EUCTR2009-011217-24-BG进行中（未招募）不适用
A Phase 1b/2, Multicenter, Open-label, Dose-escalation and Confirmation Study of Eribulin in Combination with Capecitabine
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 76
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
- All
入选标准
- •Subjects in Dose-escalation cohorts (Phase 1b):
- •1) Histologically or cytologically confirmed cancer that is advanced and/or metastatic
- •2) Resistant/refractory to approved therapies (defined as progressive
- •disease during or within 6 months after the last anti-cancer therapy) or
- •for whom single agent capecitabine at this dose level and schedule
- •would be a reasonable treatment option in the opinion of the investigator
- •3) Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 2
- •4) For subjects that previously received capecitabine all capecitabine
- •related toxicities must have completely resolved.
- •Subjects in Dose-confirmation cohorts (Phase 2):
- •1) Histologically or cytologically confirmed carcinoma of the breast that is advanced and/or metastatic
- •2) Received up to three prior chemotherapy regimens in any setting
- •(sequential neo-adjuvant/adjuvant treatment counting as one regimen)
- •3) Chemotherapy regimens must have included an anthracycline (unless
- •anthracycline containing chemotherapy is inappropriate) and a taxane,
- •either in combination or in separate regimens
- •4) No prior treatment with capecitabine in any setting
- •5) At least one lesion of = 1.5cm in longest diameter for non-lymph nodes and =1.5cm in shortest diameter for lymph nodes which is serially measurable according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- •6) ECOG-PS 0 or 1
- •General inclusion criteria:
- •1) Adequate bone marrow function:
- •absolute neutrophil count (ANC) = 1.5 x 10 9/L, hemoglobin = 10.0 g/dL (this may have been corrected by growth factor or transfusion), and platelet count = 100 x 109/L
- •2) Adequate liver function as evidenced by bilirubin = 1.5 times the upper limits of normal (ULN) and alkaline phosphatase, alanine
- •aminotransferase (ALT), and aspartate aminotransferase (AST)
- •= 3 x ULN (in the case of liver metastases = 5 x ULN)
- •3) Adequate renal function as evidenced by calculated creatinine clearance = 50 mL/min as per the Cockcroft-Gault formula or radioisotope measurement
- •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) Suspected dihydropyrimidine dehydrogenase (DPD) deficiency
- •2) Prior participation in an eribulin clinical study, even if not assigned to
- •eribulin treatment
- •3) Pre-existing neuropathy > Grade 2
- •4) Subjects with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of
- •corticosteroids for this indication for at least 4 weeks before starting
- •study treatment. Any symptoms attributed to brain metastases must be stable for at least 4 weeks before starting study treatment; radiographic stability should be determined by comparing contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI) brain scan performed during screening to a prior scan performed at least 4 weeks earlier.
- •5) Electrocardiogram (ECG) with QTc interval > 470 msec
研究者
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