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

October 10, 2006
September 5, 2013
May 2006
February 2013   (final data collection date for primary outcome measure)
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.
Incidence and frequency of adverse events and laboratory abnormalities
Complete list of historical versions of study NCT00387205 on ClinicalTrials.gov Archive Site
Not Provided
Response of the disease (every 12 weeks) with continued pazopanib treatment.
Not Provided
Not Provided
 
Study To Assess Long Term Safety Of Pazopanib
An Open-Label, Phase Ib Study to Assess the Long Term Safety Profile of Pazopanib in Cancer Patients

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Renal Cell
Drug: Pazopanib
Pazopanib monotherapy or in combination with lapatinib or other approved anti-cancer medications
Other Name: Pazopanib
Experimental: Arm 1
Pazopanib monotherapy or in combination with lapatinib or other approved anti-cancer medications
Intervention: Drug: Pazopanib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
December 2013
February 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Singapore,   United Kingdom
 
NCT00387205
VEG105430
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP