EUCTR2010-021067-32-PL进行中（未招募）1 期
An open-label, multicenter extension study of trastuzumab emtansine administered as a single agent or in combination with other anti-cancer therapies in patients previously enrolled in a Genentech and /or F. Hoffmann-La Roche Ltd. - sponsored trastuzumab emtansine study. - Extension study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 234
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 trastuzumab emtansine or combination
- •trastuzumab emtansine treatment in the parent study or who continue
- •to receive single-agent trastuzumab emtansine or combination
- •trastuzumab emtansine at the time of the parent study closure or
- •treatment in the control arm of study BO21976/TDM4450g at the time of
- •the study closure.
- •- Expectation by the investigator that the patient may continue to benefit
- •from additional study treatment.
- •- For women 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 during the
- •treatment period and for at least 5 months after the last dose of
- •atezolizumab (if applicable) or 7 months after the last dose of
- •trastuzumab emtansine or pertuzumab, whichever is later. For men,
- •agreement to use an effective form of contraception and to continue its
- •use for the duration of the study.
- •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 204
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •- Adverse events leading to single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment
- •discontinuation in the parent study.
- •- Ongoing serious adverse events from the parent study
- •- Progressive disease (except for isolated CNS progression) on single-agent trastuzumab emtansine or a trastuzumab emtansine-containing regimen during the 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. or 4.0 as utilized in the parent study
- •- History of symptomatic congestive heart failure ([CHF]; New York Heart Association [NYHA] Classes II-IV), ventricular arrhythmia requiring treatment, 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.
- •- 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 (i.e., chemotherapy, trastuzumab etc.) since the patient's last dose in the parent study.
- •- History of hypersensitivity with previous trastuzumab emtansine or any agent used with trastuzumab emtansine 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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