A Phase 2 interventional study of Pazopanib and Placebo comparator in Neoplasms, Ovarian, sponsored by GlaxoSmithKline. Completed at 15 sites in 4 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-03.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment
This is a study to determine whether therapy with pazopanib is effective and safe in Asian women with epithelial ovarian, fallopian tube or primary peritoneal cancer whose cancer has not progressed on first-line chemotherapy.
This study is an extension study to the VEG110655 study. The parent study, VEG110655, was designed to evaluate whether pazopanib 800 mg daily for 52 weeks will prolong progression free survival (PFS) in women diagnosed with ovarian, fallopian tube or primary peritoneal cancer. These women will have obtained stable disease, a complete remission, or a partial remission after debulking surgery and at least five cycles of chemotherapy (taxane/platinum). This extension study will evaluate safety and efficacy outcomes of pazopanib monotherapy and placebo in an Asian population with the same indication as the parent study.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's enrollment of 145 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Hematologic
Or, if greater than 1.5 mg/dL:
Calculated creatinine clearance at least 50 mL/min Urine Protein
Exclusion Criteria:
experimental medication
Drug: Pazopanib
placebo comparator
Drug: Placebo comparator
Pazopanib 800 mg daily for 24 months
Placebo 800 mg daily for 24 months
Progression-free Survival (PFS)
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)
Overall Survival
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)
PFS by Gynaecologic Cancer Intergroup (GCIG) Criteria
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)
Number of Participants With Any Dose Reduction or Any Dose Interruption
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)
Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE)
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)
Number of Participants With Any On-therapy AE and Any AE Related to Study Treatment
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)
Number of Participants With Any Grade 3 or 4 AE
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)
Number of Participants With the Indicated On-therapy Grade 3-5 AEs
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)
Number of Participants With AEs Leading to Permanent Discontinuation of Study Treatment, Dose Interruption, and Dose Reduction
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)
Number of Participants With Any SAE, Any SAE Related to Study Treatment, and Any Fatal SAE
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)
Number of Participants With the Indicated Worst-case On-therapy Blood Pressure Shifts From Baseline
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)
Number of Participants With the Indicated Worst-case On-therapy Shift From Baseline in Bazett's Corrected QT Interval (QTc)
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)
Number of Participants With the Indicated Worst-case On-therapy Hematology Parameter Grade Shifts From Baseline Grade
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)
Number of Participants With the Indicated Worst-case On-therapy Chemistry Parameter Grade Shifts From Baseline Grade
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)
Number of Participants With the Indicated Worst-case Eastern Cooperative Oncology Group (ECOG) Performance Status Shifts From Baseline Grades of 0, 1, and 2
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)
| Milestone | Placebo | Pazopanib 800 Milligrams |
|---|---|---|
| Started | 72 | 73 |
| Completed | 50 | 56 |
| Not completed | 22 | 17 |
| Withdrew: Lost to follow-up | 4 | 2 |
| Withdrew: Withdrawal by subject | 4 | 3 |
| Withdrew: Death | 14 | 12 |
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.
| months | Placebo | Pazopanib 800 Milligrams |
|---|---|---|
| Progression-free Survival (PFS) | 18.1 (12.1 to NA) | 18.1 (18.0 to 18.1) |
Overall survival is defined as the time interval from the date of randomization to the date of death due to any cause.
| months | Placebo | Pazopanib 800 Milligrams |
|---|---|---|
| Overall Survival | NA (NA to NA) | NA (NA to NA) |
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.
| months | Placebo | Pazopanib 800 Milligrams |
|---|---|---|
| PFS by Gynaecologic Cancer Intergroup (GCIG) Criteria | 15.2 (9.0 to NA) | 16.1 (14.2 to 18.2) |
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.
| participants | Placebo | Pazopanib 800 Milligrams |
|---|---|---|
| Any Reduction | 26 | 64 |
| Any Interruption | 44 | 65 |
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.
| participants | Placebo | Pazopanib 800 Milligrams |
|---|---|---|
| Any AE | 65 | 72 |
| Any SAE | 4 | 7 |
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.
