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

January 16, 2017 updated by: GlaxoSmithKline

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • GSK Investigational Site
      • Melbourne, Victoria, Australia, 3004
        • GSK Investigational Site
      • Melbourne, Victoria, Australia, 3050
        • GSK Investigational Site
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • GSK Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • GSK Investigational Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • GSK Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • GSK Investigational Site
    • Washington
      • Seattle, Washington, United States, 98109
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

November 21, 2005

First Submitted That Met QC Criteria

November 21, 2005

First Posted (Estimate)

November 22, 2005

Study Record Updates

Last Update Posted (Estimate)

January 18, 2017

Last Update Submitted That Met QC Criteria

January 16, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VEG20006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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