Viewing Study NCT00423150

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Ignite Creation Date: 2025-12-24 @ 5:05 PM
Ignite Modification Date: 2026-03-08 @ 11:20 PM
Study NCT ID: NCT00423150
Status: TERMINATED
Last Update Posted: 2017-06-08
First Post: 2006-11-30
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Phase 2 Study of Temozolomide in Pre-Selected Advanced Aerodigestive Tract Cancers (Study P04273AM2)(TERMINATED)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Brazil', 'Canada', 'Czechia', 'Greece', 'Honduras', 'Italy', 'Mexico', 'Netherlands', 'Peru', 'Portugal', 'Puerto Rico', 'Spain', 'Sweden', 'Switzerland', 'United Kingdom', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D004938', 'term': 'Esophageal 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'}, {'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': 'D004935', 'term': 'Esophageal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077204', 'term': 'Temozolomide'}], 'ancestors': [{'id': 'D003606', 'term': 'Dacarbazine'}, {'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The investigator agrees not to publish or publicly present any interim results\n\nof the study without the prior written consent of the sponsor. The investigator further agrees to provide to the sponsor, 45 days prior to submission, review copies of abstracts or manuscripts for publication that report any results of the study. If the parties disagree, investigator agrees to meet with the sponsor, prior to submission, for the purpose of making good faith efforts to discuss/resolve any such issues.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Due to low response rate for colorectal cancer in interim analyses, low enrollment in head \\& neck and non-small cell lung cancer groups due to low methylation rates, and low overall response rate in esophageal cancer group, the study was terminated.'}}, 'adverseEventsModule': {'description': 'Other adverse events: these non-serious events are treatment-emergent.', 'eventGroups': [{'id': 'EG000', 'title': 'Temozolomide', 'description': 'Temozolomide capsules 150 mg/m\\^2 daily on a 7-day on/7-day off schedule for each 28-day cycle. Temozolomide is the only treatment group, and and all participants received the same dosing regimen.', 'otherNumAtRisk': 86, 'otherNumAffected': 83, 'seriousNumAtRisk': 86, 'seriousNumAffected': 37}], 'otherEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 30, 'numAffected': 17}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'LYMPHOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 18, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'THROMBOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 55, 'numAffected': 19}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 13, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 25, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 37, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'GASTROOESOPHAGEAL REFLUX DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 84, 'numAffected': 45}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 53, 'numAffected': 35}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 75, 'numAffected': 36}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'OEDEMA PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 13, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'LOWER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'PLATELET COUNT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 9, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'WEIGHT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'ANOREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 33, 'numAffected': 31}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'HYPERGLYCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 11, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'MUSCULOSKELETAL CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 9, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'MUSCULOSKELETAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 16, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 27, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'NEUROPATHY PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'ANXIETY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 17, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'seriousEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'FEBRILE NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'LEUKOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'THROMBOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'ACUTE MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'ATRIAL FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'CARDIO-RESPIRATORY ARREST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'VERTIGO', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'DYSPHAGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'GASTROINTESTINAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'MELAENA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'UPPER GASTROINTESTINAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'MULTI-ORGAN FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'BILE DUCT OBSTRUCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'HYPERBILIRUBINAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'BACTERAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'ACCIDENTAL OVERDOSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'ACETABULUM FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'BLOOD CREATININE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'BLOOD UREA INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'OXYGEN CONSUMPTION INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'ANOREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'DEHYDRATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'HYPERCALCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'HYPERGLYCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'HYPOKALAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'HYPONATRAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'PATHOLOGICAL FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'CEREBRAL ARTERY THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'CONVULSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'HEPATIC ENCEPHALOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'HYPOAESTHESIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'SPINAL CORD COMPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'CONFUSIONAL STATE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'HAEMATURIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'RENAL FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'RENAL FAILURE ACUTE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'ACUTE PULMONARY OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'DYSPNOEA EXERTIONAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'HAEMOPTYSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'HYPOXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'INCREASED UPPER AIRWAY SECRETION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'PLEURAL EFFUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'PULMONARY OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'RESPIRATORY ACIDOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'RESPIRATORY FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'NEPHROSTOMY TUBE REMOVAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Tumor Responses (Complete and Partial Response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Temozolomide', 'description': 'Temozolomide capsules 150 mg/m\\^2 daily on a 7-day on/7-day off schedule for each 28-day cycle. Temozolomide is the only treatment group, and and all participants received the same dosing regimen.'