2024-511542-39-00招募中3 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.
Laminar Pharmaceuticals S.A.16 个研究点 分布在 3 个国家目标入组 106 人开始时间: 2024年3月15日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 106
- 试验地点
- 16
- 主要终点
- • PFS according to RANO criteria evaluated after at least 66 PFS events occur. Occurrence of disease progression to calculate PFS will be determined first by the investigator based on local evaluation of images and other clinical information. Progression will be confirmed by an adjudication/imaging committee. • Overall Survival evaluated after at least 90 OS events are observed.
研究概览
简要总结
To evaluate the efficacy of 2-OHOA in combination with the standard of care (SoC) treatment of radiotherapy (RT) and TMZ, as assessed by: • Progression Free Survival (PFS) using the Response Assessment in Neuro-Oncology (RANO) criteria. • Overall Survival (OS). The detection of a large range of treatment effect (through sample size re-estimation) is primary objectives integrated in the adaptive design of the study.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Written informed consent, signed and dated
- •Subjects who are able to understand and follow instructions during the trial
- •Age ≥18 and ≤75
- •Subjects with newly histologically confirmed intracranial malignant glioma (glioblastoma WHO Grade IV) that is IDH1 wildtype (local assessment)
- •Ability to swallow and retain oral medication
- •Centrally obtained MGMT promoter methylation status
- •Subjects who underwent total or partial / incomplete resection and with the appropriate quantity of tumour tissue releasable for eligibility.
- •Karnofsky Performance Score (KPS) > 50 %
- •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, for female subjects during the study period up until 32 days after last study treatment (in Germany, patients who use an efficient method of hormonal contraception during the study period must continue to use this for minimum of six months after their last dose of temozolomide) and for male subjects up until 92 days after last study administration. 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 (if any/where applicable) 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).
- •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).
- •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).
- •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
- •Adequate renal function defined by an estimated creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula
排除标准
- •Known hypersensitivity to any component of the investigational product.
- •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.
- •Subjects who underwent "only biopsy" resection
- •Anticancer therapy within 4 weeks of study entry (6 weeks for mitomycin and nitrosoureas)
- •Other major surgery within the preceding 30 days
- •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.
- •Unable to undergo MRI
- •Presenting with diffuse midline gliomas or multifocal GBM (distant from the flare or contralateral) or rapid progression between early postsurgery MRI and pre-radiotherapy MRI
- •Uncontrolled or significant cardiovascular disease
- •A history of uncontrolled hyperlipidaemia and/or the need for concurrent lipid lowering therapy
- •Need for warfarin, phenytoin or sulphonylureas (glibenclamide, glimepiride, glipizide, glyburide or nateglanide)
- •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
- •Uncontrolled diabetes mellitus, with glycated haemoglobin (HbA1c) levels at the screening visit of ≥7.5%
- •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
- •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 CYP2C
- •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.
结局指标
主要结局
• PFS according to RANO criteria evaluated after at least 66 PFS events occur. Occurrence of disease progression to calculate PFS will be determined first by the investigator based on local evaluation of images and other clinical information. Progression will be confirmed by an adjudication/imaging committee. • Overall Survival evaluated after at least 90 OS events are observed.
• PFS according to RANO criteria evaluated after at least 66 PFS events occur. Occurrence of disease progression to calculate PFS will be determined first by the investigator based on local evaluation of images and other clinical information. Progression will be confirmed by an adjudication/imaging committee. • Overall Survival evaluated after at least 90 OS events are observed.
次要结局
- • Changes in neurological function, based on Neurologic Assessment in Neuro-Oncology (NANO) criteria • To evaluate additional measures of efficacy including: o Time to Progression (TTP) (as assessed using RANO criteria) • HRQoL assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, EORTC-QLQ C30, version 3.0 and brain cancer specific QLQ-BN20. • Please refer to protocol for full list
研究者
Chief of Clinical Operations
Scientific
Laminar Pharmaceuticals S.A.
研究点 (16)
Loading locations...
相似试验
尚未招募
2 期
Safety and Efficacy of Radiotherapy Combined With Immunochemotherapy in Pre-treated SCLC Patients With Liver MetastasesNCT07258147Sichuan University30
进行中（未招募）
1/2 期
A clinical trial to evaluate the safety and effectiveness of a combination of either AG-12or AG-221 tablets with azacitidine injections in patients withnewly diagnosed Acute Myeloid Leukemia (AML) and who have mutations in enzymes isocitrate dehydrogenase 1 or 2 (IDH 1 or IDH2) and are not candidates to receive intensive induction chemotherapy.2024-511722-31-00Celgene Corp.70
招募中
3 期
RACE-trial: Neoadjuvant Radiochemotherapy versus Chemotherapy for Patients with Locally Advanced, Potentially Resectable Adenocarcinoma of the Gastroesophageal Junction (GEJ)
A randomized phase III joint study of the AIO, ARO and DGAV2024-516271-32-00Universitat Heidelberg342
招募中
不适用
pAtient Reported Outcome in RadiotherApyC50C71D32C61Malignant neoplasm of breastMalignant neoplasm of brainBenign neoplasm of meningesMalignant neoplasm of prostateDRKS00013896Klinikum der Universität München, Campus Großhadern
进行中（未招募）
2 期
Efficacy and Safety of Standard of Care Plus Durvalumab in Patients With Limited Disease Small Cell Lung Cancer (DOLPHIN)Small Cell Lung Cancer Limited StageNCT04602533Michael Hopp105