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Efficacy and Safety of Pazopanib Monotherapy After First-line Chemotherapy in Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Asian Women

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ClinicalTrials.gov Identifier: NCT01227928
Recruitment Status : Completed
First Posted : October 25, 2010
Results First Posted : June 4, 2013
Last Update Posted : March 3, 2015
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Neoplasms, Ovarian
Interventions Drug: Pazopanib
Drug: Placebo comparator
Enrollment 145
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Pazopanib 800 Milligrams
Hide Arm/Group Description Participants received matching placebo administered orally once daily for up to 24 months. Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
Period Title: Overall Study
Started 72 73
Completed 50 56
Not Completed 22 17
Reason Not Completed
Lost to Follow-up             4             2
Withdrawal by Subject             4             3
Death             14             12
Arm/Group Title Placebo Pazopanib 800 Milligrams Total
Hide Arm/Group Description Participants received matching placebo administered orally once daily for up to 24 months. Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months. Total of all reporting groups
Overall Number of Baseline Participants 72 73 145
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 72 participants 73 participants 145 participants
54.1  (10.46) 51.7  (9.62) 52.9  (10.09)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 73 participants 145 participants
Female
72
 100.0%
73
 100.0%
145
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Asian Number Analyzed 72 participants 73 participants 145 participants
72 73 145
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description PFS is defined as the time interval between randomization and evidence of progressive disease (PD), as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, or death, whichever occurred first. A visit-based analysis approach to determine participants’ dates of progression was applied in the analysis method. PD is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Participants who were alive and had not progressed at the time of analysis were censored at the date associated with the last visit with adequate assessment.
Time Frame From randomization until evidence of progressive disease or death, whichever occurred first (average of 15.2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all randomized participants who were not screen failures. Participants who were screen failures and randomized by mistake, but who did not receive study treatment, were not included. The treatment assignment in the ITT Population was based on the randomized treatment. The data cut off was October 12, 2012.
Arm/Group Title Placebo Pazopanib 800 Milligrams
Hide Arm/Group Description:
Participants received matching placebo administered orally once daily for up to 24 months.
Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
Overall Number of Participants Analyzed 72 73
Median (95% Confidence Interval)
Unit of Measure: months
18.1 [1] 
(12.1 to NA)
18.1
(18.0 to 18.1)
[1]
The lower and upper bounds of the confidence intervals were calculated when there was a sufficient number of events (progressions or deaths).
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pazopanib 800 Milligrams
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.984
Confidence Interval (2-Sided) 95%
0.595 to 1.626
Estimation Comments The Hazard Ratio (HR) is estimated using a Pike estimator. The HR was adjusted for the stratification factor of first-line treatment outcome.
2.Secondary Outcome
Title Overall Survival
Hide Description Overall survival is defined as the time interval from the date of randomization to the date of death due to any cause.
Time Frame From randomization until death due to any cause (average of 29.4 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants who were alive as of study completion were censored at the last contact date. The cut off for these data was January 10, 2014.
Arm/Group Title Placebo Pazopanib 800 Milligrams
Hide Arm/Group Description:
Participants received matching placebo administered orally once daily for up to 24 months.
Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
Overall Number of Participants Analyzed 72 73
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
There were too few events of death for median overall survival or the 95% confidence interval to be reached.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pazopanib 800 Milligrams
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5901
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.811
Confidence Interval (2-Sided) 95%
0.376 to 1.751
Estimation Comments The Hazard Ratio (HR) is estimated using a Pike estimator. The HR was adjusted for the three stratification factors.
3.Secondary Outcome
Title PFS by Gynaecologic Cancer Intergroup (GCIG) Criteria
Hide Description PFS by GCIG criteria is defined as the time from the randomization date to the earliest date of disease progression (PD) per GCIG criteria or death due to any cause. Per GCIG criteria, an objective progression is defined as the earliest event of either tumor progression based on RECIST v1.0 or confirmed CA-125 progression. A participant is counted as "Progressed per RECIST" if the radiological PD per RECIST occurred prior to or on the same day as CA-125 progression. A participant is counted as "Progressed per CA-125" if the radiological PD occurred after CA-125 progression. 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 LD recorded since the treatment started or the appearance of one or more new lesions. Participants who were alive and had not progressed at the time of analysis were censored at the date associated with the last visit with adequate assessment.
Time Frame From randomization to the earliest date of disease progression per GCIG criteria or death due to any cause (average of 15.2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. The cut off for these data was October 12, 2012.
