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

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00256880

Collaborator

(none)

100

Enrollment

Locations

Duration (Months)

12.5

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Carcinoma, Renal Cell	Drug: GW786034	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2005

Actual Study Completion Date :

Dec 1, 2005

Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Little Rock	Arkansas	United States	72205
2	GSK Investigational Site	Boston	Massachusetts	United States	02115
3	GSK Investigational Site	Durham	North Carolina	United States	27710
4	GSK Investigational Site	Philadelphia	Pennsylvania	United States	19104
5	GSK Investigational Site	Seattle	Washington	United States	98109
6	GSK Investigational Site	East Melbourne	Victoria	Australia	3002
7	GSK Investigational Site	Melbourne	Victoria	Australia	3004
8	GSK Investigational Site	Melbourne	Victoria	Australia	3050