EUCTR2008-006430-10-ES进行中（未招募）不适用
Estudio Fase II, multicéntrico, abierto, de TKI258 en cáncer de mama HER2 negativo metastático con y sin amplificación del FGFR1
ovartis Farmaceútica S.A.0 个研究点目标入组 200 人开始时间: 2009年5月22日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1.Female patients with histological confirmation of adenocarinoma of the breast, presenting with metastatic disease.
- •2.The primary tumor, metastatic axillary lymph nodes or biopsy of metastatic tumor must have been locally tested by FISH/CISH for FGFR1 amplification. Tumor material must be available for central testing.
- •3.HER2 and hormone receptors (ER/PgR) status of breast cancer must have been previously determined.
- •4.Patients must have HER2 negative breast cancer.
- •5.Patients must have a documented disease progression as defined by RECIST at baseline.
- •6.Patients with HR+ disease must have received adjuvant endocrine therapy and at least one line and no more that three lines of chemotherapy in the metastatic setting.
- •- Patients with newly diagnosed metastatic disease must have received at least one line endocrine therapy and chemotherapy for metastatic disease.
- •7.Patients with HR- disease must have received:
- •- djuvant chemotherapy and at least one line and no more than three lines of chemotherapy in metastatic setting
- •- Patients who did not receive adjuvant chemotherapy must have received two lines of chemotherapy in the metastatic setting.
- •8.Patient must be ≥ 18 years old.
- •9.Patient´s WHO performance status equal to 0, 1 or 2.
- •Required baseline laboratory values:
- •10.Electrolytes (Ca2+, Na+, Mg2+, K+, phosphorous) level within normal limit
- •11.Absolute Neutrophil Count (ANC)≥ 1.5 x 109/L
- •12.Hemoglobin ≥ 9 g/dl
- •13.Platelets ≥ 100 x 109/L
- •14.Serum creatinine ≤ 1.5 x ULN
- •15.AST/SGOT and ALT/SGPT ≤ 2.5 x Upper Limit of Normal (ULN) or ≤ 5.0 x ULN if liver metastases are present
- •16.Serum bilirubin ≤ 1.5 x ULN
- •17.All patients must have signed and dated an informed consent form.
- •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
排除标准
- •1.Patients with known brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases
- •2.Patients with history of another malignancy within the last 5 years prior to study entry, except cured basal cell carcinoma of the skin or excised carcinoma in situ of the cervix.
- •3.Patients who have received the last administration of chemotherapy or immunotherapy ≤ the timeframe defined below after the end of the cycle of the last treatment, prior to starting study drug, or who have not recovered from the side effects of such therapy: patients who have received the last administration of chemotherapy/immunotherapy in a daily schedule ≤ 7 days prior to starting study drug; patients who have received the last administration of chemotherapy/immunotherapy in a weekly schedule ≤ 2 weeks prior to starting study drug; patients who have received the last administration of chemotherapy/immunotherapy in a 2-weekly schedule ≤3 weeks prior to starting study drug; patients who have received the last administration of chemotherapy/immunotherapy in a 3-weekly schedule ≤4 weeks prior to starting study drug; patients who have received the last administration of chemotherapy/ immunotherapy in a 4-weekly schedule ≤ 5 weeks prior to starting study drug.
- •Patients who have received the last administration of nitrosourea, mitomycin-C ≤ 6 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy.
- •4.Patients who received a continuous dosing small molecule therapeutic ≤ 7 days prior to starting study drug or who have not recovered from the side effects of such therapy
- •5.Patients who received the last administration of biologic therapy ≤6 weeks prior to starting study drug or who have not recovered from the side effects of such therapy
- •6.Patients who have received any other investigational agents ≤ 4 weeks prior to starting study drug or who have not recovered from the side effects of such therapy
- •7.Patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy.
- •8.Patients who have undergone major surgery ≤ 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy.
- •Any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study :
- •9.Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
- •- Congenital long QT syndrome
- •- History or presence of ventricular arrhythmias or presence of atrial fibrilation
- •- Clinically significant resting bradycardia (< 50 beats per minute)
- •- QTc > 480 msec on screening ECG.
- •- LVEF assessed by 2-D echocardiogram (ECHO) or Multiple gated acquisition scanning (MUGA), < 45 %.
- •10.Any of the following within 6 months prior to study entry: myocardial infarction, severe/unstable angina, CABG, Congestive Heart Failure, Cerebrovascular Accident, Transient Ischemic Attack, Pulmonary Embolism
- •11.Uncontrolled hypertension defined by a SBP > 150 mm Hg and/or DBP > 100 mm Hg, with or without anti-hypertensive medication.
- •12.Previous pericarditis; clinically significant pleural effusion in the previous 12 months or current ascites requiring
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