Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
Study NCT ID:
NCT00455351
Status:
COMPLETED
Last Update Posted:
2023-05-08
First Post:
2007-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vorinostat and Palliative Radiotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010386', 'term': 'Pelvic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077337', 'term': 'Vorinostat'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D006877', 'term': 'Hydroxamic Acids'}, {'id': 'D006898', 'term': 'Hydroxylamines'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-05', 'studyFirstSubmitDate': '2007-04-02', 'studyFirstSubmitQcDate': '2007-04-02', 'lastUpdatePostDateStruct': {'date': '2023-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-04-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DLT', 'timeFrame': 'continously'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Palliative treatment', 'Max. tolerable dose'], 'conditions': ['Pelvic Cancer', 'Radiotherapy']}, 'referencesModule': {'references': [{'pmid': '20378407', 'type': 'RESULT', 'citation': 'Ree AH, Dueland S, Folkvord S, Hole KH, Seierstad T, Johansen M, Abrahamsen TW, Flatmark K. Vorinostat, a histone deacetylase inhibitor, combined with pelvic palliative radiotherapy for gastrointestinal carcinoma: the Pelvic Radiation and Vorinostat (PRAVO) phase 1 study. Lancet Oncol. 2010 May;11(5):459-64. doi: 10.1016/S1470-2045(10)70058-9. Epub 2010 Apr 6.'}, {'pmid': '21473790', 'type': 'DERIVED', 'citation': 'Bratland A, Dueland S, Hollywood D, Flatmark K, Ree AH. Gastrointestinal toxicity of vorinostat: reanalysis of phase 1 study results with emphasis on dose-volume effects of pelvic radiotherapy. Radiat Oncol. 2011 Apr 8;6:33. doi: 10.1186/1748-717X-6-33.'}]}, 'descriptionModule': {'briefSummary': 'Phase I study. Side-effects when combined with standard palliative radiotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pelvic malignancy\n* Palliative radiation treatment planed\n* ECOG \\<3\n* Age\\>18 years\n\nExclusion Criteria:\n\n* Previous pelvic radiotherapy\n* Uncontrolled diarrhea\n* Insulin-dependent diabetes mellitus\n* BMI\\<18.5'}, 'identificationModule': {'nctId': 'NCT00455351', 'acronym': 'PRAVO', 'briefTitle': 'Vorinostat and Palliative Radiotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Phase I Study on Suberoylanilide Hydroxyamic Acid (Vorinostat) a Histone Deacetylase Inhibitor, in Palliative Radiotherapy for Advanced Tumors.', 'orgStudyIdInfo': {'id': 'EudraCTnumber 2006-003631-76'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A I', 'description': 'Study drug', 'interventionNames': ['Drug: Vorinostat']}], 'interventions': [{'name': 'Vorinostat', 'type': 'DRUG', 'description': 'Increasing dosing, phase I', 'armGroupLabels': ['A I']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NO-0310', 'city': 'Oslo', 'country': 'Norway', 'facility': 'The Norwegian Radium Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Sigbjørn Smeland, MD,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Norwegian Radium Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior physician', 'investigatorFullName': 'Svein Dueland', 'investigatorAffiliation': 'Oslo University Hospital'}}}}