Status:
COMPLETED
Concurrent Chemoradiotherapy With Famitinib for Patients With Locally Advanced Nasopharyngeal Carcinoma
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Collaborating Sponsors:
Sun Yat-sen University
Conditions:
Locally Advanced Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
RATIONALE: Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and Flt3. Phase I study of mono famitinib has shown that the drug's toxicity is manageable. PURPOSE: ...
Eligibility Criteria
Inclusion
- Histologically confirmed nasopharyngeal differentiation or undifferentiation carcinoma, WHO II or III
- Newly diagnosed T3-4N1（exception metastatic uni or bil retropharyngeal lymph nodes N1） or any TN2-3(7th UICC/AJCC) locally advanced nasopharyngeal carcinoma
- 18-65 years of age
- ECOG performance status of 0 or 1
- Life expectancy of more than 6 months
- At least one measurable lesion :MRI scan larger than 10 mm in diameter, malignant lymph nodes larger than 10 mm in short axis
- 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.
- Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.
Exclusion
- Before or at the same time any second malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- Any factors that influence the usage of oral administration
- Known Spinal Cord compression or diseases of brain or pia mater by CT /MRI Screening
- Imageology shows that tumor lesion less than 5 mm to great vessels(internal carotid and jugular vein)
- Hemoglobin \< 90g/L, platelets \< 100×10\^9/L, neutrophils \< 2×10\^9/L, total bilirubin ≥ 1.25×the upper limit of normal(ULN), ALT\\AST ≥ 1.5x ULN), serum creatine \> 1x ULN, creatinine clearance rate \< 60ml/min, Cholesterol \> 7.75 mmol/L and triglyceride \> 3 mmol/L, LVEF: \< LLN
- Hypertensive( more than 140/90 mmHg ), more than class I (NCI CTCAE 3.0 ) myocardial ischemia, arrhythmia(including QTcF:male ≥ 450 ms, female ≥470 ms), or cardiac insufficiency
- URT: urine protein ≥ ++ and \> 1.0 g of 24 h
- Long-term untreated wounds or fractures
- PT, APTT, TT, Fbg abnormal, having hemorrhagic tendency (eg. active peptic ulcer disease) or receiving the therapy of thrombolysis or anticoagulation
- Before the first treatment occurs artery / venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, etc
- Preexisting thyroid dysfunction, even using medical therapy, thyroid function cannot maintain in the normal range
- Abuse of Psychiatric drugs or dysphrenia
- Subject of Viral hepatitis type B or type C
- Subject of immunodeficiency: HIV positive, or other acquired immunodeficiency, congenital immunodeficiency, or organ transplantation
- With drug CYP3A4 inhibitor, inducer, or substrate
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01462474
Start Date
October 1 2011
End Date
January 1 2016
Last Update
April 18 2018
Active Locations (1)
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1
Department of Medical Oncology, Cancer Center, Sun Yet-sen University
Guangzhou, Guangdong, China