Pazopanib (GW786034) In Subjects With Relapsed Or Refractory Multiple Myeloma

GlaxoSmithKline100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Carcinoma, Renal Cell

Interventions

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion criteria: * 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/mm3. * renal function (calculated creatinine clearance \>50 mL.min, albumin less than or equal to 500 mg). Exclusion criteria: * 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.

Locations (8)

GSK Investigational Site

Little Rock, Arkansas, United States

GSK Investigational Site

Boston, Massachusetts, United States

GSK Investigational Site

Durham, North Carolina, United States

GSK Investigational Site

Philadelphia, Pennsylvania, United States

GSK Investigational Site

Seattle, Washington, United States

GSK Investigational Site

East Melbourne, Victoria, Australia

GSK Investigational Site

Melbourne, Victoria, Australia

GSK Investigational Site

Melbourne, Victoria, Australia

Outcomes

Primary Outcomes

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

Secondary Outcomes

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