NCT02547675No Longer Available不适用
An Expanded Access Protocol of Oral Rociletinib (CO-1686) as Epidermal Growth Factor Receptor (EGFR)-Directed Therapy for Patients With EGFR-Mutant Non-Small Cell Lung Cancer (NSCLC) With the T790M Resistance Mutation
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 试验地点
- 11
研究概览
简要总结
To provide access to rociletinib for patients with advanced or metastatic EGFR-mutant NSCLC who have been treated previously with EGFR directed therapy and have evidence of a T790M mutation (T790M+).
详细描述
This is an open-label, multi-center study in the US, which allows for expanded access to rociletinib for patients with advanced or metastatic, EGFR-mutant T790M+ NSCLC who were previously treated with at least one prior EGFR TKI therapy (≥2nd line). Patients will receive oral rociletinib twice daily on study as long as they have clinical benefit and until they have access to FDA-approved rociletinib.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unresectable locally advanced or metastatic NSCLC with EGFR activating mutation (excluding exon 20 insertion) and presence of the T790M mutation
- •Prior treatment with an approved or experimental EGFR-directed therapy
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Adequate hematological and biological function
- •Written informed consent on an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved ICF before any study-specific evaluation
排除标准
- •Eligibility for other enrolling clinical trials of rociletinib
- •Leptomeningeal carcinomatosis or other untreated or symptomatic CNS metastases (asymptomatic CNS metastases allowed if clinically stable without requirement for steroid dose increase for at least 4 weeks)
- •History of prior interstitial lung disease
- •Concurrent use of QT-prolonging medication
- •Cardiac abnormalities:
- •Clinically significant abnormal 12-lead ECG, QT interval corrected using Fridericia's method (QTcF) > 450 ms
- •Inability to measure QT interval on ECG
- •Personal or family history of long QT syndrome
- •Implantable pacemaker or implantable cardioverter defibrillator
- •Resting bradycardia < 55 beats/min
- •Presence of serious or unstable concomitant systemic disorder incompatible with the clinical study (eg, substance abuse, uncontrolled intercurrent illness including active infection, arterial thrombosis, symptomatic pulmonary embolism, and other active malignancy associated with life expectancy of less than 1 year)
- •Pregnant or breastfeeding females and male or female patients who refuse to use adequate contraception during the study and for 12 weeks after the last dose of rociletinib
- •Any contraindication, allergy, or hypersensitivity to rociletinib or excipients
研究者
研究点 (11)
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