment or until progressive disease, or unacceptable toxicity'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'time from randomization to progressive disease'}, {'measure': 'Overall survival', 'timeFrame': 'time to death'}, {'measure': 'Time to progression', 'timeFrame': 'time from response to progressive disease'}, {'measure': 'Time to response', 'timeFrame': 'time from first treatment to response'}, {'measure': 'Patient-reported outcomes', 'timeFrame': 'quality of life'}, {'measure': 'Use of opioid analgesics after minimal 6 months treatment', 'timeFrame': 'narcotics usage during study'}, {'measure': 'Objective response by PET and tumor size/density changes at week 8', 'timeFrame': 'response rate at week 8'}, {'measure': 'Objective response by size changes and/or target tumor density changes at week 8', 'timeFrame': 'response rate at week 8'}, {'measure': 'Safety Endpoints: Incidence of adverse events (including all, serious, grade 3, grade 4 and treatment related)', 'timeFrame': 'for duration of study'}, {'measure': 'Duration of response', 'timeFrame': 'time to respone to progression'}, {'measure': 'Palliative response', 'timeFrame': 'amelioration of symptoms'}, {'measure': 'Pharmacokinetic Endpoints: 1. The AMG 706 PK parameters (Cmax, t1/2, AUC0-24, C24); 2. To explore the PK/PD relationships', 'timeFrame': 'during specific study timepoints'}]}, 'conditionsModule': {'keywords': ['GIST'], 'conditions': ['Gastrointestinal Cancer']}, 'referencesModule': {'references': [{'pmid': '20838998', 'type': 'RESULT', 'citation': 'Benjamin RS, Schoffski P, Hartmann JT, Van Oosterom A, Bui BN, Duyster J, Schuetze S, Blay JY, Reichardt P, Rosen LS, Skubitz K, McCoy S, Sun YN, Stepan DE, Baker L. Efficacy and safety of motesanib, an oral inhibitor of VEGF, PDGF, and Kit receptors, in patients with imatinib-resistant gastrointestinal stromal tumors. Cancer Chemother Pharmacol. 2011 Jul;68(1):69-77. doi: 10.1007/s00280-010-1431-9. Epub 2010 Sep 14.'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}, {'url': 'http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf', 'label': 'Notice regarding posted summaries of trial results'}, {'url': 'http://download.veritasmedicine.com/REGFILES/amgen/08D_FDAMA_113_Posting_Summary_63_AMG_706_20040110.pdf', 'label': 'To access clinical trial results information click on this link'}]}, 'descriptionModule': {'briefSummary': 'This study will determine the safety and effectiveness of AMG 706 in patients with advanced GIST.', 'detailedDescription': 'Expanded Access: Amgen provides expanded access for this clinical trial. Contact the Amgen Call Center (866-572-6436) for more information.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Age ≥ 18 years;\n* Disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) during previous treatment with imatinib mesylate at least 600 mg daily for at least 8 weeks, as per two independently assessed prestudy computerized tomography (CT) scans;\n* Presence of at least one measurable (per RECIST)\n* Progressing tumor lesion not previously treated with radiotherapy or embolization and evaluable by CT scan or magnetic resonance imaging (MRI);\n* Karnofsky performance status ≥ 60;\n* imatinib treatment terminated at least 7 days before study day 1;\n* Adequate hepatic, renal, and cardiac function.\n\nExclusion criteria:\n\n* Prior malignancy (other than GIST, in situ cervical cancer, or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for ≥ 3 years; cardiac disease including myocardial infarction, unstable angina, and congestive heart failure (New York Heart Association class \\> II),\n* uncontrolled hypertension (systolic \\> 145 mmHg or diastolic \\> 85 mmHg),\n* History of arterial thrombosis or deep vein thrombosis (including pulmonary embolus) within 1 year of study day 1;\n* Absolute neutrophil count \\< 1.5x109/L, platelet count \\< 100x109/L, hemoglobin \\< 9.0 g/dL;\n* Prior treatment with motesanib diphosphate or other KIT (except imatinib) or VEGF inhibitors.\n* The study was approved by the institutional review board of each participating institution, and all patients provided written informed consent before any study-related procedures were performed.'}, 'identificationModule': {'nctId': 'NCT00089960', 'briefTitle': 'Study of AMG 706 in Subjects With Advanced Gastrointestinal Stromal Tumors (GISTs)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'An Open Label Study of AMG 706 in Subjects With Advanced Gastrointestinal Stromal Tumors (GISTs) Who Developed Progressive Disease or Relapsed While on Imatinib Mesylate', 'orgStudyIdInfo': {'id': '20040110'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Arm', 'description': 'AMG 125 mg daily continuously', 'interventionNames': ['Drug: AMG 706']}], 'interventions': [{'name': 'AMG 706', 'type': 'DRUG', 'description': 'AMG 706 125 mg daily for 48 weeks, or until progressive disease or unacceptable toxicity.', 'armGroupLabels': ['Arm']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}