ISRCTN73164486已完成2 期
Small cell lung cancer Trial of Olaparib (AZD2281) as Maintenance Programme: a randomised, double blind, multicentre phase II trial
Sheffield Teaching Hospitals NHS Foundation Trust (UK)0 个研究点目标入组 220 人开始时间: 2010年9月13日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 220
研究概览
简要总结
2017 Abstract results in https://doi.org/10.1016/j.jtho.2016.11.926 abstract (added 23/01/2019) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35872530/ (added 26/07/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 23/01/2019:
- •1. Pathologically confirmed SCLC (limited or extensive stage)
- •2. Completed at least 3 cycles of first line chemotherapy or chemo-radiotherapy with cisplatin + etoposide or carboplatin + etoposide
- •3. Complete Response (CR) or Partial Response (PR) to first line chemotherapy (RECIST criteria)
- •4. ECOG performance status 0-2
- •5. Resolution of all treatment toxicity to grade 1 or better
- •6. Adequate physiological function:
- •6.1. Renal:
- •6.1.1. Calculated or measured creatinine clearance = 50 ml/min
- •6.1.2. Serum creatinine = 1.5 x institutional upper limit of normal (ULN)
- •6.2. Haematological:
- •6.2.1. Haemoglobin = 9.0 g/dL
- •6.2.2. White blood cells (WBC) = 3x109/L
- •6.2.3. Absolute Neutrophil Count (ANC) = 1.5 x 109/L
- •6.2.4. Platelet count = 100 x 109/L
- •6.2.5. International Normalized Ratio (INR) = 1.2
- •6.3. Hepatic:
- •6.3.1. Aspartate Aminoransferase (AST)/ Alanine Aminotransferase (ALT) = 2.5 x institutional ULN unless liver metastases are present in which case it must be = 5x ULN
- •6.3.2. Bilirubin within normal range
- •7. Negative pregnancy test and agrees to comply with contraceptive measures
- •8. Provision of written informed consent
- •9. Able to swallow oral medication
- •10. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations
- •Previous inclusion criteria:
- •1. Pathologically confirmed SCLC (limited or extensive stage)
- •2. Completed at least 3 cycles of first line chemotherapy with cisplatin or carbopatin + etoposide
- •3. Complete Response (CR) or Partial Response (PR) to first line chemotherapy (RECIST criteria)
- •4. ECOG performance status 0-2
- •5. Resolution of all treatment toxicity to grade 1 or better
- •6. Adequate physiological function:
- •6.1. Renal:
- •6.1.1. Calculated or measured creatinine clearance = 50 ml/min
- •6.1.2. Serum creatinine = 1.5 x institutional upper limit of normal (ULN)
- •6.2. Haematological:
- •6.2.1. Haemoglobin = 9.0 g/dL
- •6.2.2. White blood cells (WBC) = 3x109/L
- •6.2.3. Absolute Neutrophil Count (ANC) = 1.5 x 109/L
- •6.2.4. Platelet count = 100 x 109/L
- •6.2.5. International Normalized Ratio (INR) = 1.2
- •6.3. Hepatic:
- •6.3.1. Aspartate Aminoransferase (AST)/ Alanine Aminotransferase (ALT) = 2.5 x institutional ULN unless liver metastases are present in which case it must be = 5x ULN
- •6.3.2. Bilirubin within normal range
- •7. Negative pregnancy test and agrees to comply with contraceptive measures
- •8. Provision of written informed consent
- •9. Able to swallow oral medication
- •10. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations
排除标准
- •Current exclusion criteria as of 23/01/2019:
- •1. Age =18 years
- •2. Interval from last anticancer treatment to start of study treatment:
- •2.1. Radiotherapy = 21 days
- •2.2. Chemotherapy = 42 days
- •3. Symptomatic brain metastases
- •4. Interstitial lung disease
- •5. Previous malignancies (except curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix or breast) within the past 3 years
- •6. History of malabsorption or major gastrointestinal tract resection likely to affect study drug absorption.
- •7. Treatment with any investigational product during the last 14 days (or a longer period depending on the defined characteristics of the agents used)
- •8. Any previous treatment with a PARP inhibitor, including Olaparib
- •9. Patients receiving the following classes of inhibitors of CYP3A4; Azole antifungals; Macrolide antibioticsProtease inhibitors
- •10. 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.
- •11. Breast feeding women
- •12. Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV)
- •13. Patients with known active hepatic disease (i.e., Hepatitis B or C)
- •14. Patients with a known hypersensitivity to Olaparib or any of the excipients of the product
- •15. Patients with uncontrolled seizures
- •16. Patients with myelodysplastic syndrome (MDS) / acute myeloid leukaemia (AML)
- •17. Major surgery within 14 days of starting trial treatment and patients must have recovered from any effects of any major surgery
- •Previous exclusion criteria:
- •1. Age =18 years
- •2. Interval from last anticancer treatment to start of study treatment:
- •2.1. Radiotherapy = 21 days
- •2.2. Chemotherapy = 42 days
- •3. Symptomatic brain metastases
- •4. Active infection on day of enrollment
- •5. Interstitial lung disease
- •6. Previous malignancies (except curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix or breast) within the past 3 years
- •7. History of malabsorption or major gastrointestinal tract resection likely to affect study drug absorption.
- •8. Treatment with any investigational product during the last 14 days (or a longer period depending on the defined characteristics of the agents used)
- •9. Any previous treatment with a PARP inhibitor, including Olaparib
- •10. Patients receiving the following classes of inhibitors of CYP3A4; Azole antifungals; Macrolide antibioticsProtease inhibitors
- •11. 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
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