Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-27 @ 4:14 AM
Study NCT ID:
NCT00849550
Status:
COMPLETED
Last Update Posted:
2012-12-24
First Post:
2009-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Dosage Study of RAD001 (Everolimus) in Combination With Current Standard of Care to Treat Advanced Solid Tumors.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069287', 'term': 'Capecitabine'}], 'ancestors': [{'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-21', 'studyFirstSubmitDate': '2009-02-22', 'studyFirstSubmitQcDate': '2009-02-23', 'lastUpdatePostDateStruct': {'date': '2012-12-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the MTD/RPTD of capecitabine/oxaliplatin/bevacizumab/everolimus (XELOX-A-Ev) for subjects with advanced solid tumors.', 'timeFrame': 'End of treatment phase'}], 'secondaryOutcomes': [{'measure': 'Describe dose-limiting and non-dose-limiting toxicities', 'timeFrame': 'End of treatment phase'}, {'measure': 'preliminarily investigate the response rate and PFS', 'timeFrame': 'from response to progression'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Advanced Solid Tumors', 'Cancer', 'Capecitabine', 'XELOX', 'Neoplasms', 'Oxaliplatin', 'Bevacizumab', 'RAD001'], 'conditions': ['Unspecified Adult Solid Tumor, Protocol Specific', 'Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if RAD001 (everolimus) helps improve the standard treatment of XELOX-A (bevacizumab, oxaliplatin, capecitabine) in advanced solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be 18 years or older\n* Must have a performance status of at least 70% (able to carry on most normal activities)\n* Must have life expectancy of at least 3 months\n* Must have adequate organ and marrow function as determined by lab tests\n* Women of child-bearing potential and men must agree to use two forms of contraception\n* Ability and willingness to sign a written informed consent document\n* Histologically confirmed solid tumor malignancy that is metastatic or unresectable\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding and/or lactating women\n* Patients who have received any other investigational agents within 28 days of the first day of study drug\n* Patients with known CNS metastases\n* History of other carcinomas within last 5 years (except non-melanoma skin cancer, in-situ cervical cancer, localized prostate cancer)\n* Inadequately controlled hypertension\n* Significant vascular disease\n* Invasion or encasement of a major artery\n* Evidence of bleeding diathesis or coagulopathy\n* Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to day 1 of study drug\n* Serious illness or medical condition\n* History of myocardial infarction, unstable angina, cardiac or other vascular stenting\n* History of stroke\n* HIV, Hepatitis C, Hepatitis B or other serious chronic infection\n* Impairment of Gastrointestinal function or disease\n* History of interstitial lung disease\n* Patients who have had radiation therapy, hormonal therapy, biologic therapy or chemotherapy for cancer within 28 days of receiving study drug.'}, 'identificationModule': {'nctId': 'NCT00849550', 'acronym': 'COBRA', 'briefTitle': 'Safety and Dosage Study of RAD001 (Everolimus) in Combination With Current Standard of Care to Treat Advanced Solid Tumors.', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'A Phase I Study of Capecitabine, Oxaliplatin, Bevacizumab, and RAD001 (XELOX-A-Ev) for Subjects With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'Pro00015605'}, 'secondaryIdInfos': [{'id': '4265', 'type': 'OTHER', 'domain': 'Legacy IRB number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'XELOX-A-Ev', 'interventionNames': ['Drug: capecitabine/oxaliplatin/bevacizumab/RAD001 (XELOX-A-Ev)']}], 'interventions': [{'name': 'capecitabine/oxaliplatin/bevacizumab/RAD001 (XELOX-A-Ev)', 'type': 'DRUG', 'description': 'bevacizumab IV, capecitabine oral, oxaliplatin IV, RAD001 oral', 'armGroupLabels': ['XELOX-A-Ev']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60426', 'city': 'Harvey', 'state': 'Illinois', 'country': 'United States', 'facility': 'Ingalls Cancer Research Center', 'geoPoint': {'lat': 41.61003, 'lon': -87.64671}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Herbert Hurwitz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herbert Hurwitz', 'class': 'OTHER'}, 'collaborators': [{'name': 'Roche-Genentech', 'class': 'INDUSTRY'}, {'name': 'Novartis', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Herbert Hurwitz', 'investigatorAffiliation': 'Duke University'}}}}