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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00256880
First received: November 21, 2005
Last updated: February 20, 2013
Last verified: February 2013

November 21, 2005
February 20, 2013
January 2005
December 2005   (final data collection date for primary outcome measure)
Evaluate the safety and tolerability of GW786034 in patients with relapsed or refractory multiple myeloma (MM).
Evaluate the safety and tolerability of GW786034 in patients with relapsed or refractory MM.
Complete list of historical versions of study NCT00256880 on ClinicalTrials.gov Archive Site
Evaluate time-to-tumor progression (TTP), time to response, and duration of response. Characterize the pharmacokinetics of GW786034 in patients with MM.
Evaluate time-to-tumor progression (TTP), time to response, and duration of response. Characterize the pharmacokinetics of GW786034 in patients with M
Not Provided
Not Provided
 
Pazopanib (GW786034) In Subjects With Relapsed Or Refractory Multiple Myeloma
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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Multiple Myeloma
  • Carcinoma, Renal Cell
Drug: GW786034
Other Name: GW786034
Not Provided
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. No abstract available.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
December 2005
December 2005   (final data collection date for primary outcome measure)

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.
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia
 
NCT00256880
VEG20006
No
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP