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An Open-Label, Phase Ib Study to Assess the Long Term Safety Profile of Pazopanib in Cancer Patients


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Cancer

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Trial Information

An Open-Label, Phase Ib Study to Assess the Long Term Safety Profile of Pazopanib in Cancer Patients


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the long-term safety of repeat daily doses of pazopanib in cancer subjects with solid tumors

Outcome Description:

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.

Outcome 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.

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

VEG105430

NCT ID:

NCT00387205

Start Date:

May 2006

Completion Date:

June 2012

Related Keywords:

  • Cancer
  • Pazopanib
  • monotherapy and combination therapies
  • cancer
  • malignant tumor
  • safety
  • chronic administration
  • lapatinib (TYKERB, TYVERB)
  • solid
  • GW786034

Name

Location

GSK Investigational SiteBakersfield, California  93309
GSK Investigational SiteIndianapolis, Indiana  46260
GSK Investigational SiteDuluth, Minnesota  55805
GSK Investigational SiteRaleigh, North Carolina  27609
GSK Investigational SiteAkron, Ohio  44304
GSK Investigational SiteFort Worth, Texas  76104
GSK Investigational SiteRoyal Oak, Michigan  48073
GSK Investigational SiteHooksett, New Hampshire  03106
GSK Investigational SiteColumbia, South Carolina  29210
GSK Investigational SiteGermantown, Tennessee  38138
GSK Investigational SiteNew York, New York  10021
GSK Investigational SiteAurora, Colorado  80012
GSK Investigational SiteEdison, New Jersey  08837
GSK Investigational SiteSeattle, Washington  98133