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 GSK Clinical Study Register is no longer maintained for this study.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
Clinicaltrials.gov ID
EudraCT ID
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
Observational study model:
Not applicable
Primary completion date:
2012-20-12
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
  • Progressed from VEG105192 study treatment
  • Patient’s VEG105192 was placebo
  • No brain metastasis

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Krakow, Poland, 31-115
Status
Study Complete
Location
GSK Investigational Site
Viña del Mar, Valparaíso, Chile, 254-0364
Status
Study Complete
Location
GSK Investigational Site
Kaunas, Lithuania, LT-50009
Status
Study Complete
Location
GSK Investigational Site
Roma, Lazio, Italy, 00152
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Lahore, Pakistan, 54600
Status
Study Complete
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90610000
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Belo Horizonte, Minas Gerais, Brazil, 30150-270
Status
Study Complete
Location
GSK Investigational Site
Roma, Lazio, Italy, 00133
Status
Study Complete
Location
GSK Investigational Site
Heidelberg, Victoria, Australia, 3084
Status
Study Complete
Location
GSK Investigational Site
Kazan, Russia, 420029
Status
Study Complete
Location
GSK Investigational Site
Tartu, Estonia, 51003
Status
Study Complete
Location
GSK Investigational Site
Seoul, South Korea, 120-752
Status
Study Complete
Location
GSK Investigational Site
Praha 2, Czech Republic, 12808
Status
Study Complete
Location
GSK Investigational Site
songpa-gu, Seoul, South Korea, 138-736
Status
Study Complete
Location
GSK Investigational Site
Yaroslavl, Russia, 150054
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Tunis, Tunisia, 1007
Status
Study Complete
Location
GSK Investigational Site
Voronezh, Russia, 394062
Status
Study Complete
Location
GSK Investigational Site
Kharkiv, Ukraine, 61037
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Beijing, China, 100853
Status
Study Complete
Location
GSK Investigational Site
Beijing, China, 100034
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bebington, Wirral, United Kingdom, CH63 4JY
Status
Study Complete
Location
GSK Investigational Site
Chelyabinsk, Russia, 454087
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Moscow, Russia, 115 478
Status
Study Complete
Location
GSK Investigational Site
Cordoba, Córdova, Argentina, 5000
Status
Study Complete
Location
GSK Investigational Site
St. Petersburg, Russia, 198255
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Salzburg, Austria, A-5020
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Kyiv, Ukraine, 03115
Status
Study Complete
Location
GSK Investigational Site
Bratislava, Slovakia, 833 10
Status
Study Complete
Location
GSK Investigational Site
Omsk, Russia, 644013
Status
Study Complete
Location
GSK Investigational Site
Olsztyn, Poland, 10-226
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Samara, Russia, 443066
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chomutov, Czech Republic, 430 12
Status
Study Complete
Location
GSK Investigational Site
Rosario, Santa Fe, Argentina, S2000KZE
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Brno, Czech Republic, 656 53
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Capital Federal, Buenos Aires, Argentina, C1405CUB
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Sousse, Tunisia, 4054
Status
Study Complete
Location
GSK Investigational Site
Quilmes, Argentina, 1878
Status
Study Complete
Location
GSK Investigational Site
Vilnius, Lithuania, LT-08660
Status
Study Complete
Location
GSK Investigational Site
Moscow, Russia, 117 837
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Donetsk, Ukraine, 83092
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Moscow, Russia, 129 128
Status
Study Complete
Location
GSK Investigational Site
Tucuman, Argentina, 4000
Status
Study Complete
Location
GSK Investigational Site
Sfax, Tunisia, 3000
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Wellington, New Zealand, 6021
Status
Study Complete
Location
GSK Investigational Site
Hobart, Tasmania, Australia, 7000
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Vienna, Austria, A-1100
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Manchester, United Kingdom, M20 4BX
Status
Study Complete
Location
GSK Investigational Site
Waratah, New South Wales, Australia, 2298
Status
Study Complete
Location
GSK Investigational Site
Christchurch, New Zealand, 8001
Status
Study Complete
Location
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7500921
Status
Study Complete
Location
GSK Investigational Site
Gdansk, Poland, 80-210
Status
Study Complete
Location
GSK Investigational Site
Riga, Latvia, LV 1002
Status
Study Complete
Location
GSK Investigational Site
Karachi, Pakistan, 74800
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Belfast, Northern Ireland, United Kingdom, BT9 7AB
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Kraków, Poland, 31-108
Status
Study Complete

Study documents

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

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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