Famitinib in Treating Patients With Recurrent and/or Metastatic Nasopharyngeal Carcinoma (NPC)
Phase 2
Completed
- Conditions
- Recurrent Nasopharyngeal CarcinomaMetastatic Nasopharyngeal Carcinoma
- Interventions
- Registration Number
- NCT01392235
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Drug: Famitinib Famitinib -
- Primary Outcome Measures
Name Time Method CBR(Clinical Benefit Rate) 12 weeks To evaluate the efficacy (clinical benefit rate) of single-agent famitinib in patients with recurrent or metastatic NPC
- Secondary Outcome Measures
Name Time Method DCR(Disease Control Rate) 12 weeks To evaluate the safety and tolerability 3 years Number of participants with adverse events and serious adverse events.In addition,estimating their relationship with Famitinib.
QoL(Quality of Life) 3 years ORR (Objective Response Rate) 12 weeks PFS(Progress Free Survival) 3 years OS(Sverall Survival) 3 years
Trial Locations
- Locations (1)
Department of Medical Oncology, Cancer Center, Sun Yet-sen University
🇨🇳Guangzhou, Guangdong, China