Arm/Group Title Placebo Pazopanib 800 Milligrams
Hide Arm/Group Description:
Participants received matching placebo administered orally once daily for up to 24 months.
Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
Overall Number of Participants Analyzed 72 73
Median (95% Confidence Interval)
Unit of Measure: months
15.2 [1] 
(9.0 to NA)
16.1
(14.2 to 18.2)
[1]
The lower and upper bounds of the confidence intervals were calculated when there was a sufficient number of events (progressions or deaths).
4.Secondary Outcome
Title Number of Participants With Any Dose Reduction or Any Dose Interruption
Hide Description Dose interruptions or reductions may have been required following potential drug-related toxicities. As a general rule, if dose reduction of investigational product (IP) was necessary, the dose should have been reduced stepwise by 200 mg at each step, and the participant should have been monitored for 10 to 14 days. If toxicity recurred or worsened during this monitoring time, the IP could have been interrupted and/or the dose of IP further decreased, with continued monitoring for an additional 10 to 14 days, and so on. The cut off for these data was October 12, 2012.
Time Frame From Week 1 until the end of the treatment period (up to Study Week 108)
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment.
Arm/Group Title Placebo Pazopanib 800 Milligrams
Hide Arm/Group Description:
Participants received matching placebo administered orally once daily for up to 24 months.
Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
Overall Number of Participants Analyzed 72 72
Measure Type: Number
Unit of Measure: participants
Any Reduction 26 64
Any Interruption 44 65
5.Secondary Outcome
Title Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE)
Hide Description An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalizaton or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. See the non-serious AE/SAE module for a list of specific events.
Time Frame From Week 1 until the end of the treatment period (up to Study Week 108)
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014.
Arm/Group Title Placebo Pazopanib 800 Milligrams
Hide Arm/Group Description:
Participants received matching placebo administered orally once daily for up to 24 months.
Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
Overall Number of Participants Analyzed 72 72
Measure Type: Number
Unit of Measure: participants
Any AE 65 72
Any SAE 4 7
6.Secondary Outcome
Title Number of Participants With Any On-therapy AE and Any AE Related to Study Treatment
Hide Description An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. On-therapy AEs were those reported from the first day that randomized study drug was received to 28 days after the last dose of randomized study drug, and within 28 days of dose interruption. Relatedness was assessed by the Investigator.
Time Frame From Week 1 until the end of the treatment period (up to Study Week 108)
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014.
Arm/Group Title Placebo Pazopanib 800 Milligrams
Hide Arm/Group Description:
Participants received matching placebo administered orally once daily for up to 24 months.
Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
Overall Number of Participants Analyzed 72 72
Measure Type: Number
Unit of Measure: participants
Any on-therapy AE 65 72
Any AE related to study treatment 52 71
7.Secondary Outcome
Title Number of Participants With Any Grade 3 or 4 AE
Hide Description An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. The NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 3.0 was used to grade AEs per the following scale to assess severity: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling AE; Grade 5, death related to AE.
Time Frame From Week 1 until the end of the treatment period (up to Study Week 108)
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014.
Arm/Group Title Placebo Pazopanib 800 Milligrams
Hide Arm/Group Description:
Participants received matching placebo administered orally once daily for up to 24 months.
Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
Overall Number of Participants Analyzed 72 72
Measure Type: Number
Unit of Measure: participants
8 39
8.Secondary Outcome
Title Number of Participants With the Indicated On-therapy Grade 3-5 AEs
Hide Description An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. On-therapy AEs were those reported from the first day that randomized study drug was received to 28 days after the last dose of randomized study drug, and within 28 days of dose interruption. The NCI-CTCAE Version 3.0 was used to grade AEs per the following scale to assess severity: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling AE; Grade 5, death related to AE. ALT=alanine aminotransferase; AST=aspartate aminotransferase.
Time Frame From Week 1 until the end of the treatment period (up to Study Week 108)
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014.
Arm/Group Title Placebo Pazopanib 800 Milligrams
Hide Arm/Group Description:
Participants received matching placebo administered orally once daily for up to 24 months.
Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
Overall Number of Participants Analyzed 72 72
Measure Type: Number
Unit of Measure: participants
Hypertension, Grade 3 1 13
Neutropenia, Grade 3 0 9
Leukopenia, Grade 3 0 1
Diarrhea, Grade 3 1 5
ALT increased, Grade 3 0 1
Thrombocytopenia, Grade 3 0 3
AST increased, Grade 3 0 1
Neutrophil count decreased, Grade 3 0 2
Neutrophil count decreased, Grade 4 0 1
Arthralgia, Grade 3 0 1
Upper respiratory tract infection, Grade 3 1 0
Protein urine, Grade 3 0 1
Proteinuria, Grade 3 0 1
Bone pain, Grade 3 0 1
Toothache, Grade 3 0 1
Pyrexia, Grade 3 1 0
Hepatic function abnormal, Grade 3 0 1
Liver injury, Grade 3 0 1
Abdominal distension, Grade 3 1 0
Bradycardia, Grade 3 0 1
Febrile neutropenia, Grade 3 0 1
Thrombus in device, Grade 3 0 1
Pruritis, Grade 3 1 0
Amylase increased, Grade 3 1 0
Cerebral ischaemia, Grade 3 1 0
Foot fracture, Grade 3 1 0
9.Secondary Outcome
Title Number of Participants With AEs Leading to Permanent Discontinuation of Study Treatment, Dose Interruption, and Dose Reduction
Hide Description An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Dose interruptions or reductions may have been required following potential drug-related toxicities. As a general rule, if dose reduction of investigational product (IP) was necessary, the dose should have been reduced stepwise by 200 mg at each step, and the participant should have been monitored for 10 to 14 days. If toxicity recurred or worsened during this monitoring time, the IP could have been interrupted and/or the dose of IP further decreased, with continued monitoring for an additional 10 to 14 days, and so on.
Time Frame From Week 1 until the end of the treatment period (up to Study Week 108)
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014.
Arm/Group Title Placebo Pazopanib 800 Milligrams
Hide Arm/Group Description:
Participants received matching placebo administered orally once daily for up to 24 months.
Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
Overall Number of Participants Analyzed 72 72
Measure Type: Number
Unit of Measure: participants
Permanent discontinuation 1 18
Dose interruption 29 67
Dose reduction 24 63
10.Secondary Outcome
Title Number of Participants With Any SAE, Any SAE Related to Study Treatment, and Any Fatal SAE
Hide Description An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalizaton or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. See the non-serious AE/SAE module for a list of specific events. Relatedness was assessed by the Investigator.
Time Frame From Week 1 until the end of the treatment period (up to Study Week 108)
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014.
Arm/Group Title Placebo Pazopanib 800 Milligrams
Hide Arm/Group Description:
Participants received matching placebo administered orally once daily for up to 24 months.
Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
Overall Number of Participants Analyzed 72 72
Measure Type: Number
Unit of Measure: participants
Any SAE 4 7
Any SAE related to study treatment 1 4
Any fatal SAE 0 0
11.Secondary Outcome
Title Number of Participants With the Indicated Worst-case On-therapy Blood Pressure Shifts From Baseline
Hide Description Systolic blood pressure (SBP) and Diatolic blood pressure (DBP) are measured in millimeters of mercury (mmHg). A participant could have been counted in more than one shift category. Participants who experienced shifts in both SBP and DBP are represented under each individual parameter. A worst-case on-therapy shift is defined as the worst shift that occurred at any time during the treatment period.
Time Frame From Week 1 until the end of the treatment period (up to Study Week 108)
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population. One participant on placebo did not report any blood pressure measurements post-Baseline. The cut off for these data was January 10, 2014.
Arm/Group Title Placebo Pazopanib 800 Milligrams
Hide Arm/Group Description:
Participants received matching placebo administered orally once daily for up to 24 months.
Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
Overall Number of Participants Analyzed 71 72
Measure Type: Number
Unit of Measure: participants
SBP, Any increase to >=120 mmHg 28 53
SBP, Increase to 140-<160 mmHg 4 23
SBP, Increase to >=160 mmHg 0 6
DBP, Any increase to >=80 mmHg 35 59
DBP, Increase to 90-<100 mmHg 1 25
DBP, Increase to >=100 mmHg 0 5
12.Secondary Outcome
Title Number of Participants With the Indicated Worst-case On-therapy Shift From Baseline in Bazett's Corrected QT Interval (QTc)
Hide Description 12-lead ECGs were obtained at the scheduled visits. A worst-case on-therapy shift is defined as the worst shift that occurred at any time during the treatment period. The QTc 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. In general, the faster the heart rate the shorter the QTc. If a QTc >=500 milliseconds (msec) was noted on a scheduled or unscheduled electrocardiogram (ECG), then two additional ECGs should have been obtained within 5 minutes to confirm the abnormality. The average QTc was determined from the three ECG tracings by manual evaluation and was used to determine continued eligibility.
