EUCTR2010-021067-32-CZ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
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
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.
- •- Patients must demonstrate no evidence of systemic disease and have an acceptable safety profile at the completion of the parent study or at the time of the parent study closure.
- •- Expectation by the investigator that the patient may continue to benefit from additional study treatment (i.e. single agent trastuzumab emtansine, combination trastuzumab emtansine with pertuzumab with or without paclitaxel, or control arm treatment given in BO21976/TDM4450g).
- •- For women of childbearing potential, agreement to use an effective form of contraception (patient and/or partner, e.g., surgical sterilization, a reliable barrier method, birth control pills, or contraceptive hormone implants) and to continue its use for the duration of the study treatment and for at least 7 months after the last dose of study treatment. 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 (V) 3.0 or V4.0, 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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