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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):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00387205
First received: October 10, 2006
Last updated: May 16, 2017
Last verified: May 2017
October 10, 2006
May 16, 2017
June 2006
December 31, 2017   (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. ]
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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Carcinoma, Renal Cell
Drug: Pazopanib
Pazopanib monotherapy or in combination with lapatinib or other approved anti-cancer medications
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
195
December 31, 2017
December 31, 2017   (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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France,   Singapore,   United Kingdom,   United States
Australia,   Hong Kong,   Netherlands,   Taiwan
 
NCT00387205
VEG105430
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
May 2017

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