- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02356991
A Study of Famitinib in Patients With Advanced Non-squamous and Non-Small Cell Lung Cancer (NSCLC)
A Randomized,Double-Blind, Placebo-Controlled, Multicenter, Phase II Study of Famitinib in Patients With Advanced Non-squamous and Non-Small Cell Lung Cancer (NSCLC)
Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and Flt3. Phase I study has shown that the toxicity is manageable.
The purpose of this study is to evaluate the efficacy and safety profile of Famitinib in patients with Advanced Non-squamous and Non-Small Cell Lung Cancer (NSCLC).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Shanghai, Porcelana, 200433
- Tongji University Affiliated Shanghai Pulmonary Hospital
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Guangdong
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Guangzhou, Guangdong, Porcelana, 510060
- Cancer Hospital of Guangzhou Sun Yat-sen University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 1.Age: 18-70;
- 2.Advanced (IV phase)non squamous NSCLC confirmed by pathology, with measurable lesions (tumour lesions ≥10mm in longest diameter, malignant lymph nodes ≥15mm in short axis, scanning layer ≤ 5 mm, measurable lesions not received locoregional theraphy ,such as radiotherapy or frozen therapy);
3.Previously treated with EGFR inhibitors or chemotherapy,second line or above treatment failure:
- a.for EGFR wild type, second line or above treatment failure(at least previously treated with platinum-based chemotherapy)
- b.for EGFR mutation type, third line or above treatment failure(at least previously treated with Platinum-based chemotherapy and EGFR inhibitors)
- 4.ECOG Performance Status of 0 or 1;
- 5.Life expectancy of at least 3 months;
- 6.Damage caused by other anti-tumor therapy has been restored, the nitroso or mitomycin treatment interval ≥ 6 weeks; other cytotoxic drugs, radiotherapy or surgery for ≥ 4 weeks; EGFR molecular targeted drugs for ≥ 2 weeks;
7.Participants have inadequate organ and marrow function as defined below:
- Hemoglobin ≥ 90g/L ( no blood transfusion in 2 weeks)
- Absolute neutrophil count (ANC) ≥ 1.5×10^9/L
- PLT ≥ 80×10^9/L
- Bilirubin < 1.25 × ULN
- ALT < 2.5 × ULN
- AST < 2.5 × ULN
- serum creatinine < 1.25 × ULN, and endogenous Cr clearance > 45 ml/min(Cockcroft-Gault Formula)
- cholesterol ≤ 1.5×ULN and triglyceride≤ 2.5 × ULN
- LVEF≥ LLN by Color Doppler Ultrasonography
- 8.Female: Child bearing potential, a negative urine or serum pregnancy test result 7 days before initiating famitinib.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 8 weeks after the last dose of test article. 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 8 weeks after the last dose of test article;
- 9.Ability to understand and willingness to sign a written informed consent. Good compliance with follow-up visits.
Exclusion Criteria:
- 1.Squamous cell carcinoma (including adenosquamous carcinoma, undifferentiated carcinoma); small cell lung cancer (lung cancer including small cell carcinoma and non-small cell hybrid);
- 2.Known brain metastases, spinal cord compression, cancer meningitis, or screening CT or MRI examination revealed brain or leptomeningeal disease
- 3.Patients with hypertension using combination therapy (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg). Patients with more than Class I, myocardial ischemia or myocardial infarction, arrhythmia (including QT interval ≥ 450ms for male and 470ms for female) and class II cardiac dysfunction,according to NCI-CTC AE 4.0;
- 4.Variety of factors that affect the oral medication (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction);
- 5.Coagulation abnormalities (PT or PT-INR > 1.5 ULN, and APTT > 1.5 ULN), bleeding tendency (eg, active peptic ulcer) or are receiving thrombolytic or anticoagulant therapy;
- 6.Distance between tumours lesions and major blood vessels with radiographical evidence (CT or MRI) ≥5mm.
- 7.Pulmonary hemorrhage/ bleeding event ≥ CTCAE gr. 1 (including Hemoptysis≥2.5ml or half teaspoon)within four weeks of the first dose of the study drug; Any other hemorrhage/ bleeding event ≥ CTCAE gr. 2 within four weeks of the first dose of the study drug;
- 8.Long-term untreated wounds or fractures;
- 9.Thrombotic or embolic venous or arterial events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 12 months prior to the first dose of study drug;
- 10.Urine protein ≥ + + and confirmed the 24-hour urinary protein>1.0 g;
- 11.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) ,low-dose heparin (0.6~1.2 ×10^8 U daily) low-dose aspirin (less than 100mg daily) is allowed;
- 12.Preexisting thyroid dysfunction, even using medical therapy, thyroid function cannot maintain in the normal range;
- 13.Pre-existing ascites and/or clinically significant pleural effusion;
- 14.Active hepatitis C and/or B infection;
- 15.Abuse of psychiatric drugs or dysphrenia;
- 16.Participated in other anti-cancer clinical trials within four weeks;
- 17.Prior therapy with VEGFR inhibitor,except Bevacizumab (Avastin);
- 18.Past or suffering from other cancer, but other than cure basal cell carcinoma and cervical carcinoma in situ.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Famitinib
Famitinib 25 mg qd p.o., 4 weeks per cycle.The treatment continued until disease progression or intolerable toxicity happened or patients withdrawal of consent.
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Comparador de placebos: Placebo
Placebo 25 mg qd p.o., 4 weeks per cycle.The treatment continued until disease progression or intolerable toxicity happened or patients withdrawal of consent.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Progress free survival (PFS)
Periodo de tiempo: 1.5 years
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1.5 years
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Supervivencia general (SG)
Periodo de tiempo: 2 años
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2 años
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Tasa de respuesta objetiva (ORR)
Periodo de tiempo: 1 año
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1 año
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Tasa de Control de Enfermedades (DCR)
Periodo de tiempo: 1 año
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1 año
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Calidad de vida
Periodo de tiempo: Visita del ciclo de 28 días hasta el progreso de la enfermedad
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Visita del ciclo de 28 días hasta el progreso de la enfermedad
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Li Zhang, M.D., Cancer Hospital of Guangzhou Sun Yat-sen University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HR-FMTN- Ⅱ-NSCLC-MON
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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