ISRCTN42518913已完成2 期
A randomised phase II trial of Olaparib maintenance versus placebo monotherapy in patients with chemosensitive advanced non-small cell lung cancer
Velindre NHS Trust (UK)0 个研究点目标入组 70 人开始时间: 2013年11月8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
- 70
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
- 性别
- All
入选标准
- •At registration:
- •1. Histological diagnosis of NSCLC. Histology can be either squamous or nonsquamous. The same block or 10 unstained slides must be available for translational research.
- •2. Stage IIIB or stage IV lung cancer, that is not amenable to curative therapy
- •3. Eastern Cooperative Oncology Group (ECOG) performance status 01
- •4. Have had no prior systemic treatment for lung cancer including previous adjuvant and neoadjuvant therapy. Patients who have already started their induction chemotherapy are not eligible.
- •5. Eligible to receive standard platinum doublet-based chemotherapy
- •6. Men or women, aged 18 or over and capable of giving informed consent
- •7. Willing to consent to provide tissue and blood for translational research
- •8. Informed consent prior to any study procedures.
- •At randomisation:
- •1. Partial or complete response to platinum containing doublet chemotherapy after a minimum of 3 cycles, as assessed by the local radiologist
- •2. Adequate organ function, including the following:
- •2.1. Adequate bone marrow reserve: absolute neutrophil count (ANC) = 1.5 x 10^9/L, platelets = 100 x 10^9/L , Haemoglobin of = 10g/dL
- •2.2. Hepatic: total bilirubin = 1.5 times the upper limit of normal (x ULN); alkaline phosphatase (ALP), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) = 2.5 x ULN. ALP, AST, and ALT = 5 x times ULN is acceptable if the liver has tumour involvement
- •2.3. Renal: calculated creatinine clearance (CrCl) = 50mL/min based on the original weight based Crockcroft and Gault formula, Serum creatinine = 1.5 x institutional upper limit of normal (ULN)
- •2.4. If blood count suggestive of MDS/AML, no features suggestive of MDS/AML on peripheral blood smear
- •3. Patients with reproductive potential must be prepared to use adequate contraception throughout the study and for three months after the last dose of Olaparib
- •4. Informed consent prior to any study specific procedures
- •Target Gender: Male & Female
排除标准
- •At registration:
- •1. Evidence of small cell, large cell neuroendocrine or carcinoid histology
- •2. Have a serious or uncontrolled medical condition that in the opinion of the investigator would compromise the patients ability to adhere to the protocol
- •3. Have a secondary malignancy (except adequately treated non-melanomatous skin cancer, or other cancer that is considered cured by surgical resection or radiation). Patients who had another malignancy in the past but have been disease free for more than 5 years, are eligible.
- •4. Have had a blood transfusion within 4 weeks prior to entry and have a WBC >3 x 10^9/L
- •5. Have central nervous system (CNS) metastases (unless the patient has completed successful local therapy for CNS metastases eg. Involving complete surgical removal or radical radiotherapy to a solitary CNS metastasis )
- •6. Are receiving concurrent administration of any other systemic antitumour therapy
- •7. Have received a recent (within 30 days of enrolment) or are receiving a concurrent yellow fever vaccination
- •8. Previous treatment with PARP inhibitors
- •9. Difficulty swallowing
- •10. Uncontrolled GI disorders such as active diverticulitis or colitis, or any major GI resection which could have an impact on patients' ability to absorb Olaparib
- •11. Patients with myelodysplastic syndrome/Acute myeloid leukaemia
- •12. Congenital long QT syndrome
- •At randomisation:
- •1. Patients with radiological disease progression or stable disease
- •2. Have received treatment with an agent that has not received regulatory approval, within 30 days of study entry
- •3. Have had a blood transfusion within 4 weeks prior to entry and have a WBC >3 x 10^9/L
- •4. Resting ECG with QTc>/480 msec
- •5. Are pregnant or breastfeeding
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