EUCTR2008-002721-37-DE进行中（未招募）不适用
An open-label, uncontrolled phase II trial of HDAC inhibitor LBH589 in patients with chemo-refractory metastatic gastric cancer overexpressing histone deacetylases - CLBH589BDE03T - HDAC-GaCa-2008
Medizinische Fakultät der TU-München, vertreten durch den Dekan0 个研究点目标入组 28 人开始时间: 2009年2月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 28
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
- •- Histologically proven adenocarcinoma of stomach, esophagogastric junction or lower esophagus (Barrett carcinoma)
- •- Measurable metastatic disease according to the RECIST (33).
- •- Overexpression of at least one class I HDAC in the cancer biopsy as assessed by immunohistochemistry.
- •- Failure of prior palliative chemotherapy/chemotherapies
- •- At least 4 weeks from previous chemotherapy at first dose of trial drug
- •- Resolution of all acute toxic side effects of prior therapy or surgical procedures to grade = 1 NCI-CTC
- •- Adequate organ function as defined by the following criteria
- •- At least 4 weeks from any major surgery (at first dose of trial drug)
- •- Karnofsky Performance Status (KPS) > 70
- •- Life expectancy > 12 weeks
- •- Patients who understand the nature of the trial and are willing and able to comply with scheduled visits, treatment plans, laboratory tests and other trial procedures
- •- Female patients who are capable of bearing children must have a negative pregnancy test result
- •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
- •- Other tumor type than adenocarcinoma (e.g., leiomyosarcoma, lymphoma) or a second cancer except in patients with squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix which has been effectively treated. Patients curatively treated and disease free for at least 5 years will be discussed with the sponsor before inclusion
- •- Patients with known brain or leptomeningeal metastasis
- •- Intake of non-permitted concomitant drugs (the coordinating investigator should be contacted to discuss the individual case), see chapter 5.4 in the protocol:
- •- Any prior radiotherapy of target lesions
- •- Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection (> hemicolectomy or extensive small intestine resection with chronic diarrhea), Crohn's disease, ulcerative colitis
- •- Current history of chronic diarrhea and/or diarrhea
- •- Active disseminated intravascular coagulation, or patients prone to thromboembolism
- •- Known human immunodeficiency virus (HIV) infection
- •- Active uncontrolled infection
- •- Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with trial participation or trial drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into the trial
- •- Known allergic/hypersensitivity reaction to any of the components of the treatment; or known drug abuse/alcohol abuse
- •- Impaired cardiac function or clinically significant cardiac diseases (see protocol)
- •- Patients who have received steroids (e.g. dexamethasone) = 2 weeks prior to starting study treatment or who have not recovered from side effects of such therapy. Concomitant therapy medications that include corticosteroids are allowed if patients receive < 10 mg of prednisone or equivalent as indicated for other medical conditions, or up to 100 mg of hydrocortisone as pre-medication for administration of certain medications or blood products while enrolled in this study.
研究者
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