| participants | Placebo | Pazopanib 800 Milligrams |
|---|---|---|
| Any on-therapy AE | 65 | 72 |
| Any AE related to study treatment | 52 | 71 |
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.
| participants | Placebo | Pazopanib 800 Milligrams |
|---|---|---|
| Number of Participants With Any Grade 3 or 4 AE | 8 | 39 |
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.
| participants | Placebo | Pazopanib 800 Milligrams |
|---|---|---|
| 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 |
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.
| participants | Placebo | Pazopanib 800 Milligrams |
|---|---|---|
| Permanent discontinuation | 1 | 18 |
| Dose interruption | 29 | 67 |
| Dose reduction | 24 | 63 |
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.
| participants | Placebo | Pazopanib 800 Milligrams |
|---|---|---|
| Any SAE | 4 | 7 |
| Any SAE related to study treatment | 1 | 4 |
| Any fatal SAE | 0 | 0 |
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.
| participants | Placebo | Pazopanib 800 Milligrams |
|---|---|---|
| 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-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.
| participants | Placebo | Pazopanib 800 Milligrams |
|---|---|---|
| Any increase to >=450 msec | 10 | 5 |
| Increase to 481-500 msec | 1 | 1 |
| Increase to >=501 msec | 2 | 0 |
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.
| participants | Placebo | Pazopanib 800 Milligrams |
|---|---|---|
| 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 |
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.
| participants | Placebo | Pazopanib 800 Milligrams |
|---|---|---|
| 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 |
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.
| participants | Placebo | Pazopanib 800 Milligrams |
|---|---|---|
| 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 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 4/72 (5.6%) | 59/72 (81.9%) |
| Pazopanib 800 Milligrams | — | 7/72 (9.7%) | 72/72 (100%) |
| Event | Placebo | Pazopanib 800 Milligrams |
|---|---|---|
| Ileus paralyticGastrointestinal disorders | 0/72 | 1/72 |
| Salivary gland calculusGastrointestinal disorders | 0/72 | 1/72 |
| Hepatic function abnormalHepatobiliary disorders | 0/72 | 1/72 |
| Liver injuryHepatobiliary disorders | 0/72 | 1/72 |
| Febrile neutropeniaBlood and lymphatic system disorders | 0/72 | 1/72 |
| Thrombosis in deviceGeneral disorders | 0/72 | 1/72 |
| Alanine aminotransferase increasedInvestigations | 0/72 | 1/72 |
| Aspartate aminotransferase increasedInvestigations | 0/72 | 1/72 |
| Neutrophil count decreasedInvestigations | 0/72 | 1/72 |
| Urinary tract infectionInfections and infestations | 1/72 | 0/72 |
| Event | Placebo | Pazopanib 800 Milligrams |
|---|---|---|
| HypertensionVascular disorders | 20/72 | 55/72 |
| NeutropeniaBlood and lymphatic system disorders | 16/72 | 46/72 |
| LeukopeniaBlood and lymphatic system disorders | 18/72 | 39/72 |
| DiarrhoeaGastrointestinal disorders | 5/72 | 35/72 |
| Hair colour changesSkin and subcutaneous tissue disorders | 1/72 | 29/72 |
| Palmar-plantar erythrodysaesthesia syndromeSkin and subcutaneous tissue disorders | 2/72 | 21/72 |
| Alanine aminotransferase increasedInvestigations | 4/72 | 19/72 |
| ThrombocytopeniaBlood and lymphatic system disorders | 4/72 | 17/72 |
| Aspartate aminotransferase increasedInvestigations | 6/72 | 16/72 |
| Blood thyroid stimulating hormone increasedInvestigations | 2/72 | 15/72 |
| Age, Continuous(Years) | Placebo | Pazopanib 800 Milligrams | Total |
|---|---|---|---|
| Mean | 54.1 ± 10.46 | 51.7 ± 9.62 | 52.9 ± 10.09 |
| Sex: Female, Male(Participants) | Placebo | Pazopanib 800 Milligrams | Total |
|---|---|---|---|
| Female | 72 | 73 | 145 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(participants) | Placebo | Pazopanib 800 Milligrams | Total |
|---|---|---|---|
| Asian | 72 | 73 | 145 |
This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
GlaxoSmithKline