Clinical trial NCT00387764: Extension Study to VEG105192 to Assess Pazopanib in Patients With Advanced/Metastatic Renal Cell Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carcinoma, Renal Cell
Keywords: renal cell carcinoma
pazopanib
anti-angiogenic therapy
open label
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-10-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion criteria:

* Progressed from VEG105192 study treatment
* Patient's VEG105192 was placebo
* Baseline has good organ function

Exclusion criteria:

* No brain metastasis

Primary outcomes:
measure: Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
timeFrame: From Baseline to Follow-up (up to 6.230 years)
measure: 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)
measure: Number of Participants With Adverse Events Related to Investigational Product
timeFrame: From Baseline to Follow-up (up to 6.230 years)
measure: Median Time on Investigational Product
timeFrame: From Baseline to investigational product discontinuation (up to 6.230 years)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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:
measure: 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)
measure: 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)
measure: Number of Participants With the Indicated Best Overall Response
timeFrame: From the Baseline to Week 24/investigational product discontinuation (up to 3.460 years)
measure: 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)
measure: 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)
measure: Percentage of Participants Who Survived Until Month 12
timeFrame: From the first dose of study medication to Month 12
Other outcomes:
Locations:
city: Capital Federal
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Cordoba
country: Argentina
facility: GSK Investigational Site
state: Córdova
city: Rosario
country: Argentina
facility: GSK Investigational Site
state: Santa Fe
city: Quilmes
country: Argentina
facility: GSK Investigational Site
city: Tucuman
country: Argentina
facility: GSK Investigational Site
city: Waratah
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Hobart
country: Australia
facility: GSK Investigational Site
state: Tasmania
city: Heidelberg
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Salzburg
country: Austria
facility: GSK Investigational Site
city: Vienna
country: Austria
facility: GSK Investigational Site
city: Belo Horizonte
country: Brazil
facility: GSK Investigational Site
state: Minas Gerais
city: Porto Alegre
country: Brazil
facility: GSK Investigational Site
state: Rio Grande Do Sul
city: Santiago
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
city: Viña del Mar
country: Chile
facility: GSK Investigational Site
state: Valparaíso
city: Beijing
country: China
facility: GSK Investigational Site
city: Beijing
country: China
facility: GSK Investigational Site
city: Brno
country: Czech Republic
facility: GSK Investigational Site
city: Chomutov
country: Czech Republic
facility: GSK Investigational Site
city: Praha 2
country: Czech Republic
facility: GSK Investigational Site
city: Tartu
country: Estonia
facility: GSK Investigational Site
city: Roma
country: Italy
facility: GSK Investigational Site
state: Lazio
city: Roma
country: Italy
facility: GSK Investigational Site
state: Lazio
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: songpa-gu, Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Kaunas
country: Lithuania
facility: GSK Investigational Site
city: Vilnius
country: Lithuania
facility: GSK Investigational Site
city: Christchurch
country: New Zealand
facility: GSK Investigational Site
city: Wellington
country: New Zealand
facility: GSK Investigational Site
city: Karachi
country: Pakistan
facility: GSK Investigational Site
city: Lahore
country: Pakistan
facility: GSK Investigational Site
city: Gdansk
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Kraków
country: Poland
facility: GSK Investigational Site
city: Olsztyn
country: Poland
facility: GSK Investigational Site
city: Olsztyn
country: Poland
facility: GSK Investigational Site
city: Chelyabinsk
country: Russian Federation
facility: GSK Investigational Site
city: Kazan
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Omsk
country: Russian Federation
facility: GSK Investigational Site
city: Samara
country: Russian Federation
facility: GSK Investigational Site
city: St. Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Voronezh
country: Russian Federation
facility: GSK Investigational Site
city: Yaroslavl
country: Russian Federation
facility: GSK Investigational Site
city: Bratislava
country: Slovakia
facility: GSK Investigational Site
city: Sfax
country: Tunisia
facility: GSK Investigational Site
city: Sousse
country: Tunisia
facility: GSK Investigational Site
city: Tunis
country: Tunisia
facility: GSK Investigational Site
city: Tunis
country: Tunisia
facility: GSK Investigational Site
city: Donetsk
country: Ukraine
facility: GSK Investigational Site
city: Kharkiv
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Bebington, Wirral
country: United Kingdom
facility: GSK Investigational Site
city: Belfast, Northern Ireland
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: