EUCTR2014-001216-19-GB进行中（未招募）1 期
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 人开始时间: 2014年9月8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
- 194
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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)
- •Absolute neutrophil count = 1.5 x 109/L
- •White Blood Cells =3x109/L
- •Platelet count = 100 x 109/L
- •Bilirubin = 1.5 x upper limit of normal (ULN)
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 2.5 x ULN
- •Adequate renal function with creatinine clearance / glomerular filtration rate > 50 ml/min. If the creatinine clearance / glomerular filtration rate is less than 50 ml/min as calculated by the Cockroft-Gault/Wright formula, then the creatinine clearance / glomerular filtration rate should be measured by either a radio-isotope technique or by 24-hour urine collection as per local practice
- •10. Ability to provide written informed consent prior to participating in the trial and any trial related procedures being performed
- •11. Willingness to comply with scheduled visits, treatment plans and laboratory tests and other trial procedures
- •12. Ability to swallow oral medications
- •13. Evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 7 days of trial entry
- •Post-menopausal is defined as:
- •Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments
- •LH and FSH levels in the post-menopausal range for women under 50
- •Or surgical sterilisation (bilateral oophorectomy or hysterectomy)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 174
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
- •11. Blood transfusions within 28 days prior to trial entry
- •12. Patients with myelodysplastic syndrome/acute myeloid leukaemia
- •13. Major surgery within 14 days of starting trial treatment and patients must have recovered from any effects of major surgery
- •14. Patients with a known hypersensitivity to olaparib or temozolomide or dacarbazine or any of the excipients of the product
- •15. Patients with uncontrolled seizures
- •16. Patients who are known to be HIV positive, or who are known to have positive Hepatitis B or C serology
- •17. Phase II only: Methylation of MGMT promoter region confirmed by central laboratory testing, or an inconclusive MGMT test result
- •18. Dose escalation substudy only: Unmethylation of MGMT promoter region confirmed by central laboratory testing, or an inconclusive MGMT test result
研究者
相似试验
已完成
1 期
Olaparib and radiotherapy In newly-diagnosed glioblastomaGliomasMalignant neoplasm of brainCancerISRCTN52658296HS Greater Glasgow and Clyde (UK)140
进行中（未招募）
1 期
Olaparib and radiotherapy or olaparib and radiotherapy plus temozolomide in newly-diagnosed glioblastoma stratified by MGMT statusGlioblastomaCancerISRCTN51253312HS Greater Glasgow & Clyde and University of Glasgow50
招募中
2 期
SCRT in TNT with or without chlorophylliCTRI/2023/04/051458Tata Memorial Hospital
进行中（未招募）
2 期
Radiation Therapy With or Without Olaparib in Treating Patients With Inflammatory Breast CancerBreast Inflammatory CarcinomaNCT03598257National Cancer Institute (NCI)300
已完成
1 期
A Study of Olaparib and Low Dose Radiotherapy for Small Cell Lung CancerSmall-cell Lung CancerSmall Cell Lung CarcinomaNCT03532880Memorial Sloan Kettering Cancer Center26