EUCTR2018-000365-37-GB进行中（未招募）1 期
A randomized, double-blind, placebo-controlled adjuvant trial in newly diagnosed primary glioblastoma subjects to assess the efficacy and safety of 2-hydroxyoleic acid (2-OHOA) in combination with radiotherapy and temozolomide standard of care treatment - ClinGlio
aminar Pharmaceuticals0 个研究点目标入组 234 人开始时间: 2019年6月27日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 234
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.Written informed consent, signed and dated
- •2.Subjects who are able to understand and follow instructions during the trial
- •3.Age =18 and =75
- •4.Subjects with newly histologically confirmed intracranial malignant glioma (glioblastoma WHO Grade IV) that is IDH1 wildtype (local assessment)
- •5.Ability to swallow and retain oral medication
- •6.Centrally obtained MGMT promoter methylation status
- •7.Subjects who underwent total or partial / incomplete resection and with the appropriate quantity of tumour tissue releasable for eligibility and signature assessments
- •8.Karnofsky Performance Score (KPS) > 40 %
- •9.Female subjects with a childbearing potential must have a negative pregnancy test within one week before inclusion in the trial. Those female and male subjects admitted in the study must use a reliable method of contraception.
- •Women must be:
- •Either of NOT childbearing potential: postmenopausal (= 60 years of age, or < 60 years of age and amenorrhoea for 12 months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression with follicle-stimulating hormone (FSH) above 40 U/L and oestradiol below 30 ng/L, or if taking tamoxifen or toremifene, and age < 60 years, then FSH and oestradiol in the postmenopausal range), permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy), or otherwise incapable of pregnancy
- •Or of childbearing potential and practicing a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies: e.g., established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device or intrauterine system; male partner sterilization (the vasectomized partner should be the sole partner for that subject).
- •10.A man who is sexually active and has not had a vasectomy must agree to use a barrier method of birth control e.g., either condom or partner with occlusive cap (diaphragm or cervical/vault caps).
- •11.Adequate bone marrow function including: Absolute neutrophil count (ANC) =1,500/mm3 or =1.5 x 109/L; Platelets = 100,000/mm3 or =100 x 109/L; Haemoglobin = 9 g/dL (may have been transfused).
- •12.Adequate hepatic function defined by a total bilirubin level = 1.5 × the upper limit of normal range (ULN), an aspartate aminotransferase (AST), level = 2.5 × ULN, and an alanine aminotransferase (ALT) level = 2.5 × ULN or, for subjects with documented metastatic disease to the liver, AST and ALT levels = 5 × ULN. Subjects with documented Gilbert disease are allowed if total bilirubin = 3 x ULN
- •13.Adequate renal function defined by an estimated creatinine clearance = 30 mL/min according to the Cockcroft-Gault formula
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 117
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 117
排除标准
- •1. Known hypersensitivity to any component of the investigational product.
- •2. Any other investigational drug within the preceding 30 days. Prior, concomitant, or planned concomitant treatment with anti-neoplastic aim including (but not limited) to NovoTumor Treatment Fields (Novo TTF), bevacizumab, intratumoural or intracavitary anti-neoplastic therapy (e.g Gliadel wafers), or other experimental therapeutics intended to treat the tumour.
- •3. Subjects who underwent only biopsy” resection
- •4. Anticancer therapy within 4 weeks of study entry (6 weeks for mitomycin and nitrosoureas)
- •5. Other major surgery within the preceding 30 days
- •6. Allergy, hypersensitivity or other intolerability to temozolomide and its excipients, patients with hypersensitivity to dacarbazine and patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
- •7. Unable to undergo MRI
- •8. Presenting with diffuse midline gliomas or multifocal GBM (distant from the flare or contralateral) or rapid progression between early post-surgery MRI and pre-radiotherapy MRI
- •9. Uncontrolled or significant cardiovascular disease
- •10. A history of uncontrolled hyperlipidaemia and/or the need for concurrent lipid lowering therapy
- •11. Need for warfarin, phenytoin or sulphonylureas (glibenclamide, glimepiride, glipizide, glyburide or nateglanide)
- •12. Past medical history of uncontrolled clinically significant active or chronic gastrointestinal disorders (for example, Crohn's disease, celiac disease, untreated stomach ulcers, etc) and gastro-inflammatory pathologies 13. Uncontrolled diabetes mellitus, with glycated haemoglobin (HbA1c) levels at the screening visit of =7.5%
- •14. Cardiac disease, defined specifically as either
- •a. Mean resting corrected QT interval (QTc) > 470 msec (for women) and > 450 ms (for men) obtained from 3 consecutive ECGs
- •b. Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (example, complete left bundle branch block, third degree heart block)
- •c. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, potential for Torsades de Pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age
- •15. Previous malignancies within the last three years other than ndGBM, except successfully treated squamous cell carcinoma of the skin, superficial bladder cancer, and in situ carcinoma of the cervix
- •Additional information regarding concomitant medications. Based on data in vitro, 2-OHOA is a potent inhibitor of CYP2C9. Subjects on warfarin, phenytoin and various oral hypoglycaemics are excluded (see above). Where concomitant use of other products metabolized by CYP2C9 is unavoidable, caution must be exercised and subjects should be closely monitored as appropriate.
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