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

• ClinicalTrials.gov Identifier: NCT01392235
• Recruitment Status: Completed
• First Posted: July 12, 2011
• Last Update Posted: January 22, 2019
• Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Collaborator: Sun Yat-sen University
• Information provided by (Responsible Party): Jiangsu HengRui Medicine Co., Ltd.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Recurrent Nasopharyngeal Carcinoma; Metastatic Nasopharyngeal Carcinoma	Drug: Famitinib	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 58 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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)
• Actual Study Start Date: July 2011
• Actual Primary Completion Date: April 2015
• Actual Study Completion Date: August 2016

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. CBR(Clinical Benefit Rate) [ Time Frame: 12 weeks ]
   To evaluate the efficacy (clinical benefit rate) of single-agent famitinib in patients with recurrent or metastatic NPC

Secondary Outcome Measures :

1. ORR (Objective Response Rate) [ Time Frame: 12 weeks ]
2. PFS(Progress Free Survival) [ Time Frame: 3 years ]
3. DCR(Disease Control Rate) [ Time Frame: 12 weeks ]
4. OS(Sverall Survival) [ Time Frame: 3 years ]
5. To evaluate the safety and tolerability [ Time Frame: 3 years ]
   Number of participants with adverse events and serious adverse events.In addition,estimating their relationship with Famitinib.
6. QoL(Quality of Life) [ Time Frame: 3 years ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

China, Guangdong

Department of Medical Oncology, Cancer Center, Sun Yet-sen University

Guangzhou, Guangdong, China, 510060

Sponsors and Collaborators

Jiangsu HengRui Medicine Co., Ltd.

Sun Yat-sen University

More Information

• Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
• ClinicalTrials.gov Identifier: NCT01392235
• Other Study ID Numbers: FMTN-II-NPC
• First Posted: July 12, 2011
• Last Update Posted: January 22, 2019
• Last Verified: December 2018

Keywords provided by Jiangsu HengRui Medicine Co., Ltd.:

Recurrent and/or Metastatic Nasopharyngeal Carcinoma (NPC)

Additional relevant MeSH terms:

Carcinoma; Nasopharyngeal Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases