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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Jiangsu HengRui Medicine Co., Ltd..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Sun Yat-sen University
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01392235
First received: July 3, 2011
Last updated: February 8, 2012
Last verified: July 2011

July 3, 2011
February 8, 2012
June 2011
March 2012   (final data collection date for primary outcome measure)
CBR(Clinical Benefit Rate) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
To evaluate the efficacy (clinical benefit rate) of single-agent famitinib in patients with recurrent or metastatic NPC
Same as current
Complete list of historical versions of study NCT01392235 on ClinicalTrials.gov Archive Site
  • ORR (Objective Response Rate) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • PFS(Progress Free Survival) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • DCR(Disease Control Rate) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • OS(Sverall Survival) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To evaluate the safety and tolerability [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Number of participants with adverse events and serious adverse events.In addition,estimating their relationship with Famitinib.
  • QoL(Quality of Life) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Famitinib in Treating Patients With Recurrent and/or Metastatic Nasopharyngeal Carcinoma (NPC)
A Single-arm, Open, Multicenter, Phase II Study of Famitinib as ≥Third Line Treatment in Patients With Recurrent and/or Metastatic Nasopharyngeal Carcinoma (NPC)

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Recurrent Nasopharyngeal Carcinoma
  • Metastatic Nasopharyngeal Carcinoma
Drug: Famitinib
25 mg qd p.o. and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Experimental: Drug: Famitinib
Intervention: Drug: Famitinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
58
March 2012
March 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact: Li Zhang 862087343088 zhangli6@mail.sysu.edu.cn
Contact: Haoyuan Jiang 862168868768 jianghy@shhrp.com
China
 
NCT01392235
FMTN-II-NPC
Yes
Jiangsu HengRui Medicine Co., Ltd.
Jiangsu HengRui Medicine Co., Ltd.
Sun Yat-sen University
Not Provided
Jiangsu HengRui Medicine Co., Ltd.
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP