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
  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
Carcinoma, Renal Cell
Drug: GW786034
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, Open-Label Study of Pazopanib (GW786034) in Patients With Relapsed or Refractory Multiple Myeloma

Resource links provided by NLM:


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
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: GW786034
    Other Name: GW786034
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Arkansas
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
United States, Massachusetts
GSK Investigational Site
Boston, Massachusetts, United States, 02115
United States, North Carolina
GSK Investigational Site
Durham, North Carolina, United States, 27710
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19104
United States, Washington
GSK Investigational Site
Seattle, Washington, United States, 98109
Australia, Victoria
GSK Investigational Site
East Melbourne, Victoria, Australia, 3002
GSK Investigational Site
Melbourne, Victoria, Australia, 3004
GSK Investigational Site
Melbourne, Victoria, Australia, 3050
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00256880     History of Changes
Other Study ID Numbers: VEG20006
Study First Received: November 21, 2005
Last Updated: February 20, 2013
Health Authority: Australia: National Health and Medical Research Council
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Pazopanib(GW786034)
Solid Tumors
Myeloma

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Multiple Myeloma
Neoplasms, Plasma Cell
Adenocarcinoma
Blood Protein Disorders
Carcinoma
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Kidney Diseases
Kidney Neoplasms
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Paraproteinemias
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014