EUCTR2006-003085-34-BE进行中（未招募）1 期
A Dose-escalating, Multicenter, Single arm, Open-label Study of XRP6258 in combination with capecitabine (Xeloda®), in patients with metastatic breast cancer with disease progressing after anthracycline and taxane therapy
sanofi-aventis recherche & developpement0 个研究点目标入组 50 人开始时间: 2006年9月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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. Histologically or cytologically proven diagnosis of breast adenocarcinoma that is now metastatic or locally recurrent and inoperable with curative intent. Patients with previously treated histo/cytologically confirmed disease who develop clinical or radiological evidence of metastatic disease do not require separate confirmation of the metastatic disease.
- •2. All patients must have received an anthracycline and a taxane prior to entry in the protocol. These drugs may have been given in the neoadjuvant/adjuvant or in the metastatic setting, may have been given concurrently or sequentially, and may have been given in combination with other drugs. Patients should have received a standard dose of anthracycline and of taxane expected to have potentially resulted in a response.
- •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
- •- The following breast cancer treatments:
- •a. Patients having received more than one adjuvant regimen. However, patients who have received neoadjuvant therapy immediately followed by surgery and immediately followed by adjuvant therapy without intervening progression are considered to have received one adjuvant regimen and are allowed in the trial.
- •b. Patients having received more than one chemotherapy regimen for metastatic or locally recurrent and inoperable breast cancer. A chemotherapy regimen is defined as a single or a combination of chemotherapy agents given until documented disease progression or relapse. For example, patients who received sequential doxorubicin and docetaxel in the metastatic setting without intervening progression are allowed in the trial as this is considered one CT regimen.
- •- ECOG performance status (PS)>2.
- •- Absence of measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST). For the part 1 component, patients with non-measurable disease are accepted.
- •- Known brain or leptomeningeal disease (CT or MRI scan of the brain required only in case of clinical suspicion of central nervous system involvement).
- •- Patients with known intolerance to fluoropyrimidines or patients with known dihydropyrimidine dehydrogenase (DPD) deficiency.
- •- Concurrent treatment with strong inhibitors of cytochrome P450 3A4 or patients planning to receive these treatments. For patients who were receiving treatment with such agents, a one-week washout period is required prior to registration.
- •- Any of the following within the 6 months prior to registration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft surgery, clinically symptomatic and uncontrolled cardiovascular disease, or clinically significant cardiac arrhythmias (grade 3-4).
研究者
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