Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-25 @ 7:49 PM
Study NCT ID:
NCT01392235
Status:
COMPLETED
Last Update Posted:
2019-01-22
First Post:
2011-07-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Famitinib in Treating Patients With Recurrent and/or Metastatic Nasopharyngeal Carcinoma (NPC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077274', 'term': 'Nasopharyngeal Carcinoma'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009303', 'term': 'Nasopharyngeal Neoplasms'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009302', 'term': 'Nasopharyngeal Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C584390', 'term': 'famitinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-17', 'studyFirstSubmitDate': '2011-07-03', 'studyFirstSubmitQcDate': '2011-07-11', 'lastUpdatePostDateStruct': {'date': '2019-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CBR(Clinical Benefit Rate)', 'timeFrame': '12 weeks', 'description': 'To evaluate the efficacy (clinical benefit rate) of single-agent famitinib in patients with recurrent or metastatic NPC'}], 'secondaryOutcomes': [{'measure': 'ORR (Objective Response Rate)', 'timeFrame': '12 weeks'}, {'measure': 'PFS(Progress Free Survival)', 'timeFrame': '3 years'}, {'measure': 'DCR(Disease Control Rate)', 'timeFrame': '12 weeks'}, {'measure': 'OS(Sverall Survival)', 'timeFrame': '3 years'}, {'measure': 'To evaluate the safety and tolerability', 'timeFrame': '3 years', 'description': 'Number of participants with adverse events and serious adverse events.In addition,estimating their relationship with Famitinib.'}, {'measure': 'QoL(Quality of Life)', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Recurrent and/or Metastatic Nasopharyngeal Carcinoma (NPC)'], 'conditions': ['Recurrent Nasopharyngeal Carcinoma', 'Metastatic Nasopharyngeal Carcinoma']}, 'descriptionModule': {'briefSummary': "RATIONALE: Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and Flt3. Phase I study has shown that the drug's toxicity is manageable.\n\nPURPOSE: This phase II trial is studying how well famitinib works in treating patients with recurrent and/or metastatic NPC."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically or cytologic confirmed recurrent and/or metastatic nasopharyngeal carcinoma( NPC )\n* Have failed for ≥2 lines of chemotherapy\n* At least one measurable lesion, larger than 10 mm in diameter by spiral CT scan(scanning layer ≤ 5 mm )\n* ≥ 18 and ≤ 70 years of age\n* ECOG performance scale 0-2\n* Life expectancy of more than 3 months\n* More than 4 weeks after operation, chemotherapy, radiotherapy, cytotoxic agents or tyrosine kinase inhibitors\n* Adequate hepatic, renal, heart, and hematologic functions (hemoglobin ≥ 90g/L, platelets ≥ 80×10\\^9/L, neutrophils ≥ 1.5×10\\^9/L, 24-hour urinary protein ≤ 1.0 g total bilirubin \\< 1.25×the upper limit of normal(ULN), and serum transaminase \\< 1.5×the ULN (If liver metastases, serum transaminase\\< 2.5×the ULN), serum creatine ≤ 1x ULN, creatinine clearance rate \\> 50ml/min, Cholesterol≤7.75 mmol/L and triglyceride≤2.5 x ULN, LVEF: ≥ 50%\n* Patients could provide 4-6 pieces of organization wax or pathological section\n* Female: All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 6 months after the last dose of test article. Child bearing potential, a negative urine or serum pregnancy test result before initiating Famitinib. Male: All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 6 months after the last dose of test article.\n* Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.\n\nExclusion Criteria:\n\n* Prior therapy with tyrosine kinase -inhibitor agent targeting at VEGFR, PDGFR and c-Kit\n* Prior radiotherapy more than 2 courses\n* Before or at the same time any, second malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix\n* Less than 4 weeks from the last clinical trial\n* Any factors that influence the usage of oral administration\n* Known Spinal Cord compression or diseases of brain or pia mater by CT /MRI screening\n* Imageology shows that tumor lesion less than 5 mm to great vessels\n* Preexisting uncontrolled hypertension defined as more than 140/90 mmHg despite using single medical therapy, more than cla ss I (NCI CTCAE 3.0 ) myocardial ischemia, arrhythmia, or cardiac insufficiency\n* URT: urine protein ≥ ++ and \\> 1.0 g of 24 h\n* Long-term untreated wounds or fractures\n* Blood coagulation abnormal, having hemorrhagic tendency (eg. active peptic ulcer disease) or receiving the therapy of thrombolysis or anticoagulation.\n* Within 6 months before the first treatment occurrs artery / venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, etc.\n* Application of anticoagulants or vitamin K antagonists such as warfarin, heparin or its analogues; If the prothrombin time international normalized ratio (INR) ≤ 1.5, with the purpose of prevention, the use of small doses of warfarin (1mg orally, once daily) or low-dose aspirin (between 80mg to 100mg daily) is allowed\n* Preexisting thyroid dysfunction, even using medical therapy, thyroid function cannot maintain in the normal range\n* Abuse of Psychiatric drugs or dysphrenia\n* Viral hepatitis type B or type C\n* Immunodeficiency: HIV positive, or other acquired immunodeficiency, congenital immunodeficiency, or organ transplantation\n* Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study."}, 'identificationModule': {'nctId': 'NCT01392235', 'briefTitle': 'Famitinib in Treating Patients With Recurrent and/or Metastatic Nasopharyngeal Carcinoma (NPC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'A Single-arm, Open, Multicenter, Phase II Study of Famitinib as ≥Third Line Treatment in Patients With Recurrent and/or Metastatic Nasopharyngeal Carcinoma (NPC)', 'orgStudyIdInfo': {'id': 'FMTN-II-NPC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Drug: Famitinib', 'interventionNames': ['Drug: Famitinib']}], 'interventions': [{'name': 'Famitinib', 'type': 'DRUG', 'description': '25 mg qd p.o. and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent', 'armGroupLabels': ['Drug: Famitinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Department of Medical Oncology, Cancer Center, Sun Yet-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Sun Yat-sen University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}