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Concurrent Chemoradiotherapy With Famitinib for Patients With Locally Advanced Nasopharyngeal Carcinoma (FMTN-I-LNPC)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2011 by Jiangsu HengRui Medicine Co., Ltd..
Recruitment status was:  Recruiting
Sun Yat-sen University
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd. Identifier:
First received: October 27, 2011
Last updated: November 14, 2011
Last verified: November 2011

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.

Condition Intervention Phase
Locally Advanced Nasopharyngeal Carcinoma
Drug: Famitinib
Drug: Cisplatin
Radiation: radiation(IMRT)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Concurrent Chemoradiotherapy With Famitinib for Patients With Locally Advanced Nasopharyngeal Carcinoma

Resource links provided by NLM:

Further study details as provided by Jiangsu HengRui Medicine Co., Ltd.:

Primary Outcome Measures:
  • Dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) [ Time Frame: 3 weeks ]
    To evaluate the DLT and MTD in patients with Concurrent Chemoradiotherapy With Famitinib

Secondary Outcome Measures:
  • ORR (Objective Response Rate) [ Time Frame: 12 weeks after treatment ]
  • OS(Overall Survival) [ Time Frame: 2 years and 3 years ]
  • DFMR(Distant Free Metastases Rate) [ Time Frame: 2 years and 3 years ]
  • DFSR(Disease Free Survival Rate) [ Time Frame: 2 years and 3 years ]
  • LFRSR(Local Free Recurrence Survival Rate) [ Time Frame: 2 years and 3 years ]
  • Quantitative evaluation of the blood perfusion of the metastatic cervical lymph nodes by dynamic contrast-enhanced ultrasonography after a loading dose of famitinib for 14 days [ Time Frame: 2 weeks ]
  • To identify the tumor's molecular profiles in patients with NPCs [ Time Frame: 2 years ]
  • To measure the changes of serum c-Kit,VEGF,Filt,KDR,and PDGFR [ Time Frame: 2 years ]

Estimated Enrollment: 21
Study Start Date: October 2011
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drug: Famitinib Drug: Famitinib
Either at 12.5 mg, 16.5 mg、20 mg or 25 mg qd p.o., 2 weeks before concurrent chemoradiotherapy and D1-D49, exception D1, D22, and D43.
Drug: Cisplatin
100 mg/m2, D1, D22, and D43(q3w)
Radiation: radiation(IMRT)
IMRT (Intensity-Modulated Radiation Therapy). Radiation is delivered to GTV at 70 Gy in 32-33 fractions, CTV1 at 60 Gy in 32-33 fractions and CTV2 at 54 Gy in 32-33 fractions


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01462474

China, Guangdong
Department of Medical Oncology, Cancer Center, Sun Yet-sen University Recruiting
Guangzhou, Guangdong, China
Contact: Jun Ma, MD    8602087343469   
Contact: Haiqiang Mai, MD    8602087343469   
Principal Investigator: Jun Ma, MD         
Principal Investigator: Haiqiang Mai, MD         
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Sun Yat-sen University
  More Information

Responsible Party: Jiangsu HengRui Medicine Co., Ltd. Identifier: NCT01462474     History of Changes
Other Study ID Numbers: FMTN-I-LNPC
Study First Received: October 27, 2011
Last Updated: November 14, 2011

Keywords provided by Jiangsu HengRui Medicine Co., Ltd.:
Concurrent Chemoradiotherapy

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases processed this record on April 28, 2017