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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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) - An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in other situations.
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) - An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in other situations. Adverse events were graded for severity according to the NCI CTCAE, version 3.0: Grade 1, mild; Grade 2, moderate; Grade 3 (G3), severe; Grade 4 (G4), life-threatening or disabling; Grade 5, death.
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 - An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The investigator assessed relatedness between the AE and the 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 - The time on investigational product (including dose interruptions) is defined as the difference between the date of the last dose of investigational product and the date of the first dose of investigational product plus one.
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 - Clinical chemistry parameters were summarized according to NCI CTCAE, version 4.0: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; Grade 5, death. Data are presented for only those parameters for which an increase from Baseline occurred. Clinical chemistry parameters included: alkaline phosphatase (ALP), alanine amino transferase (ALT), aspartate amino transferase (AST), total bilirubin (TB), calcium (hypercalcemia and hypocalcemia), creatinine, glucose (hyperglycemia and hypoglycemia), potassium (hyperkalemia and hypokalemia), magnesium (hypermagnesemia and hypomagnesemia), sodium (hypernatremia and hyponatremia), and phosphate.
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 - Hematology parameters were summarized according to NIH CTCAE, version 4.0. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; Grade 5, death. Data are presented for only those parameters for which an increase from Baseline occurred. Hematology parameters included: hemoglobin (anemia), lymphocytes (lymphocytopenia), neutrophils (neutropenia), platelets (thrombocytopenia), white blood cells (WBC [leukopenia]), and prothrombin time international normalized ratio (PT [INR]). Participants with missing Baseline grades are assumed to have a Baseline grade of 0.
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 - Blood pressure measurements included systolic blood pressure (SBP, millimeters of mercury [mmHg]) and diastolic BP (DBP). The number of participants with a post-Baseline shift from Baseline in blood pressure (<90 mmHg, 90 to 139 mmHg, 140 to 169 mmHg, >=170 mmHg) was assessed.
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 - Heart rate is the measure of heart beats per minute (bpm). The number of participants with a post-Baseline shift from Baseline in heart rate of <44 bpm, 44 to 100 bpm, 101 to 120 bpm, and >120 bpm was assessed.
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 - The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. A lengthened QT interval can be a biomarker for ventricular tachyarrhythmias. The QT interval corrected for heart rate using Bazett's formula (QTcB) was calculated; the faster the heart rate, the shorter the QT interval. Electrocardiogram values (Bazett's QTc value) were summarized using the following reference ranges: <450, 450 to 479, 480 to 499, 500 to 549, and >550 milliseconds.
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) - Overall tumor response is defined as the number of participants achieving either a confirmed complete or partial tumor response per Response Evaluation Criteria in Solid Tumors (RECIST). RECIST guidelines were used to evaluate the measurability of tumor lesions, to determine target and non-target lesions at Baseline, and to evaluate tumor response or disease progression after study start. CR is defined as the disappearance of all target and non-target lesions, and PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions, taking as a reference the Baseline sum LD, as assessed by the investigator. Confirmation of a CR/PR required a subsequent assessment of the same response or better at least 28 days after the original response.
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) - The number of participants who achieved either a CR, a PR, or a best response of SD that occurred at least 6 months after screening per RECIST criteria was assessed. CR is defined as the disappearance of all target and non-target lesions; PR is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD; and SD is defined as neither sufficient shrinkage in target lesions to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started and the persistence of one or more non-target lesion(s), as assessed by the investigator. Confirmation of a CR/PR required a subsequent assessment of the same response or better at least 28 days after the original response. A confirmed response of SD required that the SD assessment occurred no earlier than 12 weeks after the screening scans.
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 - The best overall response is defined as the best response recorded from the start of the treatment until disease progression (PD)/recurrence. Per RECIST: CR, the disappearance of all target and non-target lesions; PR, at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD; SD, neither sufficient shrinkage in target lesions to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started and the persistence of one or more non-target lesion(s); PD, at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum of the LD recorded since the treatment started or the appearance of >=1 new lesion and/or unequivocal progression of existing non-target lesions. Unknown/not evaluable is used for those participants who cannot be classified as achieving CR, PR, SD, or PD.
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) - PFS is defined as the interval between the date of the first dose of study medication and the date of disease progression as defined by the investigator or death due to any cause. RECIST was used to evaluate the measurability of tumor lesions, to determine target and non-target lesions at Baseline, and to evaluate tumor response or disease progression after study start. Per RECIST, PD is defined as at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum of the LD recorded since the treatment started or the appearance of >=1 new lesion and/or unequivocal progression of existing non-target lesions. Participants who did not have disease progression or did not die were censored at the follow-up visit as either follow-up ended or follow-up ongoing. Participants who received non-study anti-cancer therapies before disease progression were treated as censored.
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) - OS is defined as the interval between the date of the first dose of study medication to the date of death due to any cause. For participants who did not die, time to death was censored at the time of last contact. The last date of contact was defined as the maximum date of any visit date or the survival follow-up date.
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 - For participants who did not die, time to death was censored at the time of last contact. The last date of contact was defined as the maximum date of any visit date or the survival follow-up date.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/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

Summary results
Other publications