Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
Study NCT ID:
NCT00328458
Status:
COMPLETED
Last Update Posted:
2025-05-02
First Post:
2006-05-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EPO906 Plus Radiation Therapy for the Treatment of Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C093788', 'term': 'epothilone B'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-01', 'studyFirstSubmitDate': '2006-05-19', 'studyFirstSubmitQcDate': '2006-05-19', 'lastUpdatePostDateStruct': {'date': '2025-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-05-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose (MTD) of EPO906', 'timeFrame': 'Baseline to 7 weeks'}], 'secondaryOutcomes': [{'measure': 'Number of participants that successful complete 7 weekly cycles of EPO906 concurrently with radiotherapy', 'timeFrame': 'Baseline to 7 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CNS and head and neck cancers', 'Histologically confirmed CNS malignancy head and neck', 'there is on standard therapy or', 'have failed standard therapy'], 'conditions': ['Central Nervous System Neoplasms', 'Head and Neck Neoplasms']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.KimmelCancerCenter.org', 'label': 'Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety of the drug EPO906 that could shrink tumors when used with radiation therapy in cancer patients.', 'detailedDescription': '* To determine the maximum tolerated dose (MTD) of EPO906 administered in combination with radiation therapy and establish a recommend phase II dose.\n* To evaluate the safety and toxicity profile of EPO906 when administered concurrently with radiotherapy in three disease cohorts.\n* To evaluate tumor response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Requires a minimum of 3 weeks of radiation therapy\n* Solid tumors with advanced or recurrent disease for which there is no standard therapy or tumors have failed standard therapy\n* World Health Organization (WHO) performance status equal to or less than 2\n* Life expectancy equal to or greater than 3 months\n\nExclusion Criteria:\n\n* Any peripheral neuropathy\n* Unresolved diarrhea greater than grade 1\n* Patients who received any other investigational compound within the past 28 days\n* Severe cardiac insufficiency\n* Patients on Coumadin'}, 'identificationModule': {'nctId': 'NCT00328458', 'briefTitle': 'EPO906 Plus Radiation Therapy for the Treatment of Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'A Phase I, Open-label, Dose-escalation, Safety Study of the Combination of EPO906 and Radiation Therapy for the Treatment of Patients With Cancer', 'orgStudyIdInfo': {'id': '03C.275'}, 'secondaryIdInfos': [{'id': '2003-33', 'type': 'OTHER', 'domain': 'CCRRC'}, {'id': 'JT 1035', 'type': 'OTHER', 'domain': 'JeffTrial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1 Brain Tumors', 'description': 'The investigational drug - EPO906 will be administered as an intravenous infusion over five to ten minutes on weeks 1, 3 and 6, for the duration of radiation therapy up to a maximum of 7 weeks. Duration of therapy will be determined by disease cohort.', 'interventionNames': ['Drug: EPO906 (epothilone B)']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2 Head and Neck Tumors', 'description': 'The investigational drug - EPO906 will be administered as an intravenous infusion over five to ten minutes on weeks 1, 3 and 6, for the duration of radiation therapy up to a maximum of 7 weeks. Duration of therapy will be determined by disease cohort.', 'interventionNames': ['Drug: EPO906 (epothilone B)']}], 'interventions': [{'name': 'EPO906 (epothilone B)', 'type': 'DRUG', 'armGroupLabels': ['Cohort 1 Brain Tumors', 'Cohort 2 Head and Neck Tumors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Adam Dicker, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thomas Jefferson University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sidney Kimmel Cancer Center at Thomas Jefferson University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}