Ensayo clínico en fase I-II de vinorelbina oral (Navelbine) en combinación con capecitabina en tratamiento de primera línea en pacientes con cáncer de mama avanzado - Not applicable

Pierre Fabre Ibérica, S.A.0 个研究点目标入组 63 人开始时间: 2010年4月15日最近更新: 2022年4月19日

适应症

试验速览

暂无简介。

•- Histological or cytologically confirmed advanced breast carcinoma (metastatic)
•- Informed consent prior to the inclusion
•- Age = 18 and = 70 years old
•- ECOG-OMS: 0, 1 or 2
•- 1rst line of chemotherapy at phase II. At phase I patients could have received chemotherapy for advanced disease.
•- Life expectancy › 3 months
•- Adequate bone marrow/haematological function
•- Adequate hepatic and renal function
•- At least one measurable or evaluable LESION according to RECIST criteria at phase I.
•- At least one measurable LESION according to RECIST criteria at phase II.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•-At phase II previous chemotherapy treatment for metastatic disease
•- Concurrent treatment with any other anti-cancer therapy
•- Pregnant or lactating or childbearing potential not using medically accepted contraception
•- Active disease of the central nervous system or brain or leptomeningealmetastasis
•- Patients with diabetic unbalance, uncontrolled high blood pressure, unbalanced heart failure, peptic ulcer, lack of alimentary canal integrity or malabsortion syndrome.
•- Active and uncontrolled infection
•- Peripheral neuropathy = grade 2 using NCI criteria
•- Malabsortion syndrome, major gastric resection or any other disease that affects the funtinallity of the gastrointestinal tractus

发起方

Pierre Fabre Ibérica, S.A.