NCT01624467已完成2 期
A Study to Determine Whether Necitumumab (IMC-11F8) Monotherapy Affects the Corrected QT (QTc) Interval in Patients With Advanced Solid Tumors
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 9
- 主要终点
- Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc)
研究概览
简要总结
The purpose of this study is to determine whether treatment with necitumumab monotherapy affects the QT/QTc interval among participants with advanced solid tumors refractory to standard treatment or for which no standard treatment is available.
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
- •Have documented advanced or metastatic malignant solid tumors (except for colorectal tumors with KRAS mutation) that have not responded to standard therapy or for which no standard therapy is available
- •May have measurable or non-measurable disease
- •Have resolution to Grade 0 or 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE 4.0) of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy
- •Have an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1
- •Have adequate hepatic, renal and hematologic function
- •Have potassium, magnesium, and calcium within normal limits
- •Subjects, if female, are surgically sterile, postmenopausal, or compliant with a highly effective contraceptive method during and for 6 months after the treatment period. If male, participants are surgically sterile or compliant with a highly effective contraceptive regimen during and for 6 months after the treatment period
- •Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization
排除标准
- •Are currently enrolled in, or discontinued a clinical trial involving an anticancer investigational product, or concurrently enrolled in any other type of medical research
- •Had therapeutic radiotherapy within 14 days prior to the first dose of study therapy
- •Have received necitumumab or any other monoclonal antibody (mAb) targeting the EGFR (epidermal growth factor receptor) as the most recent prior treatment
- •Have documented and/or symptomatic brain or leptomeningeal metastases
- •Have a clinically relevant abnormality on the ECG, preventing an accurate measurement of the QT interval
- •Have current clinically-relevant coronary artery disease or uncontrolled congestive heart failure
- •Have medically uncontrolled angina pectoris, or has experienced myocardial infarction within 6 months prior to the first dose of study therapy
- •Have an implantable pacemaker or automatic implantable cardioverter defibrillator
- •Have received sotalol within 10 days prior to the first dose of study therapy
- •Have a history of risk factors for ventricular tachycardia or Torsades de pointes, history of fainting, unexplained loss of consciousness, or convulsions
- •Have a history of heart failure, congestive heart failure, myocardial infarction, cardiomyopathy, hypokalemia, hypoglycemia, or hypomagnesia
- •Have any evidence of conduction abnormality (eg, increased QRS complex)
- •Have congenital long QT syndrome
- •Have a prolonged QTc interval mean on pretreatment ECG
- •Have a heart rate < 50 bpm or > 100 bpm at rest
- •Are using a medication that is known to prolong the ECG QT interval, or have received a medication known to prolong the ECG QT interval within 14 days prior to first dose of study therapy
- •Have a known allergy / history of hypersensitivity reaction to any of the treatment components, including any ingredient used in the formulation of necitumumab, or a known history of severe (Grade 3-4) hypersensitivity reaction to any monoclonal antibody
- •Have an ongoing or active infection (requiring treatment), including active tuberculosis or known infection with the human immunodeficiency virus
- •If female, are pregnant or breastfeeding
- •Have a history of significant neurological or psychiatric disorders, including dementia, seizures, or bipolar disorder
结局指标
主要结局
Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc)
时间窗: Baseline, Cycle1 Day 1, 8,15, 22, 29, and 36: Pre-infusion, End of Infusion, 1 Hour (hr), 2, 4, 24, 48, 72 hr Post Infusion
The corrected QT interval was calculated using Fridericia's correction (QTcF) from electrocardiogram (ECG) data. Each participant had triplicate QT intervals measured at each timepoint and the average was calculated for each participant at each timepoint. For each timepoint, a participant's corresponding baseline (Day -1, pretreatment) QTcF interval was subtracted from the average QTcF intervals to create the change from time-matched baseline in the QTcF interval
次要结局
- Change From Time-Matched Baseline ≥ 25% and Absolute Value of QRS >110 Msec (Electrocardiographic Parameters: QRS Interval)(Baseline, Cycle1 Day 1, 8, 15, 22, 29, 36: Pre-infusion, End of Infusion, 1 Hour (hr), 2, 4, 24, 48, 72 hr Post Infusion)
- Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) (Tumor Response Rate Per Response Evaluation Criteria in Solid Tumors Version 1.1 [RECIST 1.1])(Baseline to Measured Progressive Disease (up to 21 Months))
- PR Change From Time-Matched Baseline ≥25% and Absolute Value of PR > 200 Msec (Electrocardiographic Parameters: PR Interval)(Baseline, Cycle1 Day 1, 8, 15, 22, 29, 36: Pre-infusion, End of Infusion, 1 Hour (hr), 2, 4, 24, 48, 72 hr Post Infusion)
- Pharmacokinetics: Maximum Drug Concentration (Cmax) of Necitumumab(Cycle 1 (Days 1 and 36); Pre-infusion, 50 minutes, 1.5, 2.5, 4.5, 24, 28, 72, and 168 hours)
- Number of Participants With an Incidence of Anti-Necitumumab Antibodies(Baseline to Post Infusion 30 Day Follow-up)
- Change From Time-Matched Baseline in Heart Rate (HR) (Electrocardiographic Parameters: Heart Rate [HR])(Baseline, Cycle1 Day 36: Pre-infusion, End of Infusion, 1 Hour (hr), 2, 4, 24, 48, 72 hr Post Infusion)
- Pharmacokinetics (PK): Area Under the Concentration-Time Curve of Necitumumab From Zero to Infinity (AUC[0-∞])(Cycle1 (Days 1 and 36): Pre-infusion, 50 minutes, 1.5, 2.5, 4.5, 24, 28, 72, and 168 hours)
研究者
研究点 (9)
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