EUCTR2008-006430-10-FI进行中（未招募）不适用
A multi-center, open label Phase II trial of TKI258 in FGFR1 amplified and non-amplified metastatic HER2 negative breast cancer. - N/A
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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 tested by FISH/CISH/SISH for FGFR1 amplification before study entry. 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 must have at least one measurable lesion as defined by RECIST
- •7.Patients with HR+ disease must have received:
- •at least 1 prior endocrine therapy in the metastatic setting
- •no more than 3 lines of chemotherapy in the metastatic setting
- •8.Patients with HR- disease must have received at least 1 and no more than 3 lines of chemotherapy in metastatic setting
- •9.Patient must be = 18 years old.
- •10.Patient’s WHO performance status equal to 0, 1 or 2.
- •Required baseline laboratory values:
- •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 brain metastases as assessed by radiologic imaging (e.g. CT, MRI). (Please note: The radiological confirmation is required for all patients at the baseline screening visit.)
- •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 or hormone therapy = 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/hormone therapy in a daily schedule = 7 days prior to starting study drug; patients who have received the last administration of chemotherapy/immunotherapy/hormone therapy in a weekly schedule = 2 weeks prior to starting study drug; patients who have received the last administration of chemotherapy/immunotherapy/hormone therapy in a 2-weekly schedule = 3 weeks prior to starting study drug; patients who have received the last administration of chemotherapy/immunotherapy/hormone therapy in a 3-weekly schedule = 4 weeks prior to starting study drug; patients who have received the last administration of chemotherapy/ immunotherapy/hormone therapy 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:
- •History or presence of serious uncontrolled ventricular arrhythmias or presence of atrial fibrillation
- •Clinically significant resting bradycardia (< 50 beats per minute)
- •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 two or more interventio
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