EUCTR2015-003447-19-NO进行中（未招募）1 期
A Phase 3 Multicenter Open-label Study of Brigatinib(AP26113) versus Crizotinib in Patients with ALK-positiveAdvanced Lung Cancer
ARIAD Pharmaceuticals, Inc. (a wholly-owned subsidiary of Takeda Pharmaceutical Company Limited)0 个研究点目标入组 270 人开始时间: 2016年5月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 270
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
- •1. Have histologically or cytologically confirmed stage IIIB (locally advanced or recurrent and not a candidate for definitive multimodality therapy) or stage IV NSCLC.
- •2. Must have prior positive test results from an ALK test.
- •3. Have sufficient tumor tissue available for central analysis.
- •4. Have at least 1 measurable (i.e., target) lesion per RECIST v1.1.
- •5. Recovered from toxicities related to prior anticancer therapy to NCI CTCAE v 4.0 grade =1. Note: treatment-related alopecia or peripheral neuropathy that are grade >1 are allowed if deemed irreversible.
- •6. Are a male or female patient =18 years old.
- •7. Have adequate organ function, as defined by the study protocol.
- •8. Have Eastern Cooperative Oncology Group (ECOG) performance status <2.
- •9. Have normal QT interval on screening ECG evaluation, defined as QT interval corrected (Fridericia) (QTcF) of =450 milliseconds (msec) in males or =470 msec in females.
- •10. For female patients of childbearing potential, have a negative pregnancy test documented prior to randomization.
- •11.For female and male patients who are fertile, agree to use a highly effective form of contraception with their sexual partners during the dosing period and for a period of at least 4 months after the end of treatment with brigatinib and at least 3 months after the end of treatment with crizotinib.
- •12. Provide signed and dated informed consent indicating that the patient has been informed of all pertinent aspects of the study, including the potential risks, and is willingly participating.
- •13 Have the willingness and ability to comply with scheduled visit and study procedures.
- •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 216
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 54
排除标准
- •1. Previously received an investigational antineoplastic agent for NSCLC.
- •2. Previously received any prior TKI, including ALK-targeted TKIs.
- •3. Previously received more than 1 regimen of systemic anticancer therapy for locally advanced or metastatic disease.
- •4. Received chemotherapy or radiation within 14 days of first dose of study drug, except stereotactic radiosurgery (SRS) or stereotactic body radiation therapy (SBRT).
- •5. Received anti-neoplastic monoclonal antibodies within 30 days of the first dose of study drug.
- •6. Had major surgery within 30 days of the first dose of study drug, minor surgical procedures such as catheter placement or minimally invasive biopsies are allowed.
- •7. Have been diagnosed with another primary malignancy other than NSCLC, except for adequately treated non-melanoma skin cancer or cervical cancer in situ; definitively treated non-metastatic prostate cancer; or patients with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy.
- •8. Have symptomatic CNS metastases (parenchymal or leptomeningeal) at screening or asymptomatic disease requiring an increasing dose of corticosteroids to control symptoms within 7 days prior to randomization.
- •9. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression are allowed.
- •10. Be pregnant, planning a pregnancy, or breastfeeding
- •11. Have significant, uncontrolled, or active cardiovascular disease, as defined by the study protocol.
- •12. Have uncontrolled hypertension.
- •13. Have a history or the presence at baseline of pulmonary interstitial disease, drug-related pneumonitis, or radiation pneumonitis.
- •14. Have an ongoing or active infection.
- •15. Have a known history of human immunodeficiency virus (HIV) infection.
- •16. Have a known or suspected hypersensitivity to brigatinib or its excipients and/or crizotinib or its excipients.
- •17. Have malabsorption syndrome or other gastrointestinal (GI) illness or condition.
- •18. Have any condition or illness that, in the opinion of the investigator, would compromise patient safety or interfere with the evaluation of the study drug.
研究者
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