Pazopanib (GW786034) In Subjects With Relapsed Or Refractory Multiple Myeloma - Full Text View

Purpose

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.

Condition	Intervention	Phase
Multiple Myeloma	Drug: GW786034	Phase II

Genetics Home Reference related topics:

aceruloplasminemia hemophilia

MedlinePlus related topics:

Cancer Multiple Myeloma

ChemIDplus related topics:

Pazopanib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	100
Study Start Date:	January 2005

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256880

Locations


United States, Arkansas
	GSK Clinical Trials Call Center
	Little Rock, Arkansas, United States, 72205

United States, Massachusetts
	GSK Clinical Trials Call Center
	Boston, Massachusetts, United States, 022115

United States, New York
	GSK Clinical Trials Call Center
	New York, New York, United States, 10011-8202

United States, North Carolina
	GSK Clinical Trials Call Center
	Durham, North Carolina, United States, 27710

United States, Ohio
	GSK Clinical Trials Call Center
	Cleveland, Ohio, United States, 44195

United States, Oregon
	GSK Clinical Trials Call Center
	Portland, Oregon, United States, 97239-3098

United States, Pennsylvania
	GSK Clinical Trials Call Center
	Philadelphia, Pennsylvania, United States, 19104

United States, Washington
	GSK Clinical Trials Call Center
	Seattle, Washington, United States, 98109

Australia, Victoria
	GSK Clinical Trials Call Center
	East Melbourne, Victoria, Australia, 3002
	GSK Clinical Trials Call Center
	Melbourne, Victoria, Australia, 3004
	GSK Clinical Trials Call Center
	Melbourne, Victoria, Australia, 3052

Canada, Alberta
	GSK Clinical Trials Call Center
	Calgary, Alberta, Canada, T2N 4N2

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials Call Center, MD	GlaxoSmithKline

More Information

Study ID Numbers:	VEG20006
First Received:	November 21, 2005
Last Updated:	September 12, 2007
ClinicalTrials.gov Identifier:	NCT00256880
Health Authority:	United States: Food and Drug Administration; Australia: National Health and Medical Research Council

Keywords provided by GlaxoSmithKline:

Myeloma

Solid Tumors

Pazopanib(GW786034)

Study placed in the following topic categories:

Immunoproliferative Disorders

Hemorrhagic Disorders

Multiple myeloma

Hematologic Diseases

Blood Protein Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Lymphoproliferative Disorders

Hemostatic Disorders

Neoplasms, Plasma Cell

Multiple Myeloma

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Immune System Diseases

Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 19, 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00256880