Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-25 @ 2:45 PM
Study NCT ID:
NCT00073450
Status:
TERMINATED
Last Update Posted:
2015-04-21
First Post:
2003-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck (Study P02530)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C436083', 'term': '2-(2-oxo-2-((3,7,11-trimethyl-2,6,10-dodecatrienyl)oxy)aminoethyl)phosphonic acid, (2,2-dimethyl-1-oxopropoxy)methyl ester sodium'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2003-09'}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2004-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-20', 'studyFirstSubmitDate': '2003-11-20', 'studyFirstSubmitQcDate': '2003-11-21', 'lastUpdatePostDateStruct': {'date': '2015-04-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-06', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Squamous Cell Carcinoma of the Head & Neck'], 'conditions': ['Carcinoma, Squamous Cell', 'Head and Neck Neoplasms']}, 'referencesModule': {'references': [{'pmid': '19433965', 'type': 'RESULT', 'citation': 'Hanrahan EO, Kies MS, Glisson BS, Khuri FR, Feng L, Tran HT, Ginsberg LE, Truong MT, Hong WK, Kim ES. A phase II study of Lonafarnib (SCH66336) in patients with chemorefractory, advanced squamous cell carcinoma of the head and neck. Am J Clin Oncol. 2009 Jun;32(3):274-9. doi: 10.1097/COC.0b013e318187dd57.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and efficacy of an oral Farnesyl Protein Transferase Inhibitor (Lonafarnib/SCH 6636) as a single agent in Adult Patients With Squamous Cell Carcinoma of the Head \\& Neck and will help determine if further development is justified.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically proven squamous cell carcinoma of the head \\& neck.\n* Age greater than or equal to 18.\n* ECOG performance status of 0 to 1\n* Measurable malignant disease.\n* Patients that have failed at least one platinum-containing regimen and have received no more than three prior regimens and do not have other curative treatment options.\n* Patients must be at least 2 wks post surgery or radiation therapy\n* Patients must be at least 4 weeks post chemotherapy\n* Meets protocol requirements for specified laboratory values.\n* Written informed consent and cooperation of patient.\n* Appropriate use of effective contraception if of childbearing potential.\n* No investigational drugs of any type within 30 days prior to administration.\n\nExclusion Criteria:\n\n* Prior exposure to farnesyl transferase inhibitors\n* Medical conditions that would interfere with taking oral medications.\n* Patients with significant QTc prolongation at baseline (\\>500 msec.)\n* Pregnant or nursing women\n* Known HIV positivity or AIDS-related illness.\n* Concomitant chemotherapy, hormonal therapy, radiotherapy or immunotherapy\n* Patients with any signs of involvement of the dura, meninges, or brain.\n* Patients with squamous cell carcinoma of the nasopharynx\n* Patients who currently have other cancers or have been treated in the last 5 years for any other malignancy.'}, 'identificationModule': {'nctId': 'NCT00073450', 'briefTitle': 'Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck (Study P02530)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'An Open-Label Phase 2 Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck', 'orgStudyIdInfo': {'id': 'P02530'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Farnesyl Protein Transferase Inhibitor', 'type': 'DRUG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}