Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-28 @ 12:07 AM
Study NCT ID:
NCT00888134
Status:
COMPLETED
Last Update Posted:
2016-01-15
First Post:
2009-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Selumetinib in Cancers With BRAF Mutations
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C517975', 'term': 'AZD 6244'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dplawrence@mgh.harvard.edu', 'phone': '617-643-3614', 'title': 'Donald P. Lawrence', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)', 'description': 'Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment (Selumetinib)', 'description': 'Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nSelumetinib: Given PO', 'otherNumAtRisk': 28, 'otherNumAffected': 28, 'seriousNumAtRisk': 28, 'seriousNumAffected': 17}], 'otherEvents': [{'term': 'allergic rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'hemoglobin - low', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 19}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'leukocytes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'platelets', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'INR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'PTT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'fever (without neutropenia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'nail changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'rash/desquamation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'rash: acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 19}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'rash: erythema multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'skin - other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'taste disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'hemorrhage - anus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'hemorrhage - nose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'edema - head and neck', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'edema - limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 14}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'edema - trunk', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 16}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'alkaline phosphatase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 17}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'SGPT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'SGOT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 21}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'bicarbonate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'bilirubin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'hypercholesterolemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'creatinine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 20}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'hypermagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'hypomagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'neuropathy - sensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'tearing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'extremity - limb pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'joint pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'voice changes/ dysarthria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'other', 'notes': 'AEs not falling into pre-defined CTCAE categories', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'other', 'notes': 'AEs not falling into CTCAE categories', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'other', 'notes': 'AEs not falling into CTCAE categories', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'other', 'notes': 'AEs not falling into CTCAE categories', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'other', 'notes': 'AEs not falling into CTCAE categories', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}], 'seriousEvents': [{'term': 'hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'SGPT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'Fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'pulmonary / URT infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'malignant ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'SGOT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'fatal progressive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'increased intraocular pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'blurry vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'joint pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'muscle pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE V 3.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Objective Response Rate in Patients With Cancers Other Than Melanoma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Selumetinib)', 'description': 'Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nSelumetinib: Given PO'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 years', 'description': 'Percentage of participants achieving either complete response (disappearance of all target lesions) or partial response (at least a 30% decrease in the sum of the longest diameter of target lesions, when compared with baseline) using CT (computed tomography) scans (which are done every 6 weeks).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'AKT Pathway Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Selumetinib)', 'description': 'Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nSelumetinib: Given PO'}], 'timeFrame': 'Up to 4 years', 'description': 'Correlation between response to AZD6244 and mutational analysis of AKT pathway (an intracellular signaling pathway important in regulating the cell cycle)', 'reportingStatus': 'POSTED', 'populationDescription': 'Samples and data were not collected for this outcome.