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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00387764