EUCTR2011-000198-29-ES进行中（未招募）1 期
A Phase 1b/2 Randomized Study of MEDI-573 in Combination with an Aromatase Inhibitor (AI) Versus AI Alone in Women with Metastatic Breast Cancer (MBC)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 267
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
入选标准
- •Subjects must meet the following criteria:
- •Female gender and age ? 18 years at time of study entry
- •Women must be postmenopausal
- •Written informed consent and any locally-required authorization
- •Have histologically-confirmed metastatic breast cancer not deemed amenable to curative surgery or curative radiation therapy
- •Life expectancy of ? 6 months
- •Subjects must have adequate organ and marrow function
- •Suitable candidate for AI, including the ability to swallow and absorb oral agents
- •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 3
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •Any of the following would exclude the subject from participation in the study:
- •Concurrent enrollment in another clinical study testing an investigational agent or
- •intervention for cancer treatment or prevention
- •Subject directly involved with the conduct of the study or an immediate family
- •member of any such individual
- •Subjects who received prior chemotherapy, hormonal therapy, immunotherapy or
- •biologic therapy for advanced or metastatic disease (except Prior adjuvant therapy with an AI is allowed, provided treatment ended at least 1 year prior to the first dose of therapy; Prior treatment with tamoxifen is allowed, provided treatment ended at least; 1 week prior to the first dose of therapy; Prior neoadjuvant and/or adjuvant chemotherapy for breast cancer is allowed)
- •History of allergy or reaction attributed to compounds of chemical or biologic
- •composition similar to those of MEDI-573 or AI
- •Subject for whom endocrine therapy of breast cancer is not appropriate (ie,
- •life-threatening or rapidly progressing metastatic disease)
- •Subjects with extensive symptomatic visceral disease including hepatic
- •involvement and pulmonary lymphangitic spread of tumor, or disease that is
- •considered by the investigator to be rapidly progressing or life threatening (eg,
- •subjects who are intended for chemotherapy)
- •Known central nervous system metastases or leptomeningeal carcinomatosis
- •Evidence of spinal cord compression
- •Unresolved toxicities from prior therapy with the exception of alopecia that have not
- •resolved to ? Grade 1 (by National Cancer Institute Common Terminology Criteria
- •for Adverse Events [NCI CTCAE] version 4.0) at the time of starting study treatment
- •Receipt of any investigational therapy within 30 days or 5 half-lives, whichever is
- •longer, prior to receiving the first dose of study treatment
- •Previous treatment with agents that target the IGF receptor
- •Use of immunosuppressive medication other than steroids within 7 days before the
- •first dose of MEDI-573
- •History of another primary malignancy within 5 years prior to starting study treatment
- •except for curatively resected nonmelanoma skin cancer or carcinoma in situ of the
- •Poorly controlled diabetes mellitus as defined by investigator assessment and/or
- •hemoglobin A1c (HbA1c) > 8% within 21 days prior to randomization
- •History of cardiac disease including, but not limited to, congestive heart failure
- •> Class II New York Heart Association (see Appendix 3), active coronary artery
- •disease (eg, unstable angina pectoris), new onset angina pectoris, myocardial
- •infarction within the past 6 months, ventricular arrhythmias requiring antiarrhythmic
- •therapy, or uncontrolled hypertension within the last 6 months
- •Current active hepatic or biliary disease (with exception of subjects with Gilbert?s
- •syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease
- •per investigator assessment
研究者
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