Famitinib in Treating Patients With Recurrent and/or Metastatic Nasopharyngeal Carcinoma (NPC)

Hengrui Medicine

Status and phase

Completed

Phase 2

Conditions

Recurrent Nasopharyngeal Carcinoma

Metastatic Nasopharyngeal Carcinoma

Treatments

Drug: Famitinib

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01392235

FMTN-II-NPC

Details and patient eligibility

About

RATIONALE: Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and Flt3. Phase I study has shown that the drug's toxicity is manageable.

PURPOSE: This phase II trial is studying how well famitinib works in treating patients with recurrent and/or metastatic NPC.

Enrollment

58 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically or cytologic confirmed recurrent and/or metastatic nasopharyngeal carcinoma( NPC )
Have failed for ≥2 lines of chemotherapy
At least one measurable lesion, larger than 10 mm in diameter by spiral CT scan(scanning layer ≤ 5 mm )
≥ 18 and ≤ 70 years of age
ECOG performance scale 0-2
Life expectancy of more than 3 months
More than 4 weeks after operation, chemotherapy, radiotherapy, cytotoxic agents or tyrosine kinase inhibitors
Adequate hepatic, renal, heart, and hematologic functions (hemoglobin ≥ 90g/L, platelets ≥ 80×10^9/L, neutrophils ≥ 1.5×10^9/L, 24-hour urinary protein ≤ 1.0 g total bilirubin < 1.25×the upper limit of normal(ULN), and serum transaminase < 1.5×the ULN (If liver metastases, serum transaminase< 2.5×the ULN), serum creatine ≤ 1x ULN, creatinine clearance rate > 50ml/min, Cholesterol≤7.75 mmol/L and triglyceride≤2.5 x ULN, LVEF: ≥ 50%
Patients could provide 4-6 pieces of organization wax or pathological section
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

Prior therapy with tyrosine kinase -inhibitor agent targeting at VEGFR, PDGFR and c-Kit
Prior radiotherapy more than 2 courses
Before or at the same time any, second malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
Less than 4 weeks from the last clinical trial
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
Preexisting uncontrolled hypertension defined as more than 140/90 mmHg despite using single medical therapy, more than cla ss I (NCI CTCAE 3.0 ) myocardial ischemia, arrhythmia, or cardiac insufficiency
URT: urine protein ≥ ++ and > 1.0 g of 24 h
Long-term untreated wounds or fractures
Blood coagulation abnormal, having hemorrhagic tendency (eg. active peptic ulcer disease) or receiving the therapy of thrombolysis or anticoagulation.
Within 6 months before the first treatment occurrs artery / venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, etc.
Application of anticoagulants or vitamin K antagonists such as warfarin, heparin or its analogues; If the prothrombin time international normalized ratio (INR) ≤ 1.5, with the purpose of prevention, the use of small doses of warfarin (1mg orally, once daily) or low-dose aspirin (between 80mg to 100mg daily) is allowed
Preexisting thyroid dysfunction, even using medical therapy, thyroid function cannot maintain in the normal range
Abuse of Psychiatric drugs or dysphrenia
Viral hepatitis type B or type C
Immunodeficiency: HIV positive, or other acquired immunodeficiency, congenital immunodeficiency, or organ transplantation
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.