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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: March 15, 2012
Last verified: January 2012
History of Changes
  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
Cancer
 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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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: June 2012
Estimated Primary Completion Date: June 2012 (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

  Show 19 Study Locations
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: March 15, 2012
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:
Lapatinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013