Time Frame From Week 1 until the end of the treatment period (up to Study Week 108)
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population. Only those participants for which a post-Baseline ECG was conducted were analyzed. The cut off for these data was October 12, 2012.
Arm/Group Title Placebo Pazopanib 800 Milligrams
Hide Arm/Group Description:
Participants received matching placebo administered orally once daily for up to 24 months.
Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
Overall Number of Participants Analyzed 69 70
Measure Type: Number
Unit of Measure: participants
Any increase to >=450 msec 10 5
Increase to 481-500 msec 1 1
Increase to >=501 msec 2 0
13.Secondary Outcome
Title Number of Participants With the Indicated Worst-case On-therapy Hematology Parameter Grade Shifts From Baseline Grade
Hide Description Grade shifts from Baseline were assessed as any grade increase (AGI), increase to Grade (G) 3 (ITG3), and increase to Grade 4 (ITG4). Toxicities were graded according to the National Cancer Institute common toxicity criteria (NCI-Common Toxicity Criteria for Adverse Events), version 4.0. Grade refers to the severity of the toxicity. The CTCAE displays Grades (G) 1 through 5 with unique clinical descriptions of severity for each toxicity based on the following general guideline: G1, mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; G2, moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL); G3, severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; G4, Life-threatening consequences; urgent intervention indicated.; G5, death related to AE.
Time Frame From Week 1 until the end of the treatment period (up to Study Week 108)
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population. Data are presented for only those participants with laboratory values. The cut off for these data was October 12, 2012.
Arm/Group Title Placebo Pazopanib 800 Milligrams
Hide Arm/Group Description:
Participants received matching placebo administered orally once daily for up to 24 months.
Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
Overall Number of Participants Analyzed 69 71
Measure Type: Number
Unit of Measure: participants
Hemoglobin, AGI 4 14
Hemoglobin, ITG3 0 0
Hemoglobin, ITG4 0 0
Lymphocytes, AGI 11 9
Lymphocytes, ITG3 2 1
Lymphocytes, ITG4 0 0
Neutrophils, AGI 22 55
Neutrophils, ITG3 0 11
Neutrophils, ITG4 0 2
Platelets, AGI 10 32
Platelets, ITG3 0 1
Platelets, ITG4 0 0
White blood cells, AGI 19 48
White blood cells, ITG3 0 2
White blood cells, ITG4 0 0
14.Secondary Outcome
Title Number of Participants With the Indicated Worst-case On-therapy Chemistry Parameter Grade Shifts From Baseline Grade
Hide Description Grade shifts from Baseline were assessed as any grade increase (AGI), increase to Grade (G) 3 (ITG3), and increase to Grade 4 (ITG4). Toxicities were graded according to the National Cancer Institute common toxicity criteria (NCI-Common Toxicity Criteria for Adverse Events), version 4.0. Grade refers to the severity of the toxicity. The CTCAE displays Grades (G) 1 through 5 with unique clinical descriptions of severity for each toxicity based on the following general guideline: G1, mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; G2, moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL); G3, severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; G4, Life-threatening consequences; urgent intervention indicated.; G5, death related to AE.
Time Frame From Week 1 until the end of the treatment period (up to Study Week 108)
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population. Data are presented for only those participants with laboratory values. The cut off for these data was October 12, 2012.
Arm/Group Title Placebo Pazopanib 800 Milligrams
Hide Arm/Group Description:
Participants received matching placebo administered orally once daily for up to 24 months.
Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
Overall Number of Participants Analyzed 69 70
Measure Type: Number
Unit of Measure: participants
Albumin, AGI, n=69, 70 2 1
Albumin, ITG3, n=69, 70 0 0
Albumin, ITG4, n=69, 70 0 0
Creatinine, AGI, n=69, 70 2 2
Creatinine, ITG3, n=69, 70 0 1
Creatinine, ITG4, n=69, 70 0 0
Hypercalcemia, AGI, n=69, 69 9 3
Hypercalcemia, ITG3, n=69, 69 1 0
Hypercalcemia, ITG4, n=69, 69 0 0
Hyperglycemia, AGI, n=69, 70 16 14
Hyperglycemia, ITG3, n=69, 70 0 0
Hyperglycemia, ITG4, n=69, 70 0 0
Hyperkalemia, AGI, n=69, 70 0 1
Hyperkalemia, ITG3, n=69, 70 0 0
Hyperkalemia, ITG4, n=69, 70 0 0
Hypermagnesemia, AGI, n=69, 69 6 2
Hypermagnesemia, ITG3, n=69, 69 1 1
Hypermagnesemia, ITG4, n=69, 69 0 0
Hypernatremia, AGI, n=69, 70 2 3
Hypernatremia, ITG3, n=69, 70 0 0
Hypernatremia, ITG4, n=69, 70 0 0
Hypocalcemia, AGI, n=69, 69 4 5
Hypocalcemia, ITG3, n=69, 69 0 0
Hypocalcemia, ITG4, n=69, 69 0 0
Hypoglycemia, AGI, n=69, 70 0 3
Hypoglycemia, ITG3, n=69, 70 0 0
Hypoglycemia, ITG4, n=69, 70 0 0
Hypokalemia, AGI, n=69, 70 10 6
Hypokalemia, ITG3, n=69, 70 0 0
Hypokalemia, ITG4, n=69, 70 0 0
Hypomagnesemia, AGI, n=69, 69 6 2
Hypomagnesemia, ITG3, n=69, 69 0 0
Hypomagnesemia, ITG4, n=69, 69 0 0
Hyponatremia, AGI, n=69, 70 1 1
Hyponatremia, ITG3, n=69, 70 0 0
Hyponatremia, ITG4, n=69, 70 0 0
Phosphate, AGI, n=69, 69 2 4
Phosphate, ITG3, n=69, 69 0 0
Phosphate, ITG4, n=69, 69 0 0
15.Secondary Outcome
Title Number of Participants With the Indicated Worst-case Eastern Cooperative Oncology Group (ECOG) Performance Status Shifts From Baseline Grades of 0, 1, and 2
Hide Description The ECOG performance status scales and criteria are used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living abilities of the participant, and determine appropriate treatment and prognosis. Grade 0, fully active, able to carry on all pre-disease performance without restriction. Grade 1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. Grade 2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about more than 50% of waking hours. Grade 3, capable of only limited selfcare; confined to bed or chair more than 50% of waking hours. Grade 4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair. Grade 5, dead.
Time Frame From Week 1 until the end of the treatment period (up to Study Week 108)
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population. The cut off for these data was October 12, 2012.
Arm/Group Title Placebo Pazopanib 800 Milligrams
Hide Arm/Group Description:
Participants received matching placebo administered orally once daily for up to 24 months.
Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
Overall Number of Participants Analyzed 72 72
Measure Type: Number
Unit of Measure: participants
Baseline score of 0; shift to 0 56 46
Baseline score of 0; shift to 1 2 13
Baseline score of 0; shift to 2 0 0
Baseline score of 1; shift to 0 0 0
Baseline score of 1; shift to 1 12 13
Baseline score of 1; shift to 2 1 0
Baseline score of 2; shift to 0 0 0
Baseline score of 2; shift to 1 0 0
Baseline score of 2; shift to 2 1 0
Time Frame [Not Specified]
Adverse Event Reporting Description Serious adverse events (SAEs) and non-serious AEs were collected in members of the All Treated Population, comprised of all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment.
