A Phase II, Open-Label Study of Pazopanib (GW786034) in Patients With Relapsed or Refractory Multiple Myeloma

GlaxoSmithKline9 个研究点分布在 2 个国家目标入组 100 人开始时间: 2005年1月1日最近更新: 2017年1月18日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: GlaxoSmithKline
入组人数: 100
试验地点: 9
主要终点: Evaluate the safety and tolerability of GW786034 in patients with relapsed or refractory multiple myeloma (MM).

研究概览研究设计入排标准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 determine how effective and safe a new investigational drug is in treating patients with relapsed or refractory multiple myeloma. The treatment involves daily dosing. A patient may continue to receive the treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times to measure the amount of drug in your body at specific times after the drug is given. Blood samples will also be taken for lab tests such as complete blood counts and clinical chemistries. Physical exams will be performed before each treatment. During the treatment phase, the patients will undergo regular assessments for safety and clinical response.

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

入选标准

•Must have diagnosis of relapsed or refractory multiple.
•bone marrow function [ANC (absolute neutrophil count) greater than 1000/mm3]; platelet count greater than or equal to 75,000/mm
•renal function (calculated creatinine clearance >50 mL.min, albumin less than or equal to 500 mg).

排除标准

•Failed more than 3 prior lines of therapy including stem cell transplant.
•Females who are pregnant or nursing.
•Unstable blood pressure.
•Significant heart conditions or history of thrombosis.
•Any unstable, pre-existing major medical condition or history of other cancers.
•Have received an investigational drug, chemotherapy, radiation treatment or surgery within 28 days prior to entering the study.

结局指标

主要结局

Evaluate the safety and tolerability of GW786034 in patients with relapsed or refractory multiple myeloma (MM).

次要结局

Evaluate time-to-tumor progression (TTP), time to response, and duration of response. Characterize the pharmacokinetics of GW786034 in patients with MM.

研究者

发起方

GlaxoSmithKline

申办方类型

Industry

责任方

Sponsor

研究点 (9)

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