Short-course radiotherapy plus olaparib for newly diagnosed glioblastoma in patients unsuitable for radical chemoradiation: a randomised phase II clinical trial preceded by a lead-in phase I dose escalation study. - PARADIGM: Olaparib And Radiotherapy In newly-diagnosed Glioblastoma

HS Greater Glasgow & Clyde0 个研究点目标入组 194 人2014年9月8日

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: 未指定
发起方: HS Greater Glasgow & Clyde
入组人数: 194
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

2014年9月8日

结束日期

待定

最后更新

5年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

HS Greater Glasgow & Clyde

入排标准

入选标准

•1\. Age \=70: WHO performance status 0 or 1 at initial oncology consultation
•2\. Phase I only: Age 18 – 69: WHO performance status 2 at initial oncology consultation or performance status 0\-1 but otherwise unsuitable for radical radiotherapy with concomitant and adjuvant temozolomide
•3\. Phase II and dose escalation substudy only:Age 65\- 69; WHO performance status 0, 1 or 2 at initial oncology consultation and unsuitable for radical radiotherapy with concomitant and adjuvant temozolomide
•4\. Phase II and dose escalation substudy only: Age 18\- 64; WHO performance status 2 at initial oncology consultation or performance status 0\-1 but otherwise unsuitable for radical radiotherapy with concomitant and adjuvant temozolomide
•5\. Histologically confirmed diagnosis of glioblastoma
•6\. Phase II and dose escalation substudy only; Sufficient tumour material for MGMT promoter methylation assay
•7\. Life expectancy greater than 12 weeks
•8\. No previous radiotherapy or chemotherapy for primary or secondary CNS malignancy
•9\. Adequate haematological, hepatic and renal function defined as below:
•Haemoglobin \= 100 g/L (no blood transfusions in the 28 days prior to trial entry)

排除标准

•1\. WHO performance status \>2
•2\. Life expectancy less than 12 weeks
•3\. 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
•4\. Prior treatment for primary or secondary CNS malignancy
•5\. Confusion or altered mental state that would prohibit understanding and giving of informed consent
•6\. Concomitant treatment with medicines listed as 'prohibited' or 'excluded' in section 5\.10 of protocol
•7\. Female patients who are able to become pregnant (or already pregnant or lactating). However, those female patients who have a negative serum or urine pregnancy test before enrolment and agree to use two highly effective forms of contraception detailed in section 7\.1\.12, effective at the first administration of olaparib, throughout the trial, and for at least one month afterwards, are considered eligible
•8\. Male patients with partners of child\-bearing potential (unless they agree to take measures not to father children by using one form of highly effective contraception detailed in section 7\.1\.12, effective at the first administration of IMP, throughout the trial, and for three months afterwards or 6 months if receiving temozolomide). Men with pregnant or lactating partners should be advised to use barrier method contraception to prevent exposure to the foetus or neonate. Female partners (of childbearing potential) of male patients should also use a highly effective form of contraception as detailed in section 7\.1\.12
•9\. Administration of any investigational drug within 28 days prior to receiving the first dose of trial treatment
•10\. Any previous treatment with a PARP inhibitor, including olaparib