}], 'classes': [{'title': 'Number of participants with Complete Response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Number of participants with Partial Response', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From start of treatment until participant's disease progression, intolerable toxicity or death, which ever comes first", 'description': 'Tumor response rate was based on Response Evaluation Criteria in Solid Tumors (RECIST).\n\nComplete Response (CR): Disappearance of all target lesions.\n\nPartial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population for the primary outcome measure is all evaluable participants per protocol definition (82 participants).\n\nComplete response is defined as disappearance of all target lesions.\n\nPartial response is defined as at least 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Temozolomide', 'description': 'Temozolomide capsules 150 mg/m\\^2 daily on a 7-day on/7-day off schedule for each 28-day cycle. Temozolomide is the only treatment group, and and all participants received the same dosing regimen.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'Progression of disease being studied', 'reasons': [{'groupId': 'FG000', 'numSubjects': '69'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Non-compliance with protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Administrative', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Temozolomide', 'description': 'Temozolomide capsules 150 mg/m\\^2 daily on a 7-day on/7-day off schedule for each 28-day cycle. Temozolomide is the only treatment group, and and all participants received the same dosing regimen.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.9', 'spread': '10.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '57', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-01-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2009-06-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-12', 'studyFirstSubmitDate': '2006-11-30', 'resultsFirstSubmitDate': '2010-05-27', 'studyFirstSubmitQcDate': '2007-01-17', 'lastUpdatePostDateStruct': {'date': '2017-06-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-05-27', 'studyFirstPostDateStruct': {'date': '2007-01-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-07-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor Responses (Complete and Partial Response)', 'timeFrame': "From start of treatment until participant's disease progression, intolerable toxicity or death, which ever comes first", 'description': 'Tumor response rate was based on Response Evaluation Criteria in Solid Tumors (RECIST).\n\nComplete Response (CR): Disappearance of all target lesions.\n\nPartial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Colorectal Neoplasm', 'Head and Neck Neoplasm', 'Carcinoma, Non-Small-Cell Lung', 'Esophageal Neoplasm']}, 'referencesModule': {'references': [{'pmid': '23443801', 'type': 'RESULT', 'citation': 'Hochhauser D, Glynne-Jones R, Potter V, Gravalos C, Doyle TJ, Pathiraja K, Zhang Q, Zhang L, Sausville EA. A phase II study of temozolomide in patients with advanced aerodigestive tract and colorectal cancers and methylation of the O6-methylguanine-DNA methyltransferase promoter. Mol Cancer Ther. 2013 May;12(5):809-18. doi: 10.1158/1535-7163.MCT-12-0710. Epub 2013 Feb 26.'}]}, 'descriptionModule': {'briefSummary': 'This study is proposed to evaluate the efficacy and safety of temozolomide, an oral anti-cancer agent, in a participant population selected for a biomarker. Participants with colorectal cancer, non-small-cell lung cancer, head and neck cancer, or esophageal cancer will be included.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must be at least 18 years of age.\n* Participants must have metastatic colorectal cancer (CRC), recurrent or metastatic head \\& neck (H\\&N) or esophageal cancer, or locally advanced, inoperable, or metastatic non-small cell lung cancer (NSCLC).\n* Participants must have a tumor sample or a blood sample tested positive for the presence of the biomarker.\n* Participants may have up to 3 prior regimens for CRC, up to 3 prior regimens for NSCLC, up to 2 prior regimens for H\\&N and esophageal cancer.\n* Participants must have at least one measurable lesion.\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.\n* Participants must have adequate hematologic, renal, and liver functions.\n* Participants must be able to take the study medication capsules orally, or through a feeding tube without the capsules being opened.\n* Participants of childbearing potential must agree to use a medically accepted method of contraception.\n\nExclusion Criteria:\n\n* Participants who have received treatment for a second malignancy within 1 year before screening, and are considered to be at risk of relapse within 1 year after screening.\n* Participants with unstable or progressing central nervous system (CNS) metastasis. Participants with known CNS metastasis may be included if a) the subject is asymptomatic, b) there is no requirement for steroids or antiseizure medications, or the required doses are stable, and c) there is no associated midline shift or (in the opinion of the investigator) significant edema.\n* Participants who received prior temozolomide or dacarbazine treatment'}, 'identificationModule': {'nctId': 'NCT00423150', 'briefTitle': 'Phase 2 Study of Temozolomide in Pre-Selected Advanced Aerodigestive Tract Cancers (Study P04273AM2)(TERMINATED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase 2 Study of Temozolomide (SCH 52365) in Subjects With Advanced Aerodigestive Tract Cancers Selected for Methylation of O6-Methyl-Guanine-DNA Methyltransferase (MGMT) Promoter', 'orgStudyIdInfo': {'id': 'P04273'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Temozolomide', 'interventionNames': ['Drug: Temozolomide']}], 'interventions': [{'name': 'Temozolomide', 'type': 'DRUG', 'otherNames': ['Temodal, TMZ, SCH 52365'], 'description': 'Temozolomide capsules 150 mg/m\\^2 daily on a 7-day on / 7-day off schedule for each 28-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent.', 'armGroupLabels': ['Temozolomide']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\\_Updated%20July\\_9\\_2014.pdf\n\nhttp://engagezone.msd.com/ds\\_documentation.php'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}