NCT01578564已完成1 期
Phase I, Open-label, Dose Escalation Study to Assess Safety and Tolerability of SOR-C13 in Subjects With Advanced Solid Tumors Commonly Known to Express the TRPV6 Ion Channel
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 3
- 主要终点
- Toxicity graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
研究概览
简要总结
The purpose of this study is to determine the safety and tolerability of the drug SOR-C13 when given as an intravenous infusion in patients with ovarian cancer or other cancers known to over express the TRPV6 calcium channel.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Chemotherapy, immunotherapy, radiotherapy, biologic or any investigational therapy will not be allowed within either 30 days, or 5 half lives (whichever is longer) prior to study drug administration.
- •History or clinical evidence of central nervous system (CNS) tumor involvement (metastases) or other known clinically relevant CNS pathology (e.g., epilepsy, seizure, paresis, aphasia, cerebellar disease, severe brain injury, psychosis).
- •Concurrent malignancy other than the solid tumor under investigation, requiring active treatment.
- •History of clinically significant allergic reaction attributed to any injected compound.
- •History of any of the following cardiovascular events or conditions within the past 6 months prior to enrolment: myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, New York Heart Association Class ≥ II chronic heart failure, hypokalemia, significant arrhythmia*; QTc interval >430 msec or use of drugs that prolong the QT interval at screening; family history of long QT syndrome.(* Significant arrhythmias are defined as symptoms of syncope or severe palpitations (palpitations requiring referral to cardiac monitoring), or ECG findings of supraventricular tachycardia (including ventricular fibrillation) or ventricular ectopy (ventricular premature depolarization).
- •Clinically significant and uncontrolled major medical condition(s) that places the subject at an unacceptably high risk for toxicities. These include, but are not limited to: active infections, symptomatic pulmonary disease, inadequate pulmonary function, seizure disorder, psychiatric illness.
- •Current use of more than one antihypertensive medication.
- •For patients receiving antihypertensive medication:systolic blood pressure < 120 mmHg and/or diastolic blood pressure < 70 mmHg at screening.
- •A known diagnosis of human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS), acute or chronic hepatitis B or hepatitis C infection, as determined by medical history.
- •Major surgical procedure within 4 weeks prior to enrolment.
- •Lactating or pregnant female.
- •Females of childbearing potential and males not using adequate birth control.
- •Current treatment or treatment within 4 weeks of screening with bisphosphonates.
- •Screening serum calcium levels < 2.20 mmol/L [8.8 mg/dL] (after correction for serum albumin
- •History of acute pancreatitis within 12 months prior to screening
- •Known hypoparathyroidism, pseudohypoparathyroidism, or vitamin D deficiency, or clinical evidence of other conditions known to associated with hypocalcemia, including:, hypoalbuminemia, hyperphosphatemia, hypomagnesemia
- •Current treatment or treatment within 4 weeks of screening with drugs known to reduce serum calcium levels, including: bisphosphonates, antiepileptic drugs, cinacalcet, macrolide antibiotics (such as erythromycin, azithromycin), large doses of corticosteroids (>20 mg/day of prednisone or equivalent), or any IV use of corticosteroids. In addition, long-term use (defined as ongoing use for ≥4 weeks) of corticosteroids within 8 weeks of screening is prohibited
- •Any history of a venous thromboembolic event (VTE), including deep vein thrombosis (DVT) or pulmonary embolism (PE)
- •Current treatment or treatment within 7 days of screening with a vitamin K antagonist, such as warfarin. Patients who require anticoagulation due to their central line may receive an alternative agent, such as low molecular weight heparin (LMWH).
研究组 & 干预措施
SOR-C13
Experimental
干预措施: SOR-C13 (Drug)
结局指标
主要结局
Toxicity graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
时间窗: Over 21 days from initial administration
次要结局
- Plasma levels of SOR-C13(Pre-treatment and up to 4 hours post-treatment on Study Days 1, 3, 8 and 10)
研究者
研究点 (3)
Loading locations...
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