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate in Patients With Non-small Cell Lung Cancers and Colon Cancers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Selumetinib)', 'description': 'Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nSelumetinib: Given PO'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4 years', 'description': 'Percentage of participants with either colon cancer or non-small cell lung cancer achieving either complete response (disappearance of all target lesions) or partial response (at least a 30% decrease in the sum of the longest diameter of target lesions, when compared with baseline) using CT (computed tomography) scans.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Selumetinib)', 'description': 'Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.\n\nSelumetinib: Given PO'}], 'classes': [{'categories': [{'measurements': [{'value': '21.4', 'groupId': 'OG000', 'lowerLimit': '8.7', 'upperLimit': '37.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 months', 'description': 'Reported as percentage of participants alive and progression free at 4-months. Will be estimated using Kaplan-Meier survival curves. Confidence intervals will be calculated and reported.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sensitivity and Specificity of Detection of the BRAF V600E Mutation in CTC Using the CTC-chip', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Selumetinib)', 'description': 'Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nSelumetinib: Given PO'}], 'timeFrame': 'Up to 4 years', 'reportingStatus': 'POSTED', 'populationDescription': 'Samples and data were not collected for this outcome.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment (Selumetinib)', 'description': 'Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nSelumetinib: Given PO'}], 'periods': [{'title': 'Treatment With Study Drug', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '21 had progressive disease; 5 had unacceptable toxicity; 1 finished treatment', 'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': 'Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '23 died; 3 were lost-to-follow-up', 'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'being followed for long-term survival', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': "Participants 'complete' the treatment period if they ended their treatment for disease progression, unacceptable toxicity, withdrawal of consent, or intercurrent illness. Those participants who completed treatment then enter a follow-up period when they are followed until death or lost-to-follow-up."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment (Selumetinib)', 'description': 'Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nSelumetinib: Given PO'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Type of cancer', 'classes': [{'title': 'Non small-cell lung cancer', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'Colon cancer', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'Other cancer', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-10', 'studyFirstSubmitDate': '2009-04-23', 'resultsFirstSubmitDate': '2015-12-10', 'studyFirstSubmitQcDate': '2009-04-23', 'lastUpdatePostDateStruct': {'date': '2016-01-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-12-10', 'studyFirstPostDateStruct': {'date': '2009-04-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate in Patients With Cancers Other Than Melanoma', 'timeFrame': '4 years', 'description': 'Percentage of participants achieving either complete response (disappearance of all target lesions) or partial response (at least a 30% decrease in the sum of the longest diameter of target lesions, when compared with baseline) using CT (computed tomography) scans (which are done every 6 weeks).'}], 'secondaryOutcomes': [{'measure': 'AKT Pathway Activity', 'timeFrame': 'Up to 4 years', 'description': 'Correlation between response to AZD6244 and mutational analysis of AKT pathway (an intracellular signaling pathway important in regulating the cell cycle)'}, {'measure': 'Objective Response Rate in Patients With Non-small Cell Lung Cancers and Colon Cancers', 'timeFrame': 'Up to 4 years', 'description': 'Percentage of participants with either colon cancer or non-small cell lung cancer achieving either complete response (disappearance of all target lesions) or partial response (at least a 30% decrease in the sum of the longest diameter of target lesions, when compared with baseline) using CT (computed tomography) scans.'}, {'measure': 'Progression-free Survival', 'timeFrame': '4 months', 'description': 'Reported as percentage of participants alive and progression free at 4-months. Will be estimated using Kaplan-Meier survival curves. Confidence intervals will be calculated and reported.'}, {'measure': 'Sensitivity and Specificity of Detection of the BRAF V600E Mutation in CTC Using the CTC-chip', 'timeFrame': 'Up to 4 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Adult Solid Neoplasm']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to determine if selumetinib is safe and effective in treating patients with cancers with a mutated BRAF gene. Selumetinib is an investigational drug that works by blocking a protein called MEK, which is known to play a role in the growth of cancer cells lines and tumors that have a mutated BRAF gene. There are multiple types of cancers that have mutations in the BRAF gene and depend on the activity of this gene for their growth and survival.', 'detailedDescription': "PRIMARY OBJECTIVES:\n\nI. To evaluate the objective response rate to AZD6244 (selumetinib) in patients with cancers other than melanoma in which BRAF mutations have been identified prospectively.