NCT00256880

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2005

Shorter than P25 for phase_2

Geographic Reach
2 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 22, 2005

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

First QC Date

November 21, 2005

Last Update Submit

January 16, 2017

Conditions

Carcinoma, Renal Cell

Keywords

Pazopanib(GW786034)Solid TumorsMyeloma

Outcome Measures

Primary Outcomes (1)

  • Evaluate the safety and tolerability of GW786034 in patients with relapsed or refractory multiple myeloma (MM).

Secondary Outcomes (1)

  • Evaluate time-to-tumor progression (TTP), time to response, and duration of response. Characterize the pharmacokinetics of GW786034 in patients with MM.

Interventions

GW786034DRUG

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

GSK Investigational Site

Little Rock, Arkansas, 72205, United States

Location

GSK Investigational Site

Boston, Massachusetts, 02115, United States

Location

GSK Investigational Site

Durham, North Carolina, 27710, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19104, United States

Location

GSK Investigational Site

Seattle, Washington, 98109, United States

Location

GSK Investigational Site

East Melbourne, Victoria, 3002, Australia

Location

GSK Investigational Site

Melbourne, Victoria, 3004, Australia

Location

GSK Investigational Site

Melbourne, Victoria, 3050, Australia

Location

Related Publications (1)

  • 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.

    PMID: 19423744BACKGROUND

MeSH Terms

Conditions

Carcinoma, Renal CellNeoplasms, Plasma Cell

Interventions

pazopanib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2005

First Posted

November 22, 2005

Study Start

January 1, 2005

Study Completion

December 1, 2005

Last Updated

January 18, 2017

Record last verified: 2017-01

Locations

US(5)AU(3)