临床试验/NCT01026233

NCT01026233已完成1 期

An Intensive QT/QTc Study to Investigate the Effects of SGN-35 (Brentuximab Vedotin) on Cardiac Ventricular Repolarization in Patients With CD30-Positive Malignancies

Seagen Inc.9 个研究点分布在 2 个国家目标入组 52 人开始时间: 2010年1月最近更新: 2014年12月12日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Seagen Inc.
入组人数: 52
试验地点: 9
主要终点: QTc interval

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate cardiac safety of brentuximab vedotin (SGN-35) in patients with CD30-positive cancers. The study will assess electrical activity of the heart before and after brentuximab vedotin administration. Patients who have stable or improving disease may receive up to 1 year of brentuximab vedotin treatment.

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 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Relapsed or refractory CD30-positive malignancy
•Adequate organ function
•ECOG performance status <2

排除标准

•Cardiac abnormalities (abnormal rhythm, history of significant cardiac event)
•Current diagnosis of primary cutaneous ALCL
•Acute or chronic graft-versus-host disease
•Prior hematopoietic stem cell transplant within specified timeframe

研究组 & 干预措施

1

Experimental

brentuximab vedotin

干预措施: brentuximab vedotin (Drug)

结局指标

主要结局

QTc interval

时间窗: 2-4 days postdose

次要结局

Blood MMAE levels(Through 4 days postdose)
ECG parameters(2-4 days postdose)
Incidence of proarrhythmic adverse events(Through 1 month following last dose)
Incidence of adverse events and laboratory abnormalities(Through 1 month following last dose)

研究者

发起方

Seagen Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (9)

Loading locations...

相似试验

已完成

2 期

Brentuximab Vedotin (SGN-35) in Patients With Mycosis Fungoides With Variable CD30 Expression LevelNon-Hodgkin Lymphoma (NHL)Cutaneous LymphomaCutaneous T-cell Lymphoma (CTCL)Mycosis FungoidesSezary Syndrome

NCT01396070Youn Kim36

已完成

1 期

A Phase 1 Study of Brentuximab Vedotin Given Sequentially and Combined With Multi-Agent Chemotherapy for CD30-Positive Mature T-Cell and NK-Cell NeoplasmsLymphoma, Large-Cell, AnaplasticLymphoma, NK-cellLymphoma, T-cell

NCT01309789Seagen Inc.39

进行中（未招募）

2 期

SGN-35 in CD30-positive Lymphoproliferative Disorders (ALCL), Mycosis Fungoides (MF), and Extensive Lymphomatoid Papulosis (LyP)CD-30 Positive Anaplastic Large T-cell Cutaneous LymphomaLymphoma, Primary Cutaneous Anaplastic Large CellLymphomatoid PapulosisMycosis FungoidesSkin LymphomaCutaneous LymphomasHematologic DisorderLymphoma

NCT01352520M.D. Anderson Cancer Center79

已完成

1 期

Brentuximab Vedotin and Gemcitabine Hydrochloride in Treating Younger Patients With Relapsed or Refractory Hodgkin LymphomaRecurrent Adult Hodgkin LymphomaRecurrent Childhood Hodgkin LymphomaRefractory Childhood Hodgkin Lymphoma

NCT01780662National Cancer Institute (NCI)46

进行中（未招募）

1 期

Study of Brentuximab Vedotin in Children and Adolescents With Relapsed or Refractory Systemic Anaplastic Large-Cell Lymphoma or Hodgkin LymphomaRelapsed or Refractory Systemic Anaplastic Large-Cell Lymphoma or Hodgkin LymphomaMedDRA version: 14.1Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2011-001240-29-ITMILLENNIUM PHARMACEUTICALS, INC.42