2023-506813-23-00招募中2 期
A Phase 2, double-blind, placebo-controlled, randomized, proof-of-concept study evaluating LSTA1 when added to standard of care (temozolomide) versus temozolomide and matching LSTA1 placebo in subjects with newly diagnosed Glioblastoma Multiforme (GBM)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Overall survival: Median time from randomization until death due to any cause
研究概览
简要总结
To determine the effect of LSTA1 in combination with TMZ on survival relative to matching LSTA1 placebo in combination with temozolomide in patients with newly diagnosed GBM
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment Period
- 盲法
- Double (Monitor, Carer, Investigator, Subject)
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
- •Subjects must be ≥ 18 <76 years of age at time of screening and provide a written informed consent
- •Adequate respiratory and cardiac function (PaO2 ≥ 60 mm Hg or oxygen saturation ≥ 92% on room air, and 12-lead ECG with normal tracing or non-clinically significant changes that do not require medical intervention)
- •Adequate contraception
- •Subjects must have newly diagnosed and histologically confirmed intracranial glioblastoma multiforme (GBM) according to the 2021 World Health Organization (WHO) Classification
- •Subjects must have undergone primary surgical resection for GBM followed by initial standard radiotherapy regimen (60Gy/30 fractions) in combination with temozolomide for 6 weeks
- •Subjects must have sufficient time for recovery from prior surgery (at least 4 weeks)
- •Subjects must be able to undergo serial MRIs (computerized tomography may not be a substitute for magnetic resonance imaging [MRI]).
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or
- •Life expectancy ≥ 3 months, as determined by the investigator
- •Patient may have- or continue to receive corticosteroids, by s/he must be on a stable or decreasing dose for at least 14 days prior to randomization
- •Subjects must have adequate organ and marrow function
排除标准
- •Besides initial TMZ therapy, patients with prior cytotoxic or non-cytotoxic drug therapy or experimental drug therapy including chemotherapy, hormonal therapy, or immunotherapy for the brain tumor
- •Patient has known hypersensitivity to temozolomide or compounds with similar chemical composition to temozolomide
- •Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
- •Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities.
- •Patients who received prior Gliadel wafers
- •Patients with concurrent stereotactic radiosurgery or brachytherapy
- •Patients with extracranial metastatic disease
- •Patients with leptomeningeal dissemination
- •Progression of GBM during or after the standard-of-care radiotherapy and TMZ 6-week regimen.
- •Subject has evidence of acute intracranial or intratumoral hemorrhage > Grade 1 by MRI. Subjects with resolving hemorrhage changes, punctate hemorrhage, or hemosiderin may enter the study
- •Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study treatment
- •Participation in another interventional clinical study within the last 1 year
结局指标
主要结局
Overall survival: Median time from randomization until death due to any cause
Overall survival: Median time from randomization until death due to any cause
次要结局
- 12-month survival
- 24-month survival
- Median progression-free survival (PFS) based on RANO criteria PFS at 6 months
- Median progression-free survival (PFS) based on RANO criteria PFS at 12 months
- ORR: the number of patients with documented partial or complete response (PR or CR) based on RANO criteria, relative to the screening tumor measurement, divided by the number of patients evaluable for response.
- Disease control rate
- Duration of response (DOR) for a subset of responding patients with measurable disease at baseline
- Scores on EORTC QLQ-30
研究者
Lenne-Triin Kõrgvee
Scientific
Tartu University Hospital
研究点 (4)
Loading locations...
相似试验
尚未招募
2 期
NANT 2021-02: Randomized MIBG With Vorinostat/Dinutuximab/Vorinostat + DinutuximabNeuroblastomaNCT07261241New Approaches to Neuroblastoma Therapy Consortium118
招募中
3 期
Extension Study for Participants in Studies That Include Pembrolizumab2022-501254-10-00Merck Sharp & Dohme LLC1,133
尚未招募
3 期
Open-Label Extension Study of MHB018A in Subjects With Thyroid Eye DiseaseNCT07262476Minghui Pharmaceutical (Hangzhou) Ltd258
招募中
3 期
Apa/Enza-short Study: Shorter Treatment With Androgen Receptor Pathway Inhibitor in Patients With Low-volume Metastatic Castration-sensitive Prostate CancerProstate CancerNCT07260435Nick Beije400
招募中
1 期
Evaluation of the Safety, Tolerability and Pharmacokinetics of HY6725 in Healthy Adult ParticipantsNCT07262281Newsoara Biopharma Co., Ltd.74