 
Arm/Group Title Placebo Pazopanib 800 Milligrams
Hide Arm/Group Description Participants received matching placebo administered orally once daily for up to 24 months. Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
All-Cause Mortality
Placebo Pazopanib 800 Milligrams
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Pazopanib 800 Milligrams
Affected / at Risk (%) Affected / at Risk (%)
Total   4/72 (5.56%)   7/72 (9.72%) 
Blood and lymphatic system disorders     
Febrile neutropenia  1  0/72 (0.00%)  1/72 (1.39%) 
Gastrointestinal disorders     
Ileus paralytic  1  0/72 (0.00%)  1/72 (1.39%) 
Salivary gland calculus  1  0/72 (0.00%)  1/72 (1.39%) 
General disorders     
Thrombosis in device  1  0/72 (0.00%)  1/72 (1.39%) 
Hepatobiliary disorders     
Hepatic function abnormal  1  0/72 (0.00%)  1/72 (1.39%) 
Liver injury  1  0/72 (0.00%)  1/72 (1.39%) 
Infections and infestations     
Urinary tract infection  1  1/72 (1.39%)  0/72 (0.00%) 
Injury, poisoning and procedural complications     
Foot fracture  1  1/72 (1.39%)  0/72 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  0/72 (0.00%)  1/72 (1.39%) 
Aspartate aminotransferase increased  1  0/72 (0.00%)  1/72 (1.39%) 
Neutrophil count decreased  1  0/72 (0.00%)  1/72 (1.39%) 
Nervous system disorders     
Cerebral artery stenosis  1  1/72 (1.39%)  0/72 (0.00%) 
Cerebral ischaemia  1  1/72 (1.39%)  0/72 (0.00%) 
Vascular disorders     
Hypertension  1  1/72 (1.39%)  0/72 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA, version 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Pazopanib 800 Milligrams
Affected / at Risk (%) Affected / at Risk (%)
Total   59/72 (81.94%)   72/72 (100.00%) 
Blood and lymphatic system disorders     
Neutropenia  1  16/72 (22.22%)  46/72 (63.89%) 
Leukopenia  1  18/72 (25.00%)  39/72 (54.17%) 
Thrombocytopenia  1  4/72 (5.56%)  17/72 (23.61%) 
Gastrointestinal disorders     
Diarrhoea  1  5/72 (6.94%)  35/72 (48.61%) 
Abdominal pain  1  5/72 (6.94%)  11/72 (15.28%) 
Nausea  1  3/72 (4.17%)  11/72 (15.28%) 
Abdominal pain upper  1  2/72 (2.78%)  9/72 (12.50%) 
Dyspepsia  1  5/72 (6.94%)  3/72 (4.17%) 
Abdominal discomfort  1  4/72 (5.56%)  2/72 (2.78%) 
Abdominal distension  1  4/72 (5.56%)  2/72 (2.78%) 
General disorders     
Fatigue  1  8/72 (11.11%)  14/72 (19.44%) 
Chest discomfort  1  3/72 (4.17%)  4/72 (5.56%) 
Pyrexia  1  4/72 (5.56%)  3/72 (4.17%) 
Infections and infestations     
Nasopharyngitis  1  9/72 (12.50%)  9/72 (12.50%) 
Upper respiratory tract infection  1  5/72 (6.94%)  6/72 (8.33%) 
Urinary tract infection  1  6/72 (8.33%)  5/72 (6.94%) 
Investigations     
Alanine aminotransferase increased  1  4/72 (5.56%)  19/72 (26.39%) 
Aspartate aminotransferase increased  1  6/72 (8.33%)  16/72 (22.22%) 
Blood thyroid stimulating hormone increased  1  2/72 (2.78%)  15/72 (20.83%) 
Blood lactate dehydrogenase increased  1  2/72 (2.78%)  7/72 (9.72%) 
Neutrophil count decreased  1  2/72 (2.78%)  6/72 (8.33%) 
Blood bilirubin increased  1  1/72 (1.39%)  5/72 (6.94%) 
Protein urine present  1  1/72 (1.39%)  6/72 (8.33%) 
Electrocardiogram QT prolonged  1  4/72 (5.56%)  0/72 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  1/72 (1.39%)  8/72 (11.11%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  4/72 (5.56%)  7/72 (9.72%) 
Pain in extremity  1  3/72 (4.17%)  4/72 (5.56%) 
Back pain  1  2/72 (2.78%)  5/72 (6.94%) 
Myalgia  1  5/72 (6.94%)  2/72 (2.78%) 
Nervous system disorders     
Headache  1  5/72 (6.94%)  13/72 (18.06%) 
Dizziness  1  3/72 (4.17%)  10/72 (13.89%) 
Psychiatric disorders     
Insomnia  1  5/72 (6.94%)  2/72 (2.78%) 
Renal and urinary disorders     
Proteinuria  1  0/72 (0.00%)  4/72 (5.56%) 
Skin and subcutaneous tissue disorders     
Hair colour changes  1  1/72 (1.39%)  29/72 (40.28%) 
Palmar-plantar erythrodysaesthesia syndrome  1  2/72 (2.78%)  21/72 (29.17%) 
Rash  1  8/72 (11.11%)  4/72 (5.56%) 
Vascular disorders     
Hypertension  1  20/72 (27.78%)  55/72 (76.39%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA, version 15.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01227928     History of Changes
Other Study ID Numbers: 114012
First Submitted: October 21, 2010
First Posted: October 25, 2010
Results First Submitted: April 18, 2013
Results First Posted: June 4, 2013
Last Update Posted: March 3, 2015