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

NCT01392235 | Completed Phase 2 DMC

• 1 other identifier: FMTN-II-NPC
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Nasopharyngeal Carcinoma; Metastatic Nasopharyngeal Carcinoma

Keywords

Recurrent and/or Metastatic Nasopharyngeal Carcinoma (NPC)

Outcome Measures

Primary Outcomes (1)

• CBR(Clinical Benefit Rate)

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

  12 weeks

Secondary Outcomes (6)

• ORR (Objective Response Rate)

  12 weeks

• PFS(Progress Free Survival)

  3 years

• DCR(Disease Control Rate)

  12 weeks

• OS(Sverall Survival)

  3 years

• To evaluate the safety and tolerability

  3 years

Study Arms (1)

Drug: Famitinib

EXPERIMENTAL

Drug: Famitinib

Interventions

Famitinib DRUG

25 mg qd p.o. and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Drug: Famitinib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead
• Sun Yat-sen University: collaborator

Study Sites (1)

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

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

famitinib

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2011
• First Posted: July 12, 2011
• Study Start: July 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: August 1, 2016
• Last Updated: January 22, 2019

Record last verified: 2018-12

Locations

CN (1)