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

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.

Conditions: Carcinoma, Renal Cell
Being tested: pazopanib
Keywords: renal cell carcinoma, pazopanib, anti-angiogenic therapy, open label
Medical subject headings: Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

pazopanibDrug
800 mg daily dosing continously until progression

Study groups in NCT00387764
Study group	Role	What they receive
pazopanib arm	Experimental	This was a single arm study, therefore no control arm. Receives: Drug: pazopanib

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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)
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.
Measured: From Baseline to Follow-up (up to 6.230 years)
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.
Measured: From Baseline to Follow-up (up to 6.230 years)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: From Baseline to investigational product discontinuation (up to 6.230 years)

Secondary outcomes (6)

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.
Measured: 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)
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.
Measured: From the Baseline to Week 24/investigational product discontinuation (up to 1.65 years)
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.
Measured: From the Baseline to Week 24/investigational product discontinuation (up to 3.460 years)
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.
Measured: 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)
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.
Measured: 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
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.
Measured: From the first dose of study medication to Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2006Oct 2012

First posted13 Oct 2006 (estimated)
Study startSep 2006
Primary completionDec 2009
Study completionOct 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Carcinoma, Renal CellStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00387764
Sponsor's protocol ID: VEG107769
Status last verified: Oct 2013
First submitted: 12 Oct 2006
Last updated: 14 Jan 2014
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Carcinoma, Renal Cell trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00387764
Acronym / sponsor ID: VEG107769
Conditions: Carcinoma, Renal Cell
Keywords: renal cell carcinoma, pazopanib, anti-angiogenic therapy, open label
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Sep 2006
Primary completion: Dec 2009 (actual)
Study completion: Oct 2012 (actual)
First posted: 13 Oct 2006 (estimated)
Results: Posted 3 Dec 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
pazopanib arm	Experimental	Drug: pazopanibThis was a single arm study, therefore no control arm.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (1 listed)

No brain metastasis

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
pazopanib800 mg daily dosing continously until progression	Drug	pazopanib arm

Primary outcome

Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
Time frame: From Baseline to Follow-up (up to 6.230 years)
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.
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)
Time frame: From Baseline to Follow-up (up to 6.230 years)
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.
Number of Participants With Adverse Events Related to Investigational Product
Time frame: From Baseline to Follow-up (up to 6.230 years)
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.
Median Time on Investigational Product
Time frame: From Baseline to investigational product discontinuation (up to 6.230 years)
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.
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
Time frame: From Baseline to investigational product discontinuation (up to 6.230 years)
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.
Number of Participants With the Indicated Worst-case Grade Increase From Baseline for the Indicated Hematology Parameters at Any Time Post-Baseline
Time frame: From Baseline to investigational product discontinuation (up to 6.230 years)
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.
Number of Participants With the Indicated Shift From Baseline in Blood Pressure at Any Time Post-Baseline
Time frame: From Baseline to investigational product discontinuation (up to 6.230 years)
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.
Number of Participants With the Indicated Shift in Heart Rate From Baseline at Any Time Post-Baseline
Time frame: From Baseline to investigational product discontinuation (up to 6.230 years)
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.
Number of Participants With a Change From Baseline to the Indicated Worst-case Post-Baseline Bazett's Heart Rate-corrected QT Interval (QTc) Value
Time frame: From Baseline to investigational product discontinuation (up to 6.230 years)
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.

6 secondary outcomes

Number of Participants With a Complete Response (CR) or Partial Response (PR)
Time frame: 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)
Time frame: From the Baseline to Week 24/investigational product discontinuation (up to 1.65 years)
Number of Participants With the Indicated Best Overall Response
Time frame: From the Baseline to Week 24/investigational product discontinuation (up to 3.460 years)
Progression-free Survival (PFS)
Time frame: 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)
Time frame: 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
Time frame: From the first dose of study medication to Month 12

Results and safety

Results posted to the registry on 3 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pazopanib 800 mg	80	49

Primary outcome: Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)

Time frame: From Baseline to Follow-up (up to 6.230 years). Number. Unit: participants

Measure	Pazopanib 800 mg n = 80
Any AE	78
Any SAE	27

Population analysed: All Treated Participants (ATP) Population: all enrolled participants who received at least one dose of open-label investigational product

Primary outcome: 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)

Time frame: From Baseline to Follow-up (up to 6.230 years). Number. Unit: participants

Measure	Pazopanib 800 mg n = 80
Grade 1	12
Grade 2	33
Grade 3	22
Grade 4	7
Grade 5	4

Population analysed: ATP Population

Primary outcome: Number of Participants With Adverse Events Related to Investigational Product

Time frame: From Baseline to Follow-up (up to 6.230 years). Number. Unit: participants

Measure	Pazopanib 800 mg n = 80
Value	70

Population analysed: ATS Population

Primary outcome: Median Time on Investigational Product

Time frame: From Baseline to investigational product discontinuation (up to 6.230 years). Median (Inter-Quartile Range). Unit: Months

Measure	Pazopanib 800 mg n = 80
Value	9.7 (3.5 to 20.2)

Population analysed: ATS Population

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pazopanib 800 mg	27 of 80 (33.8%)	72 of 80 (90%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

58 sites in 20 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing pazopanib in people with Carcinoma, Renal Cell, run by GlaxoSmithKline at 58 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in Russia, Argentina, Poland, Tunisia, Australia and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) (time frame: From Baseline to Follow-up (up to 6.230 years)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00387764.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2014.