Overview
Concurrent Chemoradiotherapy With Famitinib for Patients With Locally Advanced Nasopharyngeal Carcinoma
Status:
Completed
Completed
Trial end date:
2016-01-01
2016-01-01
Target enrollment:
0
0
Participant gender:
All
All
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: This phase I trial is studying the safety and tolerance of concurrent chemoradiotherapy with famitinib for patients with locally advanced nasopharyngeal carcinoma.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.Collaborator:
Sun Yat-sen UniversityTreatments:
Cisplatin
Criteria
Inclusion Criteria:- 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 Criteria:
- 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