Concurrent Chemoradiotherapy With Famitinib for Patients With Locally Advanced Nasopharyngeal Carcinoma

Phase 1

Completed

• Conditions: Locally Advanced Nasopharyngeal Carcinoma
• Interventions: Drug: Famitinib; Drug: Cisplatin; Radiation: radiation（IMRT）

• Registration Number: NCT01462474
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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: This phase I trial is studying the safety and tolerance of concurrent chemoradiotherapy with famitinib for patients with locally advanced nasopharyngeal carcinoma.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-27
• Study First Submitted QC: 2011-10-27
• Study First Posted: 2011-10-31
• Status Verified: 2011-11
• Primary Completion: 2015-08
• Study Completion: 2016-01
• Last Update Submitted: 2018-04-16
• Last Update Posted: 2018-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Drug: Famitinib	Famitinib	-
Drug: Famitinib	radiation（IMRT）	-
Drug: Famitinib	Cisplatin	-

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicity (DLT) and maximum tolerated dose (MTD)	3 weeks	To evaluate the DLT and MTD in patients with Concurrent Chemoradiotherapy With Famitinib

Secondary Outcome Measures

Name	Time	Method
To identify the tumor's molecular profiles in patients with NPCs	2 years
ORR (Objective Response Rate)	12 weeks after treatment
OS(Overall Survival)	2 years and 3 years
DFSR(Disease Free Survival Rate)	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	2 weeks
To measure the changes of serum c-Kit，VEGF，Filt，KDR，and PDGFR	2 years
DFMR(Distant Free Metastases Rate)	2 years and 3 years
LFRSR(Local Free Recurrence Survival Rate)	2 years and 3 years

Trial Locations

Locations (1)

Department of Medical Oncology, Cancer Center, Sun Yet-sen University; 🇨🇳 Guangzhou, Guangdong, China