EUCTR2013-005014-34-IT进行中（未招募）不适用
A phase II, single arm, open-label, multicenter, study of oral LGX818 in patients with BRAF V600 mutant advanced non-small cell lung cancer that have progressed during or after at least one prior chemotherapy - Not available
OVARTIS FARMA S.p.A.0 个研究点目标入组 58 人开始时间: 2014年4月16日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 58
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
- •- Male or female patients, age = 18 years
- •- Presence of BRAF V600E mutation in tumor tissue prior to study treatment, as determined by the specified investigational diagnostic test at a Novartis designated central laboratory
- •- Histologically or cytologically confirmed diagnosis of Stage IIIB or IV NSCLC
- •- At least one measurable lesion as defined by RECIST v1.1. A previously irradiated site lesion may only be counted as a target lesion if there is clear sign of progression since the irradiation
- •- Patients must have progressed during or after at least one previous systemic, anti-cancer treatment for locally advanced or metastatic NSCLC.
- •Prior cytotoxic chemotherapy must include a platinum doublet.
- •(Neo-)adjuvant cytotoxic chemotherapy counts as one prior line of treatment if relapse occurred within 12 months from the end of the (neo-)adjuvant cytotoxic chemotherapy.
- •- ECOG/World Health Organization (WHO) performance status 0-2
- •Other protocol-defined inclusion criteria may apply
- •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 19
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 39
排除标准
- •- Patients with symptomatic CNS metastases (neurologically unstable or required increasing doses of steroids within the 2 weeks prior to study entry)
- •- History of leptomeningeal metastases (carcinomatous meningitis)
- •- Prior therapy with a BRAF inhibitor
- •- Patients who have received thoracic radiotherapy to lung fields = 4 weeks prior to starting the study treatment or patients who have not recovered from radiotherapy-related toxicities. For all other anatomic sites (including radiotherapy to thoracic vertebrae and ribs) radiotherapy = 2 weeks prior to starting the study treatment or who have not recovered from radiotherapy-related toxicities. Palliative radiotherapy for bone lesions = 2 weeks prior to starting study treatment is allowed
- •- Patients taking non-topical medication known to be a strong inhibitor of CYP3A4.However patients who either discontinue their treatment or switch to another medication at least three days prior to the first administration of LGX818 are eligible.
- •- Patients who underwent major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) within 4 weeks prior (2 weeks for resection of brain metastases) to starting study drug or who have not recovered from side effects of such procedures. Video-assisted thoracic surgery (VATS) and mediastinoscopy will not be counted as major surgery, and patients can be enrolled in the study = 1 week after the procedure
- •- Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years. Exceptions to this exclusion include the following: completely resected basal cell and squamous cell skin cancers, and completely resected carcinoma in situ of any type
- •- Impaired cardiovascular function or clinically significant cardiovascular diseases
- •- Uncontrolled arterial hypertension despite medical treatment
- •- Patient is receiving unstable or increasing doses of corticosteroids. If patients are on corticosteroids for endocrine deficiencies or tumor-associated symptoms (non-CNS), dose must have been stabilized (or decreasing) for at least 5 days before first dose of study treatment
- •Other protocol-defined exclusion criteria may apply
研究者
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