Concurrent Chemoradiotherapy With Famitinib for Patients With Locally Advanced Nasopharyngeal Carcinoma

NCT01462474 | Completed Phase 1 DMC

• 1 other identifier: FMTN-I-LNPC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced Nasopharyngeal Carcinoma

Keywords

Concurrent Chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• Dose-limiting toxicity (DLT) and maximum tolerated dose (MTD)

  To evaluate the DLT and MTD in patients with Concurrent Chemoradiotherapy With Famitinib

  3 weeks

Secondary Outcomes (8)

• ORR (Objective Response Rate)

  12 weeks after treatment

• OS(Overall Survival)

  2 years and 3 years

• DFMR(Distant Free Metastases Rate)

  2 years and 3 years

• DFSR(Disease Free Survival Rate)

  2 years and 3 years

• LFRSR(Local Free Recurrence Survival Rate)

  2 years and 3 years

Study Arms (1)

Drug: Famitinib

EXPERIMENTAL

Drug: Famitinib; Drug: Cisplatin; Radiation: radiation（IMRT）

Interventions

Famitinib DRUG

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: Famitinib

Cisplatin DRUG

100 mg/m2, D1, D22, and D43(q3w)

Drug: Famitinib

radiation（IMRT） RADIATION

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

Drug: Famitinib

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead
• Sun Yat-sen University: collaborator

Study Sites (1)

Department of Medical Oncology, Cancer Center, Sun Yet-sen University

Guangzhou, Guangdong, China

Location

MeSH Terms

Interventions

famitinib; Cisplatin

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2011
• First Posted: October 31, 2011
• Study Start: October 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: January 1, 2016
• Last Updated: April 18, 2018

Record last verified: 2011-11

Locations

CN (1)