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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00387764




Registration number
NCT00387764
Ethics application status
Date submitted
12/10/2006
Date registered
13/10/2006
Date last updated
14/01/2014

Titles & IDs
Public title
Extension Study to VEG105192 to Assess Pazopanib in Patients With Advanced/Metastatic Renal Cell Cancer
Scientific 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
Secondary ID [1] 0 0
VEG107769
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Renal Cell 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - pazopanib

Experimental: pazopanib arm - This was a single arm study, therefore no control arm.


Treatment: Drugs: pazopanib
800 mg daily dosing continously until progression
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
Timepoint [1] 0 0
From Baseline to Follow-up (up to 6.230 years)
Primary outcome [2] 0 0
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)
Timepoint [2] 0 0
From Baseline to Follow-up (up to 6.230 years)
Primary outcome [3] 0 0
Number of Participants With Adverse Events Related to Investigational Product
Timepoint [3] 0 0
From Baseline to Follow-up (up to 6.230 years)
Primary outcome [4] 0 0
Median Time on Investigational Product
Timepoint [4] 0 0
From Baseline to investigational product discontinuation (up to 6.230 years)
Primary outcome [5] 0 0
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
Timepoint [5] 0 0
From Baseline to investigational product discontinuation (up to 6.230 years)
Primary outcome [6] 0 0
Number of Participants With the Indicated Worst-case Grade Increase From Baseline for the Indicated Hematology Parameters at Any Time Post-Baseline
Timepoint [6] 0 0
From Baseline to investigational product discontinuation (up to 6.230 years)
Primary outcome [7] 0 0
Number of Participants With the Indicated Shift From Baseline in Blood Pressure at Any Time Post-Baseline
Timepoint [7] 0 0
From Baseline to investigational product discontinuation (up to 6.230 years)
Primary outcome [8] 0 0
Number of Participants With the Indicated Shift in Heart Rate From Baseline at Any Time Post-Baseline
Timepoint [8] 0 0
From Baseline to investigational product discontinuation (up to 6.230 years)
Primary outcome [9] 0 0
Number of Participants With a Change From Baseline to the Indicated Worst-case Post-Baseline Bazett's Heart Rate-corrected QT Interval (QTc) Value
Timepoint [9] 0 0
From Baseline to investigational product discontinuation (up to 6.230 years)
Secondary outcome [1] 0 0
Number of Participants With a Complete Response (CR) or Partial Response (PR)
Timepoint [1] 0 0
From Baseline to Week 24/investigational product discontinuation (up to 3.460 years)
Secondary outcome [2] 0 0
Number of Participants With a Response of Confirmed CR+PR+6-month Stable Disease (SD)
Timepoint [2] 0 0
From the Baseline to Week 24/investigational product discontinuation (up to 1.65 years)
Secondary outcome [3] 0 0
Number of Participants With the Indicated Best Overall Response
Timepoint [3] 0 0
From the Baseline to Week 24/investigational product discontinuation (up to 3.460 years)
Secondary outcome [4] 0 0
Progression-free Survival (PFS)
Timepoint [4] 0 0
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)
Secondary outcome [5] 0 0
Overall Survival (OS)
Timepoint [5] 0 0
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)
Secondary outcome [6] 0 0
Percentage of Participants Who Survived Until Month 12
Timepoint [6] 0 0
From the first dose of study medication to Month 12

Eligibility
Key inclusion criteria
Inclusion criteria:

- Progressed from VEG105192 study treatment

- Patient's VEG105192 was placebo

- Baseline has good organ function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- No brain metastasis

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2012
Sample size
Target
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
NSW,TAS,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Waratah
Recruitment hospital [2] 0 0
GSK Investigational Site - Hobart
Recruitment hospital [3] 0 0
GSK Investigational Site - Heidelberg
Recruitment postcode(s) [1] 0 0
2298 - Waratah
Recruitment postcode(s) [2] 0 0
7000 - Hobart
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Córdova
Country [3] 0 0
Argentina
State/province [3] 0 0
Santa Fe
Country [4] 0 0
Argentina
State/province [4] 0 0
Quilmes
Country [5] 0 0
Argentina
State/province [5] 0 0
Tucuman
Country [6] 0 0
Austria
State/province [6] 0 0
Salzburg
Country [7] 0 0
Austria
State/province [7] 0 0
Vienna
Country [8] 0 0
Brazil
State/province [8] 0 0
Minas Gerais
Country [9] 0 0
Brazil
State/province [9] 0 0
Rio Grande Do Sul
Country [10] 0 0
Chile
State/province [10] 0 0
Región Metro De Santiago
Country [11] 0 0
Chile
State/province [11] 0 0
Valparaíso
Country [12] 0 0
China
State/province [12] 0 0
Beijing
Country [13] 0 0
Czech Republic
State/province [13] 0 0
Brno
Country [14] 0 0
Czech Republic
State/province [14] 0 0
Chomutov
Country [15] 0 0
Czech Republic
State/province [15] 0 0
Praha 2
Country [16] 0 0
Estonia
State/province [16] 0 0
Tartu
Country [17] 0 0
Italy
State/province [17] 0 0
Lazio
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Seoul
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
songpa-gu, Seoul
Country [20] 0 0
Latvia
State/province [20] 0 0
Riga
Country [21] 0 0
Lithuania
State/province [21] 0 0
Kaunas
Country [22] 0 0
Lithuania
State/province [22] 0 0
Vilnius
Country [23] 0 0
New Zealand
State/province [23] 0 0
Christchurch
Country [24] 0 0
New Zealand
State/province [24] 0 0
Wellington
Country [25] 0 0
Pakistan
State/province [25] 0 0
Karachi
Country [26] 0 0
Pakistan
State/province [26] 0 0
Lahore
Country [27] 0 0
Poland
State/province [27] 0 0
Gdansk
Country [28] 0 0
Poland
State/province [28] 0 0
Krakow
Country [29] 0 0
Poland
State/province [29] 0 0
Kraków
Country [30] 0 0
Poland
State/province [30] 0 0
Olsztyn
Country [31] 0 0
Russian Federation
State/province [31] 0 0
Chelyabinsk
Country [32] 0 0
Russian Federation
State/province [32] 0 0
Kazan
Country [33] 0 0
Russian Federation
State/province [33] 0 0
Moscow
Country [34] 0 0
Russian Federation
State/province [34] 0 0
Omsk
Country [35] 0 0
Russian Federation
State/province [35] 0 0
Samara
Country [36] 0 0
Russian Federation
State/province [36] 0 0
St. Petersburg
Country [37] 0 0
Russian Federation
State/province [37] 0 0
Voronezh
Country [38] 0 0
Russian Federation
State/province [38] 0 0
Yaroslavl
Country [39] 0 0
Slovakia
State/province [39] 0 0
Bratislava
Country [40] 0 0
Tunisia
State/province [40] 0 0
Sfax
Country [41] 0 0
Tunisia
State/province [41] 0 0
Sousse
Country [42] 0 0
Tunisia
State/province [42] 0 0
Tunis
Country [43] 0 0
Ukraine
State/province [43] 0 0
Donetsk
Country [44] 0 0
Ukraine
State/province [44] 0 0
Kharkiv
Country [45] 0 0
Ukraine
State/province [45] 0 0
Kyiv
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Bebington, Wirral
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Belfast, Northern Ireland
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00387764
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries