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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01392235
• Date of registration: 03/07/2011
• Primary sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Public title: Famitinib in Treating Patients With Recurrent and/or Metastatic Nasopharyngeal Carcinoma (NPC)
• Scientific title: A Single-arm, Open, Multicenter, Phase II Study of Famitinib as =Third Line Treatment in Patients With Recurrent and/or Metastatic Nasopharyngeal Carcinoma (NPC)
• Date of first enrolment: June 2011
• Target sample size: 58
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01392235
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

China

Contacts

• Name: Li Zhang,

• Name: Li Zhang

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Metastatic Nasopharyngeal Carcinoma

Recurrent Nasopharyngeal Carcinoma

Intervention(s)

Drug: Famitinib

Primary Outcome(s)

CBR(Clinical Benefit Rate) [Time Frame: 12 weeks]

Secondary Outcome(s)

DCR(Disease Control Rate) [Time Frame: 12 weeks]

ORR (Objective Response Rate) [Time Frame: 12 weeks]

OS(Sverall Survival) [Time Frame: 3 years]

PFS(Progress Free Survival) [Time Frame: 3 years]

QoL(Quality of Life) [Time Frame: 3 years]

To evaluate the safety and tolerability [Time Frame: 3 years]

Secondary ID(s)

FMTN-II-NPC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sun Yat-sen University