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
  Purpose

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.


Condition Intervention Phase
Recurrent Nasopharyngeal Carcinoma
Metastatic Nasopharyngeal Carcinoma
Drug: Famitinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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)

Resource links provided by NLM:


Further study details as provided by Jiangsu HengRui Medicine Co., Ltd.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 58
Study Start Date: June 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drug: Famitinib Drug: Famitinib
25 mg qd p.o. and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01392235

Contacts
Contact: Li Zhang 862087343088 zhangli6@mail.sysu.edu.cn
Contact: Haoyuan Jiang 862168868768 jianghy@shhrp.com

Locations
China, Guangdong
Department of Medical Oncology, Cancer Center, Sun Yet-sen University Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Li Zhang,    862087343088      
Principal Investigator: Li ZHANG, Dr         
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Sun Yat-sen University
  More Information

No publications provided

Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT01392235     History of Changes
Other Study ID Numbers: FMTN-II-NPC
Study First Received: July 3, 2011
Last Updated: February 8, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Jiangsu HengRui Medicine Co., Ltd.:
Recurrent and/or Metastatic Nasopharyngeal Carcinoma (NPC)

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Head and Neck Neoplasms
Nasopharyngeal Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Otorhinolaryngologic Neoplasms
Pharyngeal Neoplasms
Carcinoma
Otorhinolaryngologic Diseases
Pharyngeal Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 29, 2014