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A Single-arm, Open, Multicenter, Phase II Study of Famitinib as ≥Third Line Treatment in Patients With Recurrent and/or Metastatic Nasopharyngeal Carcinoma (NPC)


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Recurrent Nasopharyngeal Carcinoma, Metastatic Nasopharyngeal Carcinoma

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Trial Information

A Single-arm, Open, Multicenter, Phase II Study of Famitinib as ≥Third Line Treatment in Patients With Recurrent and/or Metastatic Nasopharyngeal Carcinoma (NPC)


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

CBR(Clinical Benefit Rate)

Outcome Description:

To evaluate the efficacy (clinical benefit rate) of single-agent famitinib in patients with recurrent or metastatic NPC

Outcome Time Frame:

12 weeks

Safety Issue:

No

Authority:

China: Food and Drug Administration

Study ID:

FMTN-II-NPC

NCT ID:

NCT01392235

Start Date:

June 2011

Completion Date:

March 2012

Related Keywords:

  • Recurrent Nasopharyngeal Carcinoma
  • Metastatic Nasopharyngeal Carcinoma
  • Recurrent and/or Metastatic Nasopharyngeal Carcinoma (NPC)
  • Carcinoma
  • Nasopharyngeal Neoplasms

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