\n\nSECONDARY OBJECTIVES:\n\nI. To evaluate progression-free survival in subjects treated with AZD6244. II. To obtain a preliminary estimate of the objective response rate in non-small cell lung cancers and colon cancers with BRAF mutations.\n\nIII. To explore biologic correlates of responsiveness to AZD6244, and specifically to correlate AKT pathway activity with sensitivity to MEK inhibition in the BRAF mutant class of tumors.\n\nIV. To estimate the sensitivity and specificity of detection of the BRAF V600E mutation in circulating tumor cells (CTC) using a microfluidic platform (the 'CTC-chip').\n\nOUTLINE:\n\nPatients receive selumetinib orally (PO) twice daily (BID) for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to understand and willingness to sign a written informed consent document\n* Histologically confirmed metastatic or unresectable solid tumor\n* Results from tumor tissue analysis that show a glutamic acid-for-valine substitution at amino acid position 600 in the BRAF gene (V600E) or other activating BRAF mutation, as determined by high-throughput genotyping\n* Patients may have received any number of prior systemic treatments for their cancer\n* At least one measurable site of disease by CT, according to standard RECIST criteria 1.0\n* ECOG performance status 0-1\n* Absolute neutrophil count \\> 1500 per cubic mm\n* Platelet count \\> 100,000 per cubic mm\n* Hemoglobin \\> 9 g/dl\n* Serum bilirubin \\< 1.5 x upper limit of normal\n* Serum AST and ALT \\< 2.5 x upper limit of normal (=\\< 5 x upper limit of normal, for liver metastases)\n* Serum creatinine \\< 1.5 x upper limit of normal\n* For women of childbearing potential, negative serum pregnancy test and use of physician-approved method of birth control throughout the study\n\nExclusion Criteria:\n\n* Estimated life expectancy \\> 12 weeks\n* Patients with melanoma\n* Have received chemotherapy or radiotherapy within 4 weeks prior to entering the study (6 weeks for nitrosoureas or mitomycin C), or a targeted therapy within 2 weeks prior to entering the study\n* Have not recovered from adverse events due to agents previously administered (CTCAE v3 grade 1 or baseline)\n* Currently receiving other investigational agents\n* Known brain metastases, unless treated and stable off of corticosteroids for at least four weeks\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD6244\n* Prior treatment with a selective inhibitor of RAF or MEK (e.g., RAF265); (note: prior sorafenib is allowed)\n* Uncontrolled intercurrent illness, including but not limited to:\n\n * Clinically significant active infection\n * Symptomatic congestive heart failure, unstable angina pectoris, and/or cardiac arrhythmia other than atrial fibrillation\n * Psychiatric illness/social situations that would limit compliance with study requirements\n* Refractory nausea or vomiting, swallowing disorder, or malabsorption syndrome that would interfere with swallowing or absorbing the study medication\n* Pregnant and/or breast-feeding women\n* Previous or concurrent malignancy, except for the following circumstances:\n\n * Disease-free for at least three years and deemed by investigator to be at low risk for recurrence of that malignancy\n * Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin)\n* History of solid organ transplantation or other condition requiring the use of immunosuppressive medications\n* Uncontrolled hypertension (systolic BP \\>= 150 or diastolic BP \\>= 100 that cannot be controlled with medications)\n* A mean left ventricular ejection fraction (LVEF) less than 45%'}, 'identificationModule': {'nctId': 'NCT00888134', 'briefTitle': 'Selumetinib in Cancers With BRAF Mutations', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Phase II Clinical Trial of the MEK 1/2 Inhibitor AZD6244 in Cancers With BRAF Mutations Identified by Prospective Genotypic Analysis', 'orgStudyIdInfo': {'id': 'NCI-2013-00576'}, 'secondaryIdInfos': [{'id': 'NCI-2013-00576', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'P30CA006516', 'link': 'https://reporter.nih.gov/quickSearch/P30CA006516', 'type': 'NIH'}, {'id': 'U01CA062490', 'link': 'https://reporter.nih.gov/quickSearch/U01CA062490', 'type': 'NIH'}, {'id': 'CDR642346'}, {'id': 'N01CM62206', 'link': 'https://reporter.nih.gov/quickSearch/N01CM62206', 'type': 'NIH'}, {'id': '09-005', 'type': 'OTHER', 'domain': 'Massachusetts General Hospital Cancer Center'}, {'id': '8281', 'type': 'OTHER', 'domain': 'CTEP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (selumetinib)', 'description': 'Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Selumetinib']}], 'interventions': [{'name': 'Selumetinib', 'type': 'DRUG', 'otherNames': ['ARRY-142886', 'AZD6244', 'MEK Inhibitor AZD6244'], 'description': 'Given PO', 'armGroupLabels': ['Treatment (selumetinib)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital Cancer Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02129', 'city': 'Charlestown', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.37787, 'lon': -71.062}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Donald Lawrence', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}