EUCTR2010-021067-32-IT进行中（未招募）1 期
AN OPEN LABEL, MULTICENTER EXTENSION STUDY OF TRASTUZUMAB-MCC-DM1 (T-DM1) ADMINISTERED AS A SINGLE AGENT OR IN COMBINATION WITH OTHER ANTI CANCER THERAPIES IN PATIENTS PREVIOUSLY TREATED WITH THE EQUIVALENT T-DM1 REGIMEN IN A GENENTECH AND/OR F. HOFFMANN-LA ROCHE LTD.–SPONSORED T-DM1 STUDY - T-DM1 Extension study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- ROCHE
- 入组人数
- 100
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
- •- Completed single-agent T-DM1 or combination T-DM1 treatment on the parent study or who continue to receive single-agent T-DM1 or combination T-DM1 treatment at the time of the parent study closure and received the last study drug dose within the 6 weeks prior to the first scheduled dose of study therapy on the extension study; - Expectation by the investigator that the patient may continue to benefit from additional single-agent T-DM1 or combination T-DM1 treatment; - Women of childbearing potential and men with partners of childbearing potential, must be willing to use a highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception by the patient and/or partner, and to continue the use of contraception for the duration of study treatment and for at least 6 months after the last dose of study treatment. Male patients whose partners are pregnant should use condoms for the duration of the pregnancy.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •-Adverse events leading to single-agent T-DM1 or combination T-DM1 treatment discontinuation in the parent study; -Ongoing serious adverse events from the parent study; -Progressive disease (except for isolated brain metastases under certain conditions as described in Section 3.1) on single-agent T-DM1 or a T-DM1-containing regimen during parent study or before starting the extension study; -Peripheral neuropathy of Grade = 3 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0;
- •-History of symptomatic congestive heart failure ([CHF]; New York Heart
- •Association [NYHA] Classes II-IV), ventricular arrhythmia requiring treatment,current unstable angina, or history of myocardial infarction within 6 months prior to study entry;
- •-Severe dyspnea at rest due to complications of advanced malignancy
- •or current requirement for continuous oxygen therapy;
- •-Current severe, uncontrolled systemic disease (e.g., clinically significant
- •cardiovascular, pulmonary, or metabolic disease);
- •-Major surgical procedure or significant traumatic injury within 28 days prior to study entry or anticipation of the need for major surgery during the course of study treatment;
- •-Current pregnancy or lactation;
- •-History of receiving any investigational treatment or other systemic therapy directed at controlling cancer (e.g.,chemotherapy, Herceptin, etc.) since the patient’s last study drug dose in the parent study;
- •-History of hypersensitivity with previous T-DM1 or any agent used with T-DM1 in the parent study, precluding further dosing;
- •-Assessed by the investigator to be unable or unwilling to comply with
- •the requirements of the protocol.
研究者
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