ISRCTN51253312进行中（未招募）1 期
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 人开始时间: 2016年6月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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
- •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
- •8.3. White Blood Cells >3 x 109/L
- •8.4. Platelet count > 100 x 109/L
- •8.5. Bilirubin < 1.5 x upper limit of normal (ULN)
- •8.6. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 2.5 x ULN
- •8.7. Adequate renal function with creatinine clearance / glomerular filtration rate > 50 ml/min calculated by Cockcroft-Gault/Wright formula
- •9. Able to commence radiotherapy treatment within 6 weeks (+ 1 week if necessary) of surgery
- •10. Willingness to comply with scheduled visits, treatment plans, laboratory tests and any other trial procedures
- •11. Ability to swallow oral tablets or capsules
- •12. Evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 7 days of trial entry
- •Postmenopausal is defined as:
- •12.1. Amenorrhoeic for 1 year or more following cessation of exogenous hormonal treatments
- •12.2. LH and FSH levels within the postmenopausal range for women under 50
- •12.3. Surgical sterilisation (bilateral oophrectomy or hysterectomy)
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
- •11. Any previous treatment with a PARP inhibitor, including olaparib
- •12. Any red blood cell transfusions within 28 days prior to trial entry (platelet and clotting factor transfusions are allowed)
- •13. Patients with myelodysplastic syndrome/acute myeloid leukaemia
- •14. Major surgery within 14 days of starting trial treatment; patients must have recovered from any effects of major surgery
- •15. Patients with a known hypersensitivity to any of the excipients of olaparib, temozolomide or dacarbazine (DTIC)
- •16. Patients with uncontrolled seizures
- •17.Patients who are known to be HIV positive, or who are known to have positive Hepatitis B or C serology
研究者
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