PARADIGM-2:OlaPArib and RADIotherapy or olaparib and radiotherapy plus temozolomide in newly-diagnosed Glioblastoma stratified by MGMT status: 2 parallel phase I studies

HS Greater Glasgow & Clyde and University of Glasgow0 个研究点目标入组 50 人2016年6月6日

适应症Glioblastoma Cancer

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: Glioblastoma
发起方: HS Greater Glasgow & Clyde and University of Glasgow
入组人数: 50
状态: 进行中（未招募）
最后更新: 5年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2016年6月6日

结束日期

2020年12月31日

最后更新

5年前

研究类型

Interventional

性别

All

研究者

发起方

HS Greater Glasgow & Clyde and University of Glasgow

入排标准

入选标准

•1\. Age\<70 years
•2\. Histologically confirmed diagnosis of glioblastoma (WHO grade 4, including variants)
•3\. WHO performance status 0 or 1
•4\. Sufficient tumour material for MGMT promoter methylation assay
•5\. Life expectancy greater than 12 weeks
•6\. No previous radiotherapy for primary or secondary CNS malignancy
•7\. Ability to provide informed consent prior to participating in the trial and any trial\-related procedures being performed
•8\. Adequate haematological, hepatic and renal function defined as below:
•8\.1\. Haemoglobin \> 100g/L (no red blood cell transfusions in the 28 days prior to trial entry)
•8\.2\. Absolute neutrophil count \>1\.5 x 109/L

排除标准

•1\. Age \=70
•2\. WHO performance status \>2
•3\. Life expectancy less than 12 weeks
•4\. Active concurrent malignancy (except non\-melanoma skin cancer or in\-situ carcinoma of the cervix). If history of prior malignancy, must be disease\-free for \>5 years
•5\. Prior treatment for primary or secondary CNS malignancies
•6\. Confusion or altered mental state that would prohibit patient understanding and giving of informed consent
•7\. Concomitant treatment with medicines detailed in section 5\.8 of PARADIGM\-2 protocol
•8\. Female patients who are able to become pregnant (or are already pregnant or lactating). Lactating patients should not breast feed during treatment or for 1 month after the last dose of olaparib. However, those female patients who have a negative serum or urine pregnancy test before enrolment and are not lactating and agree to the use of two highly effective forms of contraception (as detailed in section 7\.1\.7\) effective at the first administration of IMP, throughout the trial and for at least one month afterwards are considered eligible
•9\. Male partners of child\-bearing potential (unless they agree to take measures not to father children by using one form of highly effective contraception, as detailed in section 7\.1\.7, effective at the time of administration of IMP, throughout the trial and for six months afterwards). Men with pregnant or lactating partners should be advised to use barrier method contraception to prevent exposure to the foetus or neonate
•10\. Administration of any investigational drug within 28 days prior to receiving the first dose of trial treatment