Study To Assess Long Term Safety Of Pazopanib

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00387205
First received: October 10, 2006
Last updated: September 5, 2013
Last verified: August 2013
  Purpose

This study is a rollover study to evaluate the long term safety of pazopanib and to continue to provide pazopanib to patients who participated in a GSK sponsored pazopanib study until pazopanib is available commercially.


Condition Intervention Phase
Carcinoma, Renal Cell
Drug: Pazopanib
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Phase Ib Study to Assess the Long Term Safety Profile of Pazopanib in Cancer Patients

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • To evaluate the long-term safety of repeat daily doses of pazopanib in cancer subjects with solid tumors [ Time Frame: Subjects will stay on the study as long as they are benefiting from treatment, have not met one of the stopping criteria, or experienced a toxicity up to 72 months. ] [ Designated as safety issue: No ]
    To evaluate the safety assessments; adverse events, vital signs, physical examinations, electrocardiograms, multi-gated acquisition scans or echocardiograms (only for patients on pazopanib and lapatinib combination therapy), and clinical laboratory assessments.


Estimated Enrollment: 200
Study Start Date: May 2006
Estimated Study Completion Date: December 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Pazopanib monotherapy or in combination with lapatinib or other approved anti-cancer medications
Drug: Pazopanib
Pazopanib monotherapy or in combination with lapatinib or other approved anti-cancer medications
Other Name: Pazopanib

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participated or completed a GSK sponsored pazopanib study and remains eligible for continued treatment with pazopanib and lapatinib (if on combination therapy).
  • Able to understand and provide written informed consent
  • Women and men agree to use protocol specific birth control measures

Exclusion Criteria:

  • The subject has a treatment related serious adverse event that remains unresolved or unstable or had pazopanib permanently stopped in a previous study because of intolerate or because it was unsuccessful in treating your cancer
  • If you are pregnant or breast feeding
  • Your doctor does not think you would be a good candidate for the study
  • Poorly controlled high blood pressure
  • Subject is unwilling or unable to follow the procedures outlined in the protocol.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00387205

Locations
United States, California
GSK Investigational Site
Duarte, California, United States, 91010
GSK Investigational Site
Santa Monica, California, United States, 90404
United States, Colorado
GSK Investigational Site
Aurora, Colorado, United States, 80045
United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
United States, Michigan
GSK Investigational Site
Detroit, Michigan, United States, 48201
United States, Minnesota
GSK Investigational Site
Minneapolis, Minnesota, United States, 55404
United States, New Hampshire
GSK Investigational Site
Lebanon, New Hampshire, United States, 03756
United States, New York
GSK Investigational Site
Buffalo, New York, United States, 14263
United States, Ohio
GSK Investigational Site
Cleveland, Ohio, United States, 44106
United States, South Carolina
GSK Investigational Site
Greenville, South Carolina, United States, 29605
United States, Washington
GSK Investigational Site
Tacoma, Washington, United States, 98405
France
GSK Investigational Site
Lyon Cedex 08, France, 69373
Singapore
GSK Investigational Site
Singapore, Singapore, 119074
United Kingdom
GSK Investigational Site
Sutton, Surrey, United Kingdom, SM2 5PT
GSK Investigational Site
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00387205     History of Changes
Other Study ID Numbers: VEG105430
Study First Received: October 10, 2006
Last Updated: September 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Pazopanib
monotherapy and combination therapies
cancer
malignant tumor
safety
chronic administration
lapatinib (TYKERB, TYVERB)
solid
GW786034

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Lapatinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014