Last updated: 11/04/2018 13:27:55
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.

Extension Study to VEG105192 to Assess Pazopanib in Patients with Advanced/Metastatic Renal Cell Cancer

GSK study ID
VEG107769
See study documents
Clinicaltrials.gov ID
NCT00387764
See results summary
EudraCT ID
2006-002381-18
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An open-label extension study to assess the safety and efficacy of pazopanib in subjects with renal cell carcinoma previously enrolled on protocol VEG105192
Trial description: This is an open-label, international, multi-center study designed to provide access to pazopanib for subjects who have been enrolled in the Phase III renal cell carcinoma study (VEG105192) and have progressed on placebo. Subjects will receive 800 mg pazopanib once daily. The study treatment will continue until subjects experience disease progression, unacceptable toxicity, withdrawal of consent, or death. The primary objective of the study is to evaluate the safety and tolerability of pazopanib for the treatment of renal cell carcinoma. The secondary objectives of the study are to assess response rate (defined as complete response or partial response), progression-free survival, and overall survival. Response rates will be collected per investigator assessment (no central review). Subjects will have a CT/MRI scan every 6 weeks until week 24 and every 12 weeks thereafter.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Number of participants with any adverse event (AE) or serious adverse event (SAE)

Timeframe: From Baseline to Follow-up (up to 6.230 years)

Number of participants with any adverse event (serious and non-serious) of the indicated severity, per National Cancer Institute (NCI) Common Terminology Criteria in Adverse Events (CTCAE)

Timeframe: From Baseline to Follow-up (up to 6.230 years)

Number of participants with adverse events related to investigational product

Timeframe: From Baseline to Follow-up (up to 6.230 years)

Median time on investigational product

Timeframe: From Baseline to investigational product discontinuation (up to 6.230 years)

Number of participants with the indicated worst-case toxicity grade increase from Baseline for the indicated clinical chemistry parameters at any time post-Baseline

Timeframe: From Baseline to investigational product discontinuation (up to 6.230 years)

Number of participants with the indicated worst-case grade increase from Baseline for the indicated hematology parameters at any time post-Baseline

Timeframe: From Baseline to investigational product discontinuation (up to 6.230 years)

Number of participants with the indicated shift from Baseline in blood pressure at any time post-Baseline

Timeframe: From Baseline to investigational product discontinuation (up to 6.230 years)

Number of participants with the indicated shift in heart rate from Baseline at any time post-Baseline

Timeframe: From Baseline to investigational product discontinuation (up to 6.230 years)

Number of participants with a change from Baseline to the indicated worst-case post-Baseline Bazett's heart rate-corrected QT interval (QTc) value

Timeframe: From Baseline to investigational product discontinuation (up to 6.230 years)

Secondary outcomes:

Number of participants with a complete response (CR) or partial response (PR)

Timeframe: From Baseline to Week 24/investigational product discontinuation (up to 3.460 years)

Number of participants with a response of confirmed CR+PR+6-month stable disease (SD)

Timeframe: From the Baseline to Week 24/investigational product discontinuation (up to 1.65 years)

Number of participants with the indicated best overall response

Timeframe: From the Baseline to Week 24/investigational product discontinuation (up to 3.460 years)

Progression-free Survival (PFS)

Timeframe: From the first dose of study medication to the earliest date of disease progression (PD) or death due to any cause (up to 3.460 years)

Overall survival (OS)

Timeframe: From the first dose of study medication to the earliest date of disease progression (PD) or death due to any cause (up to 3.460 years)

Percentage of participants who survived until Month 12

Timeframe: From the first dose of study medication to Month 12

Interventions:
  • Drug: pazopanib
    • Enrollment:
    80
    Primary completion date:
    2012-20-12
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Carcinoma, Renal Cell
    Product
    pazopanib
    Collaborators
    Not applicable
    Study date(s)
    September 2006 to December 2012
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Progressed from VEG105192 study treatment
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Progressed from VEG105192 study treatment
    • Patient’s VEG105192 was placebo
    • Baseline has good organ function Exclusion criteria:
    • No brain metastasis

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Krakow, Poland, 31-115
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Viña del Mar, Valparaíso, Chile, 254-0364
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Kaunas, Lithuania, LT-50009
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Roma, Lazio, Italy, 00152
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Lahore, Pakistan, 54600
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Porto Alegre, Rio Grande Do Sul, Brazil, 90610000
    Status
    Terminated/Withdrawn
    Contact us
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    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    No longer a GSK study
    Actual primary completion date
    2012-20-12
    Actual study completion date
    2012-20-12

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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    Access to clinical trial data by researchers
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