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

NCT ID: NCT00256880

Last Updated: 2017-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2005-12-31

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.

Conditions

Carcinoma, Renal Cell

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

GW786034

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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

Countries

United States; Australia

References

Prince HM, Honemann D, Spencer A, Rizzieri DA, Stadtmauer EA, Roberts AW, Bahlis N, Tricot G, Bell B, Demarini DJ, Benjamin Suttle A, Baker KL, Pandite LN. Vascular endothelial growth factor inhibition is not an effective therapeutic strategy for relapsed or refractory multiple myeloma: a phase 2 study of pazopanib (GW786034). Blood. 2009 May 7;113(19):4819-20. doi: 10.1182/blood-2009-02-207209. No abstract available.

Reference Type: BACKGROUND

PMID: 19423744 (View on PubMed)

Other Identifiers

VEG20006

Identifier Type: -

Identifier Source: org_study_id