Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 12:35 AM
Study NCT ID:
NCT00199160
Status:
COMPLETED
Last Update Posted:
2015-05-20
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Activity of BAY 43-9006 in Patients With Recurrent and/or Metastatic Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077157', 'term': 'Sorafenib'}], 'ancestors': [{'id': 'D010671', 'term': 'Phenylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009536', 'term': 'Niacinamide'}, {'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-09', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-19', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2015-05-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFS'}]}, 'conditionsModule': {'keywords': ['local recurrence and or metastatic disease', 'Previously treated with platinum', 'carcinoma of the head and neck'], 'conditions': ['Head and Neck Neoplasms']}, 'descriptionModule': {'briefSummary': 'This is a Phase II trial evaluating the efficacy and the biological activity of BAY 43-9006 in patients with recurrent and/or metastatic head and neck cancer.', 'detailedDescription': 'This is a Phase II trial evaluating the efficacy and the biological activity of BAY 43-9006 in patients with recurrent and/or metastatic head and neck cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and female patients (18 years old and above), with a histologically proven, measurable, locally recurrent, and/or metastatic head and neck tumor.\n* \\> 4 weeks since major surgery\n* \\> 4 weeks since prior chemotherapy\n* \\> 3 weeks since prior therapy with biological agents (Interleukin-2 \\[IL-2\\], interferon, other molecular-targeted therapies \\[except Ras/Raf inhibitors\\]).\n* Performance status \\< 2\n* Life expectancy \\> 3 months.\n* At least one uni-dimensional measurable lesion by computed tomography (CT)-scan or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST)\n* Adequate liver, pancreatic, renal, and coagulation function\n* A slide or paraffin-block from a tumor biopsy MUST be available at the time of screening. If the original diagnostic biopsy is not available at the time of screening, an additional biopsy is required.\n\nExclusion Criteria:\n\n* Severe preexisting conditions\n* Evidence of bone marrow suppression\n* Frequent vomiting or medical condition, which could interfere with oral medication intake\n* Lack of resolution of all toxic manifestations of prior chemotherapy, biologic, or radiation therapy (alopecia excluded).\n* Known HIV positivity or AIDS-related illness.\n* Previous exposure to a Ras/Raf inhibitor\n* Previous malignancy (except for cervical carcinoma in situ, adequately treated basal cell carcinoma, or superficial bladder tumors \\[Ta, Tis and T1\\] or other malignancies curatively treated \\> 2 years prior to entry)\n* Congestive heart failure\n* Cardiac arrhythmias requiring anti-arrhythmics\n* Active coronary artery disease or ischaemia\n* Active clinically serious bacterial or fungal infections\n* Known brain or meningeal metastases\n* Patients with seizure disorder requiring medication (such as anti-epileptics)\n* Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results\n* Known or suspected allergy to the investigational agent or any agent given in association with this trial\n* Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test.\n* Concurrent anti-cancer chemotherapy or immunotherapy is excluded\n* Significant surgery within four weeks prior to start of study drug\n* Investigational drug therapy outside of this trial, or any chemotherapy during or within 4 weeks prior to start of study drug\n* Myelosuppressive radiotherapy within four weeks prior to start of study drug (short-course non-myelosuppressive radiotherapy may be allowed based on approval of principal investigators)\n* Concomitant treatment with ketoconazole, itraconazole, ritonavir, or use of grapefruit juice"}, 'identificationModule': {'nctId': 'NCT00199160', 'briefTitle': 'Efficacy and Activity of BAY 43-9006 in Patients With Recurrent and/or Metastatic Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Jules Bordet Institute'}, 'orgStudyIdInfo': {'id': 'BAY 43-9006 Head and Neck'}}, 'armsInterventionsModule': {'interventions': [{'name': 'BAY 43-9006', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Jules Bordet Institute', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'AHMAD AWADA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jules Bordet Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jules Bordet Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}