EUCTR2010-021165-76-GB进行中（未招募）不适用
STOMP: Small cell lung cancer Trial of Olaparib (AZD2281) as Maintenance Programme: a randomised, double blind, multicentre phase II trial - STOMP: SCLC Trial of Olaparib (AZD2281) as Maintenance Programme.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 222
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
- •Pathologically confirmed SCLC (limited or extensive stage).
- •Completed at least 3 cycles of first line chemotherapy with cisplatin or carbopatin + etoposide.
- •Complete response or partial response to first line chemotherapy.
- •ECOG performance status 0-2.
- •Resolution of all treatment toxicity to grade 1 or better.
- •Adequate physiological function:
- •renal: calculated or measured creatinine clearance greater than or equal to 50 ml/min, serum creatinine less than or equal to 1.5 x institutional upper limit of normal (ULN)
- •haematological: Haemoglobin greater than or equal to 9.0 g/dL, White blood cells (WBC)greater than 3x109/L, ANC greater than or equal to 1.5 x 109/L, Platelet count greater than or equal to 100 x 109/L.
- •hepatic: AST (SGOT)/ALT (SGPT) less than or equal to 2.5 x institutional ULN unless liver metastases are present in which case it must be less than or equal to 5x ULN bilirubin within normal range, AST/ALT less than or equal to 1.5 x ULN.
- •Negative pregnancy test and agrees to comply with contraceptive measures.
- •Provision of written informed consent.
- •Able to swallow oral medication
- •Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Age greater than 18 years.
- •Interval from last anticancer treatment to start of study treatment:
- •- radiotherapy less than 21 days
- •- chemotherapy less than 42 days
- •Symptomatic brain metastases.
- •Interstitial lung disease.
- •Previous malignancies (except curatively treated non-melanoma skin cancer or
- •carcinoma in situ of the cervix or breast) within the past 3 years.
- •History of malabsorption or major gastrointestinal tract resection likely to affect study drug absorption.
- •Treatment with any investigational product during the last 14 days (or a longer period depending on the defined characteristics of the agents used)
- •Any previous treatment with a PARP inhibitor, including olaparib.
- •Patients receiving the following classes of inhibitors of CYP3A4:
- •Azole antifungals
- •Macrolide antibiotics
- •Protease inhibitors
- •Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.
- •Breast feeding women.
- •Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV).
- •Patients with known active hepatic disease (i.e., Hepatitis B or C).
- •Patients with a known hypersensitivity to olaparib or any of the excipients of the product.
- •Patients with uncontrolled seizures.
研究者
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