NCT02189109已完成1 期
A Phase 1b Dose-finding, Pharmacokinetic and Pharmacodynamic Study of NVX-108 Combined With Radiation and Temozolomide in Patients With Newly-diagnosed Glioblastoma Multiforme
NuvOx LLC4 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2014年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 4
- 主要终点
- Safety and Tolerability of NVX-108 in Combination with Radiation and Temozolomide Defined by no Drug related Adverse Events (AE) in No More than 1 Patient per Treatment Group
研究概览
简要总结
This clinical trial is testing the safety, tolerability and effectiveness of NVX-108 administered via intravenous infusion in combination with standard radiation and chemotherapy.
NVX-108 is being developed to increase the amount of oxygen delivered to tumors which is hoped to increase the effectiveness of radiation therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically-confirmed newly-diagnosed glioblastoma multiforme.
- •No prior treatment for glioblastoma apart from surgical resection.
- •No prior treatment for glioblastoma apart from surgical resection.
- •Planned for 60 Gray of focal radiation administered in 30 fractions, concurrently with temozolomide chemotherapy.
- •Manageable risks associated with potential radiation necrosis in the radiation field, based on size of the field and proximity to eloquent brain regions (as assessed by the investigator).
- •Aged 18-70 years.
- •ECOG performance status 0-
- •Life expectancy of at least 3 months.
- •If receiving glucocorticoid therapy, the dose must be stable over at least 7 days prior to study enrollment.
- •Archived tumor tissue available for central review.
- •Able to undergo gadolinium-enhanced MRI (Gd-MRI) scans.
- •Baseline MRI performed within 14 days before starting study treatment, while on a stable glucocorticoid dose for at least 5 days before and during the imaging study.
- •Adequate hematologic, renal and hepatic function, as defined by:
- •Absolute neutrophil count (ANC) ≥ 1.5 109/L Platelet count ≥ 100 109/L Hemoglobin ≥ 90 g/L International normalized ratio (INR) and activated partial thromboplastin time (APTT) < 1.5 upper limit of normal (ULN) Plasma creatinine< 1.5 ULN Total bilirubin within normal limits (< 2.5 ULN if Gilbert's syndrome) AST and ALT < 2.5 ULN
- •Patients who are women of childbearing potential or men (unless vasectomised) must agree to use a highly-effective method of birth control, such as hormonal contraceptive implants, combined oral contraceptives, an intrauterine device, a double-barrier method (eg. condom with a diaphragm) or abstinence, from study entry until 4 months after completing study therapy. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Presence of leptomeningeal disease or multifocal glioblastoma that cannot be encompassed within a feasible and safe radiation field.
- •Intracranial bleeding, except for stable grade 1 hemorrhage.
- •Has not recovered from the adverse effects of surgical resection or biopsy, except for neurological deficits.
- •Patients who have received any other investigational agent within 4 weeks before enrollment.
- •Stroke or transient ischemic attack within 6 months before enrollment.
- •Myocardial infarction within 6 months before enrollment, unstable angina, New York Heart Association class II or greater congestive heart failure, or uncontrolled hypertension (systolic BP > 160 mmHg and/or diastolic BP > 100 mmHg).
- •Congenital long QT syndrome.
- •Clinically-significant chronic obstructive pulmonary disease or asthma.
- •Active major infection requiring treatment.
- •A history of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer or other solid tumors curatively treated with no evidence of disease for ≥ 2 years.
- •Known infection with human immunodeficiency virus or hepatitis B or C virus.
- •Current anticoagulant or antiplatelet therapy, except for prophylactic doses of low molecular weight heparins or low-dose aspirin.
- •History of allergic reactions attributed to compounds of similar chemical composition to NVX-
- •Women who are pregnant or breast feeding.
- •Inability to comply with study procedures.
- •History or evidence of any other clinically-significant condition that, in the opinion of the investigator, would pose a risk to subject safety or interfere with study procedures, evaluation or completion.
研究组 & 干预措施
Dose Escalation
Experimental
NVX-108 (DDFP liquid emulsion) i.v. in conjunction with Radiation Treatment and Temozolimide. 0.05-0.35cc/kg.
干预措施: NVX-108 (Drug)
结局指标
主要结局
Safety and Tolerability of NVX-108 in Combination with Radiation and Temozolomide Defined by no Drug related Adverse Events (AE) in No More than 1 Patient per Treatment Group
时间窗: 6 months
Adverse Events are considered to be neurological and hemodynamic
次要结局
- Progression Free Survival at 6 months(6 months)
研究者
研究点 (4)
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