CTRI/2014/12/005250已完成3 期
An open-label, multi-center, Expanded Treatment Protocol(ETP) of oral LDK378 in adult patients with non-small celllung cancer (NSCLC) characterized by ALK positivity - Expanded Treatment Protocol
ovartis Healthcare Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Histologically or cytologically confirmed diagnosis of NSCLC that demonstrates ALK positivity as assessed by approved FISH test (Abbott Molecular Inc), using Vysis break apart probes (defined as 15% or more positive tumor cells); or the Ventana IHC test. If documentation of ALK positivity is not available, the test to confirm ALK positivity must be performed according to the above criterion, using a new tumor biopsy obtained prior to the first dose of ETP treatment (LDK378).
- •Stage IIIB or IV NSCLC patient with documented disease progression at enrollment, and who does not qualify or have access to LDK378 through a clinical trial.
- •Patients who have been pre-treated with an ALK inhibitor for locally advanced or metastatic NSCLC.
- •Patient is 18 years of age or older at the time of informed consent
- •Life expectancy >= 12 weeks
- •WHO performance status 0-3
- •Patients must have recovered from all toxicities related to prior anticancer therapies to <= grade 2 (CTCAE v 4.03),
- •The following laboratory criteria have been met:
- •Absolute neutrophil count (ANC) >= 1.5 x 109/L
- •Hemoglobin (Hgb) >= 8 g/dL
- •Platelets >= 75 x 109/L
- •Serum total bilirubin <= 1.5 x upper limit of normal (ULN), except for patients with
- •Gilbertâ??s syndrome who may be included if total bilirubin <= 3.0 x ULN and direct bilirubin <= 1.5 x ULN
- •Aspartate transaminase (AST) < 3.0 x ULN, except for patients with liver metastasis, who are only included if AST < 5 x ULN; alanine transaminase (ALT) < 3.0 x ULN, except for patients with liver metastasis, who are only included if ALT < 5 x ULN
- •Calculated or measured creatinine clearance (CrCL) >= 30 mL/min
- •Magnesium >= LLN
- •Phosphorus >= LLN
- •Total calcium (corrected for serum albumin) >= LLN
排除标准
- •Patients with symptomatic CNS metastases who are neurologically unstable or have required increasing doses of steroids within the 1 week prior to ETP entry to manage CNS symptoms
- •The patient is less than 5 half-lives from prior ALK inhibitor or targeted therapy (for adequate wash-out) without recovery from treatment toxicities to grade 1 or to their pretreatment levels.
- •Patient who has 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 has not recovered from radiotherapy-related toxicities. Palliative radiotherapy for bone lesions <= 2 weeks prior to starting study treatment is allowed.
- •Patient has had 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 treatment or has not recovered from side effects of such procedure. Video-assisted thoracic surgery (VATS) and mediastinoscopy will not be counted as major surgery and patients can receive study treatment >=1 week after the procedure.
- •Patient with a concurrent malignancy or history of a malignant disease other than NSCLC 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.
- •Patient has clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months), such as:
- •Unstable angina within 6 months prior to screening
- •Myocardial infarction within 6 months prior to screening
- •History of documented congestive heart failure (New York Heart Association functional classification III-IV)
- •Uncontrolled hypertension defined by a Systolic Blood Pressure (SBP) >= 160 mm Hg and/or Diastolic Blood Pressure (DBP) >= 100 mm Hg, with or without anti-hypertensive medication. Initiation or adjustment of antihypertensive medication (s) is allowed prior to screening
- •Ventricular arrhythmias
- •Corrected QT (QTcF) 470 ms using Fridericiaâ??s correction on the screening ECG (as mean of triplicate ECGs)
- •Patient has impairment of GI function or GI disease that may significantly alter the absorption of LDK378 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome).
- •Patient receiving treatment with medications that meet one of the following criteria and that cannot be discontinued at least 1 week prior to the start of treatment with LDK378 and for the duration of the study:
- •Strong inhibitors or strong inducers of CYP3A4/5
- •Medications with a known risk of prolonging the QT interval or inducing Torsades de Pointes
- •Patient is currently receiving treatment with warfarin sodium (Coumadin®) or any other coumarin-derivative anticoagulants.
- •Patient is receiving treatment with any enzyme-inducing anticonvulsant that cannot be discontinued at least 1 week before first dose of study treatment, and for the duration of the study. Patient on non enzyme-inducing anticonvulsants is eligible.
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