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OpenTrials
Completed

NCT Number: NCT00256880

Pazopanib (GW786034) In Subjects 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.

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Key information

Conditions

Carcinoma, Renal Cell Adenocarcinoma Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Plasma Cell Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, East Melbourne, Victoria, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GW786034

Drug

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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2005
First posted
Nov 22, 2005
Registry last updated
Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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