NCT01741597撤回1 期
A First Time in Human Phase I Imaging Study of iRGD in Patients With Advanced Breast and Pancreas Cancer
City of Hope Medical Center2 个研究点 分布在 1 个国家开始时间: 2014年7月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Change in volume transfer coefficient (Ktrans) during DCE-MRI with tumor-homing peptide iRGD compared to a baseline DCE-MRI without tumor-homing peptide iRGD
研究概览
简要总结
This phase I trial studies the side effects of dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) in patients with advanced breast or pancreatic cancer with metastases to the liver or lung. Diagnostic procedures, such as DCE-MRI, may help measure a patient's response to treatment
详细描述
PRIMARY OBJECTIVES:
I. To explore the ability of iRGD (tumor-homing peptide iRGD) to elicit changes in metastatic breast cancer vascular permeability as measured by dynamic contrast enhanced (DCE) MRI.
II. To evaluate the pharmacokinetics of iRGD. III. To explore the safety of iRGD.
SECONDARY OBJECTIVES:
I. To explore changes in water diffusion status in tumors due to iRGD as measured by diffusion-weighted (DWI) MRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Patient must have a histologic diagnosis of breast or pancreatic adenocarcinoma (expansion cohort) metastatic to the liver or lung
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •Women of child-bearing potential must have a negative serum pregnancy test within 7 days of the first DCE-MRI and must have agreed to use an effective contraceptive method; the effects of iRGD on the developing fetus are unknown; for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
- •Patient must have a measurable lesion at least 2 cm in size amenable to DCE-MRI study as determined by Radiology
- •Computed tomography (CT)/MRI scan must be obtained within 3 weeks prior to study entry
- •Absolute neutrophil count >= 1,500/mcl
- •Platelet count >= 100,000/mcl
- •Creatinine =< 1.3 mg/dl or a measured creatinine clearance >= 60 cc/min
- •Bilirubin =< 1.5 mg/dl
- •Alanine aminotransferase (ALT), aspartate aminotransferase (AST) no greater than 2.5 times the upper limit of normal for patients with liver metastases; patients without liver metastasis should have ALT and AST no greater than 1.5 times the upper limit of normal
- •Patients currently being treated for severe infections or who are recovering from major surgery or other intercurrent illnesses are ineligible until recovery is deemed complete by the investigator
- •All subjects must have the ability to understand and the willingness to sign a written informed consent
- •Patients with grade 2 or higher toxicity due to previous chemotherapy; all toxicities should recover to grade 0 or 1 prior to day 1
排除标准
- •Patients experiencing an infusion reaction with the day 1 DCE-MRI
- •Patients with any grade electrolyte abnormalities that are unable to be corrected by day 1
- •Patients with a history of previous reaction to IV contrast
- •Impaired cardiac function including any one of the following:
- •Complete left bundle branch block or use of a permanent cardiac pacemaker
- •Congenital long QT syndrome
- •Presence of ventricular tachyarrhythmias
- •Clinically significant resting bradycardia (< 50 beats per minute)
- •Corrected Fridericia's QT interval (QTcF) > 450 msec on screening electrocardiogram (ECG)
- •Right bundle branch block + left anterior hemiblock (bifascicular block)
- •Presence of atrial fibrillation
- •Previous history angina pectoris or acute myocardial infarction (MI) within 6 months
- •Congestive heart failure (New York Heart Association functional classification III-IV)
- •Uncontrolled hypertension (mmHg > 140 systolic or > 90 diastolic)
- •Brain or leptomeningeal metastases
- •Patients with an active, bleeding diathesis or requiring therapeutic anticoagulation
- •Patients receiving bevacizumab within 3 months of study entry
- •Patients with known positivity for human immunodeficiency virus (HIV) or hepatitis C; baseline testing for HIV and hepatitis C is not required
- •Patients should not have any uncontrolled illness including ongoing or active infection
- •Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to iRGD
- •Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
结局指标
主要结局
Change in volume transfer coefficient (Ktrans) during DCE-MRI with tumor-homing peptide iRGD compared to a baseline DCE-MRI without tumor-homing peptide iRGD
时间窗: Baseline to 15 days
Analyzed using a multi-compartment pharmacokinetic modeling algorithm already implemented at multiple clinical trial sites for breast and body imaging.
次要结局
- The potential for tumor-homing peptide iRGD to enhance uptake of key anti-cancer agents(Up to 15 days)
研究者
研究点 (2)
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