Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-03-01 @ 6:01 AM
Study NCT ID:
NCT02934256
Status:
COMPLETED
Last Update Posted:
2021-09-09
First Post:
2016-10-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Icotinib Study for Patients With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009464', 'term': 'Neuroma, Acoustic'}, {'id': 'D016518', 'term': 'Neurofibromatosis 2'}], 'ancestors': [{'id': 'D009442', 'term': 'Neurilemmoma'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009463', 'term': 'Neuroma'}, {'id': 'D018317', 'term': 'Nerve Sheath Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D003390', 'term': 'Cranial Nerve Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D010524', 'term': 'Peripheral Nervous System Neoplasms'}, {'id': 'D000160', 'term': 'Vestibulocochlear Nerve Diseases'}, {'id': 'D012181', 'term': 'Retrocochlear Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D017253', 'term': 'Neurofibromatoses'}, {'id': 'D009455', 'term': 'Neurofibroma'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D020752', 'term': 'Neurocutaneous Syndromes'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C531470', 'term': 'icotinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-08', 'studyFirstSubmitDate': '2016-10-13', 'studyFirstSubmitQcDate': '2016-10-13', 'lastUpdatePostDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from baseline in QOL(quality of life) score after every course of the treatment', 'timeFrame': 'Baseline,Month 3,Month 6,Month 9,Month 12', 'description': "Patients' QOL(quality of life) would be evaluated after every course of the treatment."}], 'primaryOutcomes': [{'measure': 'Change from Baseline in volume of tumour after every course of the treatment', 'timeFrame': 'Baseline,Month 3,Month 6,Month 9,Month 12', 'description': 'Patients in this clinical trial would receive MRI test to evaluate the volume of tumour after every course of the treatment.'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in hearing ability after every course of the treatment', 'timeFrame': 'Baseline,Month 3,Month 6,Month 9,Month 12', 'description': "Patients' hearing ability would be tested after every course of the treatment."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Neurofibromatosis Type 2', 'Vestibular Schwannoma', 'Other NF2-related tumors'], 'conditions': ['Vestibular Schwannoma', 'Neurofibromatosis Type 2']}, 'descriptionModule': {'briefSummary': "1)Preliminarily evaluate the treatment effect of Icotinib Hydrochloride Tablets on NF2; 2)Preliminarily evaluate the safety and the patient's tolerance of the treatment of Icotinib; 3)Provide an objective basis for an enlarged randomized double-blind trial.", 'detailedDescription': "Neurofibromatosis type 2 (NF2) is a hereditary tumor predisposition syndrome caused by mutations in the NF2 tumor suppressor gene. Individuals with NF2 have a higher likelihood to develop multiple nervous system tumors, including schwannomas, meningiomas, and ependymomas. The hallmark of NF2 is bilateral vestibular schwannomas. Historically, most NF2 patients experience complete hearing loss either from tumor progression or after treatment of the tumors with surgery or radiation. Effective treatments are urgently needed for NF2 patients with progressive hearing loss because hearing loss is associated with impairment in social, emotional,and communication function and with increased depression.\n\nPrevious studies of NF2 patients treated with Erlotinib suggested that inhibition of epidermal growth factor receptor (EGFR) could result in hearing improvement and reduction in tumor size.\n\nMuch evidence implicates human epidermal growth factor (HER) receptors in vestibular schwannoma growth.Some studies have demonstrated that Merlin, the NF2 gene protein product, controls surface availability of the EGFR, ErbB2, and ErbB3 receptors in human and Drosophila models. Besides, cell culture models of mouse embryo fibroblasts (MEFs) support the role of EGFR in NF2-associated tumorigenesis. Nf2-deficient cells in culture lack contact-dependent inhibition of growth and continue to grow in confluent cultures. This effect appears to be mediated by EGFR signaling. Treatment of Nf2-deficient cells with EGFR inhibitors such as gefitinib can restore contact-dependent inhibition, suggesting that this class of drugs might be useful for NF2 patients with progressive vestibular schwannomas. In this way, Icotinib can inhibit the nutrition of the tumor and decrease the tumor's growth and metastasis. Based on these studies, we perform this clinical trial to known the treatment effect and tolerability of Icotinib on NF2."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients must be at the age of 16-50\n2. Patients must meet the diagnostic criteria for NF2, with bilateral acoustic neuroma and other central nervous system tumors\n3. Patients must not be treated with other drugs or radiation therapy recently\n4. Patients should live in Beijing or nearby and can be treated in hospital\n5. Patients must be healthy and not be seriously allergic with biological agents\n6. Patients must join the clinical trial voluntarily, with good compliance, cooperate with the researchers well, sign a written informed consent.\n\nExclusion Criteria:\n\n1. Treated with other drugs, surgery or radiation therapy recently\n2. Brainstem is compressed seriously, with hydrocephalus, need to be treated with surgery in short time\n3. Being pregnant or try to get pregnant, lactating women\n4. With acute or chronic infectious diseases\n5. With heart diseases, cardiac dysfunction or abnormal ECG\n6. With uncontrolled neural or mental diseases, poor compliance\n7. Not available for enhanced MRI\n8. Take part in any other clinical trial\n9. With other conditions that are considered not suitable for this clinical trial.'}, 'identificationModule': {'nctId': 'NCT02934256', 'acronym': 'Icotinib', 'briefTitle': 'Icotinib Study for Patients With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tiantan Hospital'}, 'officialTitle': 'Icotinib Hydrochloride Tablets Study for Patients With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors', 'orgStudyIdInfo': {'id': 'Tian-drug-neuro002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Icotinib，treatment effect evaluation', 'description': 'Patients use Icotinib hydrochloride tablets during the course of treatment. The drug dosage is 125mg/m3/d. Every course of treatment lasts three months. Patients are designed to receive total four courses of treatment if there is no disease progression.', 'interventionNames': ['Drug: Icotinib']}], 'interventions': [{'name': 'Icotinib', 'type': 'DRUG', 'otherNames': ['Icotinib Hydrochloride Tablets'], 'description': 'Method of drug administration:oral; Dosage: 125mg/m3/d; Course of treatment: 3 months;Total four treatment courses.', 'armGroupLabels': ['Icotinib，treatment effect evaluation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100050', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Tiantan Hospital Affiliated to Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100050', 'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Tiantan Hospital Affiliated to Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Pinan Liu', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Beijing Tiantan Hospital'}, {'name': 'Fu Zhao', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Neurosurgical Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Li Peng', 'class': 'OTHER'}, 'collaborators': [{'name': 'Betta Pharmaceuticals Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Li Peng', 'investigatorAffiliation': 'Beijing Tiantan Hospital'}}}}