EUCTR2008-006055-52-DE进行中（未招募）1 期
Everolimus (RAD001) in combination with intravenous carboplatin in taxane- and anthracycline-pretreated patients with progressive metastatic breast cancer - RAD001 and carboplatin in pretreated metastatic breast cancer
Charité - University Hospital of Berlin0 个研究点目标入组 58 人开始时间: 2008年11月17日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 58
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
- •Adult, female patients (= 18 years old)
- •Histologically or cytologically proven breast cancer that is now progressive (metastatic or locally recurrent) and inoperable.
- •At least two prior chemotherapy regimens due to metastatic or inoperable breast cancer.
- •Pretreatment with at least one taxane and one anthracycline (separated or combined) in an adjuvant or metastatic setting.
- •Completion of all prior chemotherapy, immunotherapy, targeted non-cytotoxic therapy and radiotherapy two weeks prior to first dose on study. Concomitant treatment with bisphosphonates is possible.
- •Karnofsky performance status of al least 60%
- •Signed written informed consent according to ICH/EU GCP and national/local regulations
- •Infertility or acceptable method of contraception (PEARL - Index < 1%)
- •o Completion of one or more of the following criteria:
- •- female of non-childbearing potential: hysterectomy, bilateral oophorectomy, bilateral tube ligation, post-menopausal = 2 years
- •- female with acceptable contraception: complete abstinence of intercourse, intrauterine device, two forms of barriers contraception, male partner is sterile and the only partner of the female
- •Subject is able to understand and comply with the protocol requirements and instructions and intends to complete the study as planned
- •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
- •Known hypersensitivity against everolismus or sirolimus (rapamycin), carboplatin, or lactose.
- •Previous treatment with cisplatin, carboplatin, or oxaliplatin.
- •Previous treatment with RAD001 (Everolimus) or other mTOR-inhibitors
- •HER2-positive patients who are candidates for trastuzumab
- •Known uncontrolled metastases in CNS or Meningeosis carcinomatosa.
- •Prevalence of a hypercholesterinemia/hypertriglyceridemia (> CTC grade 3).
- •Uncontrolled infection.
- •Serious cardiac disease (uncontrolled arrhythmias, unstable angina, severe congestive heart failure).
- •Serious pulmonary, neurological, endocrinological or other disorder interfering with study medication, especially patients with known lung fibrosis, emphysema, or severe COPD.
- •Bleeding tumor
- •Serious depression that needed therapy within the last 5 years.
- •Missing willingness or ability to comply with scheduled visits, treatment plans, laboratory tests, or other study procedures
- •Concomitant or previous malignancies other than basal cell or squamous cell skin cancer, in situ cervical cancer and other cancer for which the patient has been disease-free for at least 5 years.
- •Unresolved hepatitis B or C infection or known HIV positive infection.
- •Inadequate organ function including bone marrow function (WBC = 2.5 x 109/L, ANC = 1.5 x 109/L, Platelets = 80 x 109/L, or Hb = 8 g/dL), liver function (total bilirubin > 1.0 x ULN > 1.5 x ULN, albumin = 3g/dl, serum transaminase activity = 2.5 x ULN or = 5.0 x ULN if the elevation is due to hepatic metastasis, alkaline Phosphatase = 2.5 x ULN or 5.0 if the elevation is due to hepatic metastasis), renal function (creatinine = 2 x ULN)
- •Patients who received any other investigation drugs within 30 days prior study enrolment
- •Patients who have been treated during the last five days with inhibitors or inducers the isoenzyms CYP3A (e.g. rifabutin, rifampicin, clarithromycin, ketoconazol, itroconazol, voriconazol, ritinavir, telithromycin).
- •Women who are pregnant or breast feeding, or women of childbearing potential without highly effective contraception (PEARL-Index < 1%) (women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to study enrolment). Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study.
- •Persons who are detained officially or legally to an official institute according AMG § 40
研究者
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