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Study To Assess Long Term Safety Of Pazopanib

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00387205
First Posted: October 12, 2006
Last Update Posted: May 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  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: Intervention Model: Single Group Assignment
Masking: None (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 Novartis ( Novartis Pharmaceuticals ):

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. ]
    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.


Enrollment: 195
Study Start Date: June 2006
Estimated Study Completion Date: December 31, 2017
Estimated Primary Completion Date: December 31, 2017 (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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00387205


  Hide Study Locations
Locations
United States, California
Novartis Investigative Site
Duarte, California, United States, 91010
Novartis Investigative Site
Santa Monica, California, United States, 90404
United States, Colorado
Novartis Investigative Site
Aurora, Colorado, United States, 80045
United States, Indiana
Novartis Investigative Site
Indianapolis, Indiana, United States, 46202
United States, Michigan
Novartis Investigative Site
Detroit, Michigan, United States, 48201
United States, Minnesota
Novartis Investigative Site
Minneapolis, Minnesota, United States, 55404
United States, New Hampshire
Novartis Investigative Site
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Novartis Investigative Site
New Brunswick, New Jersey, United States, 08901
United States, New York
Novartis Investigative Site
Buffalo, New York, United States, 14263
United States, North Carolina
Novartis Investigative Site
Durham, North Carolina, United States, 27710
United States, Ohio
Novartis Investigative Site
Cleveland, Ohio, United States, 44106
United States, South Carolina
Novartis Investigative Site
Greenville, South Carolina, United States, 29605
United States, Tennessee
Novartis Investigative Site
Nashville, Tennessee, United States, 37203
United States, Texas
Novartis Investigative Site
Houston, Texas, United States, 77030-4009
United States, Washington
Novartis Investigative Site
Tacoma, Washington, United States, 98405
France
Novartis Investigative Site
Lyon Cedex 08, France, 69373
Singapore
Novartis Investigative Site
Singapore, Singapore, 119074
United Kingdom
Novartis Investigative Site
Sutton, Surrey, United Kingdom, SM2 5PT
Novartis Investigative Site
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00387205     History of Changes
Other Study ID Numbers: VEG105430
First Submitted: October 10, 2006
First Posted: October 12, 2006
Last Update Posted: May 18, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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

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