NCT00615940已完成2 期
A Phase 2, Two-arm, Double-blind, Multi-center, Randomized Study of the Combination of Oral WX-671 Plus Capecitabine vs. Capecitabine Monotherapy in First-line Her2-negative Metastatic Breast Cancer
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 20
- 主要终点
- Efficacy in terms of progression-free survival (PFS)
研究概览
简要总结
This randomized, double-blind, placebo controlled phase II trial is studying how well capecitabine works when given in combination with WX-671 or when given alone in treating patients receiving first-line therapy for her2negative metastatic breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females aged ≥ 18 years
- •Patients appropriate for palliative first-line, mono chemotherapy with capecitabine
- •Histological or cytological confirmed, non-inflammatory metastatic breast cancer
- •Availability of paraffin-embedded tumor tissue from the primary resection or biopsy of a metastatic lesion.
- •HER2-negative breast cancer
- •Complete staging within 2 weeks prior to randomization (4 weeks for bone scan).
- •Radiologically confirmed disease
- •ECOG performance status of ≤ 2
- •Ability to understand and willingness to voluntarily sign and date a written informed consent form before screening
- •Negative pregnancy test (urine or serum) within 3 days before first study drug for women of childbearing potential. Use of effective contraception during the study and for 3 months after stopping study drug treatment.
- •Normal organ and marrow function as defined by laboratory parameters (obtained within the screening period) within the following limits:
- •neutrophils >= 1.5 x 109/L;
- •platelets >= 100 x 109/L;
- •hemoglobin >= 9.0 g/dL (5.6 mmol/L).
- •total bilirubin <= 1.5 x upper limit of normal (ULN);
- •aspartate aminotransferase (AST)/ALT <= 2.5 x ULN (< 5.0 x ULN for patients with liver metastases);
- •serum creatinine <= 2 x ULN, or calculated creatinine clearance >45 mL/min according to Cockroft and Gault formula).
排除标准
- •Endocrine therapy completed within 2 weeks before the start of treatment (i.e. previous hormone therapy is allowed provided that there is a washout period of 2 weeks).
- •Prior chemotherapy or biologic therapy for metastatic disease.
- •Major surgery within 4 weeks prior to the start of treatment.
- •Other anti-cancer treatment (e.g. hormones) within 2 weeks before the start of treatment.
- •Treatment within 12 months with adjuvant 5-FU containing chemotherapy (regarded as indicating 5-FU resistance) and/or prior capecitabine therapy.
- •Radiation therapy. Palliative radiation of stable, non-target lesions more than 2 weeks before the start of treatment is allowed, provided patients have recovered from the radiation side-effects.
- •History of or radiological evidence of brain metastasis including previously treated, resected or asymptomatic brain lesions or leptomeningeal involvement.
- •Active seizure disorder or history of cerebrovascular accident (CVA) or transient ischemic (TI) attack within the past 12 months.
- •History of other malignancy within the last 3 years except for surgically cured non-melanoma skin cancer or cervical carcinoma in situ.
- •Active cardiac disease e.g. unstable angina, congestive heart failure, myocardial infarction (MI) within the preceding 6 months.
- •Any medical condition prohibiting standard imaging procedures
- •Pregnant or breast-feeding.
- •Any unrelated illness, e.g. active infection requiring parenteral antibiotics, inflammation, medical condition or laboratory abnormalities, which in the judgment of the investigator might significantly affect patients' study participation.
- •Any surgical or medical condition that might significantly alter the absorption, distribution, metabolism or excretion of either study drug.
- •Known hepatitis B/C or HIV (human immunodeficiency virus) infection.
研究组 & 干预措施
1
Experimental
Capecitabine, 1000 mg/m2, twice daily by mouth, on Days 1 to 14, followed by a 7 day rest in each 21 day cycle given in combination with WX-671 once daily by mouth, Days 1-21 inclusive.
干预措施: WX-671 (Drug)
2
Experimental
Capecitabine, 1000 mg/m2, twice daily by mouth, on Days 1 to 14, followed by a 7 day rest in each 21 day cycle given in combination with placebo once daily by mouth, Days 1-21 inclusive.
干预措施: placebo (Drug)
结局指标
主要结局
Efficacy in terms of progression-free survival (PFS)
时间窗: disease staging with CT/MRI/bone scans at regular intervals
次要结局
- Secondary endpoints are objective response rate (ORR), overall survival, safety and pharmacokinetics.(2 years)
研究者
研究点 (20)
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