EUCTR2007-002449-19-IT进行中（未招募）不适用
A phase Ib/IIa, trial of LBH589 in combination with trastuzumab in adult female patients with HER2 positive metastatic breast cancer whose disease has progressed during or following therapy with trastuzumab - ND
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 118
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
- •Inclusion Female patients ≥ 18 years old Patients with an ECOG performance status of ≤ 2 Histologically or cytologically confirmed breast cancer with radiological evidence of metastatic disease. During dose escalation metastatic disease can be non-measurable or measurable. During recruitment of the additional patients for dose expansion, only measurable disease is acceptable History of HER2-positive MBC patients (ICH 3+ staining or FISH (+ve) or ICH 2+ only if FISH (+ve). Whenever it is feasible HER2 status should be confirmed at metastatic stage of the disease at baseline and post-treatment Prior trastuzumab-containing regimen (in neoadjuvant and/or adjuvant and/or metastatic setting) regardless of whether trastuzumab was given as monotherapy or in combination with chemotherapy. Any number of prior trastuzumab regimens is acceptable Radiological evidence of progression while on trastuzumab or within 6 months of last dose of trastuzumab Radiological evidence of progression on or following most recent therapy within three month of study entry Up to 2 prior chemotheraphy regimens for treatment of MBC (including chemotherapy treatment in combination with trastuzumab) Patients must meet the following laboratory criteria: pls see protocol
- •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
- •Exclusion Prior HDAC, DAC, HSP90 inhibitors or valproic acid for the treatment of cancer Patients who need valproic acid for any other medical condition during the study or within 5 days prior to first LBH589 treatment Patients who have received prior chemotherapy within the last 4 weeks (6 weeks for nitrosoureas and mitomycin: 2 weeks for capecitabine) Patients who have received prior radiotherapy within the last 4 weeks Patients who have received prior investigational agents within the last 4 weeks Patients who have received prior radiotherapy to ≥30% of the bone marrow Patients with unresolved diarrhea ≥CTCAE grade 1 Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LBH589 Impaired cardiac function, including any one of the following: LVEF < 50% as determined by ECHO or MUGA Complete left bundle branch block or obligate use of a cardiac pacemaker or congenital long QT syndrome or history or presence of ventricular tachyarrhythmias or clinically significant resting bradycardia (<50 beats per minute) or QTc > 450 msec on screening ECG or right bundle branch block and left anterior hemiblock (bifasicular block) Presence of unstable atrial fibrillation (ventricular response rate >100 bpm). pls see protocol
研究者
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