NCT00263783已完成1 期
Phase I Trial of Weekly MEDI-522 in Patients With Refractory Solid Tumors
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
- 24
- 试验地点
- 1
- 主要终点
- Safety: The incidence and severity of adverse experiences and laboratory abnormalities will be tabulated and presented overall and by dose.
研究概览
简要总结
To determine the safety profile of single and multiple doses of MEDI522 in patients with refractory solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 18 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or post menopausal female patients with histologically confirmed advanced refractory solid tumors for which no reasonable therapy exists. Patient is not required to have measurable disease.
- •Age >18 years
- •Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (see APPENDIX 1 for details).
- •Patients who had prior surgery, radiation, or chemotherapy will be eligible provided at least 4 weeks have elapsed prior to study initiation. Patients must have recovered from treatment-related toxicities, and surgical wounds must be healed.
- •Patients who have had prior immunotherapy with approved agents are eligible.
- •Patients must have hemoglobin >10.0 g/dL, ANC >1,000/mm3, WBC >3,000/mm3,000/mm3, platelets ³100,000/mm3, bilirubin £2.0 mg/dL, AST/ALT no greater than 5 times the upper limit of normal (ULN), and serum creatinine <1.5 mg/dL (or calculated creatinine clearance ³60 mL/min).
- •Patients must have prothrombin time (PT) and partial thromboplatin time (PTT) less than upper limit of normal or international normalized ratio (INR) less than 1.
- •Patients must have thyroxine (T4) and thyroid-stimulating hormone (TSH) within normal limits.
- •Patients must be informed of and understand the investigational nature of this trial and give written informed consent prior to receipt of any study medication or beginning study procedures.
排除标准
- •Patient has known brain metastases or primary brain tumors, symptomatic pleural effusion or ascites requiring paracentesis.
- •Patient has respiratory insufficiency requiring oxygen treatment, or has lymphangitic involvement of lungs.
- •Patient has evidence of hematemesis, melena, hematochezia, or hematuria (2 or greater on urine dipstick).
- •Patient has a history of a significant adverse event related to previously administered humanized monoclonal antibody.
- •Patient has known HIV or hepatitis virus infection.
- •Patient has prior myocardial infarction or angina, or uncontrolled hypertension (systolic BP >140 mm Hg).
- •Patient has either prior strokes or transient ischemic attacks.
- •Patient has active infections requiring systemic antiinfective therapy or other physical or psychological illnesses that would preclude drug administration or patient compliance.
- •Patient has donated blood or received an investigational agent in the last 4 weeks.
- •Patient has a history of active illness or behavior, including substance dependence or abuse that, in the opinion of the investigator, might pose additional risk in administering the study drug to the patient.
- •General medical or psychological conditions that would not permit the patient to complete the study or sign the informed consent
研究组 & 干预措施
1
Experimental
MEDI-522
干预措施: MEDI-522 (Drug)
结局指标
主要结局
Safety: The incidence and severity of adverse experiences and laboratory abnormalities will be tabulated and presented overall and by dose.
时间窗: Study Day 1 up to 8 weeks
次要结局
- Pharmacokinetics: Will be assessed using the variables of area under the concentration curve (AUC) which will be calculated by the trapezoidal rule, peak concentration (Cmax), time to peak concentration (Tmax), half life(35 days after the first dose)
- Measured pharmacokinetic parameters may be one of the factors used in determination of the Phase II regimen.(Appx. 5 days after the 4th weekly dose)
- Antitumor Activity: The antitumor activity of MEDI-522 in patients with refractory solid tumors will be assessed by calculating tumor response rate and time to disease progression.
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Phase 2a to Evaluate the Safety of MEDI8852 in Adults With Uncomplicated InfluenzaInfluenzaNCT02603952MedImmune LLC126
已完成
1 期
Phase I Study of MEDI522 in Patients With Irinotecan-Refractory Advanced Colorectal CancerCancerNCT00284817MedImmune LLC17
撤回
1 期
A Study of APG-1252 in Patients With Myelofibrosis Who Progressed After Initial TherapyMyelofibrosisNCT04354727Ascentage Pharma Group Inc.
已完成
1 期
Phase 1 Placebo-controlled,Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of MEDI8852 in AdultsInfluenzaNCT02350751MedImmune LLC94
撤回
1 期
A Study to Evaluate PT-523 in Patients With Refractory LeukemiaLeukemiaNCT00129558Spectrum Pharmaceuticals, Inc