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

Carcinoma, Renal Cell Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00256880
• Other study ID #: VEG20006
• Status: Completed
• Phase: Phase 2
• First received: November 21, 2005
• Last updated: January 16, 2017
• Start date: January 2005
• Est. completion date: December 2005

Study information

• Verified date: January 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Multiple Myeloma

Intervention

Drug:
• GW786034

Locations

Country	Name	City	State
Australia	GSK Investigational Site	East Melbourne	Victoria
Australia	GSK Investigational Site	Melbourne	Victoria
Australia	GSK Investigational Site	Melbourne	Victoria
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Durham	North Carolina
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Australia, 

References & Publications (1)

Prince HM, Hönemann 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the safety and tolerability of GW786034 in patients with relapsed or refractory multiple myeloma (MM).
Secondary	Evaluate time-to-tumor progression (TTP), time to response, and duration of response. Characterize the pharmacokinetics of GW786034 in patients with MM.