Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT01203618
Status:
WITHDRAWN
Last Update Posted:
2013-11-04
First Post:
2010-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exploratory Study of Farletuzumab to Treat Resectable, Non-functioning Pituitary Adenomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010911', 'term': 'Pituitary Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007029', 'term': 'Hypothalamic Neoplasms'}, {'id': 'D015173', 'term': 'Supratentorial Neoplasms'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C527484', 'term': 'farletuzumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Trial terminated due to focus of primary therapeutic areas.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-11-01', 'studyFirstSubmitDate': '2010-07-28', 'studyFirstSubmitQcDate': '2010-09-15', 'lastUpdatePostDateStruct': {'date': '2013-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of farletuzumab in subjects with resectable, non-functioning pituitary macroadenomas as measured by objective response in the tumor size.', 'timeFrame': 'Every 3 months'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability of farletuzumab in this patient population.', 'timeFrame': 'Weekly for the first 3 months followed by every 2 weeks for 12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Resectable, non-functioning pituitary adenoma', 'Pituitary tumor', 'Pituitary adenoma', 'Pituitary macroadenoma'], 'conditions': ['Resectable, Non-functioning Pituitary Adenoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate whether therapy with farletuzumab is effective and safe in the treatment of resectable, non-functioning pituitary adenomas.', 'detailedDescription': 'Non-functioning pituitary adenomas are the most frequent type of pituitary tumors, defined by the lack of hormonal overproduction from the tumor. Non-functioning macroadenomas are \\> 1 cm in size that can cause progressive visual loss, headaches, and symptoms of pituitary dysfunction (hypopituitarism and/or hyperprolactinemia). Initial treatment for these type of tumors is trans sphenoidal surgical resection. In cases where the outcome is incomplete surgical resection of the tumor, repeat surgery and external beam radiation therapy may be performed. Previous clinical work suggests there may be a role for a folate receptor in the treatment of non-secretory, pituitary adenomas. MORAb-003 is a monoclonal antibody that has the potential to be an effective agent against resectable, non-functioning pituitary adenomas. MORAb-003 has been shown to be well tolerated. This study allows the opportunity to determine if therapy with farletuzumab is effective and safe.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females \\>18 years old\n* Diagnosis of non-functional pituitary adenoma\n* Able and willing to undergo surgical resection of the pituitary tumor\n* Significant medical conditions must be well-controlled and stable for at least 30 days prior to signing the informed consent form\n\nExclusion Criteria:\n\n* Presence of clinically significant pituitary apoplexy\n* Presence of hormone-secreting adenomas\n* Presence of compressive optic neuropathy due to pituitary tumor\n* No prior surgical, medical, or radiation therapy in the last 6 months'}, 'identificationModule': {'nctId': 'NCT01203618', 'briefTitle': 'Exploratory Study of Farletuzumab to Treat Resectable, Non-functioning Pituitary Adenomas', 'organization': {'class': 'INDUSTRY', 'fullName': 'Morphotek'}, 'officialTitle': 'Exploratory Phase 2 Study of Farletuzumab in Resectable Non-functioning Pituitary Adenoma', 'orgStudyIdInfo': {'id': 'MORAb-003-007'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Farletuzumab', 'type': 'DRUG', 'otherNames': ['MORAb-003'], 'description': 'Farletuzumab initial loading dose 5.0 mg/kg intravenous followed by 2.5 mg/kg intravenous for all subsequent doses every 2 weeks for up to 12 months.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Bruce Wallin, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Morphotek'}, {'name': 'Nelson Oyesiku, MD, PhD, FACS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Morphotek', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}