EUCTR2015-000814-23-IT进行中（未招募）1 期
A Phase II, open label, multi-center, multi-arm study of ceritinib in patients with advanced solid tumors and hematological malignancies characterized by genetic abnormalities of anaplastic lymphoma kinase (ALK) -
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
- 22
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
- •- Written informed consent for the main study obtained prior to any screening procedure.
- •- Patient must have a histologically or cytologically confirmed diagnosis of one of the tumors that is ALK positive (ALK+). The ALK test results must be available at the investigator site before the first dose of the study drug. The tumor types are described below:
- •Anaplastic Large Cell Lymphoma (ALCL), local confirmation of diagnosis of ALK+ ALCL is sufficient for eligibility.
- •Inflammatory Myofibroblastic Tumor locally documented translocation involving the ALK gene,
- •Glioblastoma, Inflammatory breast cancer Any other locally documented ALK+ tumor. Must carry a locally documented genetic alteration of ALK including any of the following (ALK overexpression is also acceptable in Gliobalstoma):
- •?- A known activating mutation in the kinase domain of ALK or a point mutation in the kinase domain of ALK that results in an amino acid change that has not been reported in normal germline DNA, or any other mutation (e.g. insertion or deletion) which results in a change in the amino acid sequence of the kinase domain of ALK, as long as the alteration does not clearly result in inactivation of the kinase activity, such as deletion of the kinase domain, or a stop codon preventing translation of the kinase
- •?- An amplification of the ALK gene, defined as = 6 copies per cell, or 3 copies per haploid genome. When assessed by FISH, ALK amplification must be observed in focal clusters of tumor cells (not only single cells) or in more than one-third of the tumor cells.
- •? - A translocation involving the ALK gene.
- •?- Glioblastoma patients only, overexpression of ALK protein documented locally is also acceptable for eligibility
- •- Patient must provide an archival or fresh tumor tissue before the first dose of the study drug for potential retrospective ALK testing at a Novartis designated central laboratory by a comparative technology: the confirmation of ALK positivity is not required for enrollment if other inclusion and exclusion criteria are fulfilled
- •- Patient is 18 years or older at the time of informed consent.
- •- Patient has WHO performance status = 2.
- •- Patient has at least one measurable lesion as defined by appropriate guidelines. A lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation
- •Other protocol related inclusion criteria may apply
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •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 31
排除标准
- •1. Patient with ALK+ lung cancer.
- •2. Patient with known hypersensitivity to any of the excipients of LDK378.
- •3. Patient with symptomatic CNS metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms.
- •4. History of carcinomatous meningitis.
- •5. Patient with diarrhea CTCAE = grade 2; or patients with neuropathy CTCAE = grade 2
- •Other protocol related exclusion criteria may apply.
研究者
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