Trial Outcomes & Findings for A Phase II, Open-Label Study Evaluating the Effect Of GW786034 In Subjects With Ovarian Cancer (NCT NCT00281632)
NCT ID: NCT00281632
Last Updated: 2018-09-17
Results Overview
Defined using modified Gynecologic Cancer Intergroup (GCIG) criteria: 50% response=≥50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments) then confirmed after 21 days. 50% CA-125 response was normalized (CA-125 \>21U/mL) or non-normalized (CA-125≤1U/mL). Progressive disease (PD) =CA-125 increase ≥100% from nadir (nadir \>21U/mL) or ≥42U/mL (nadir ≤21U/mL); nadir was lowest CA-125. PD was confirmed after 21 days; otherwise=unconfirmed PD. Stable disease=scenarios that do not meet 50% response or PD. CA-125 response rate was defined as % of participants with 50% response.
COMPLETED
PHASE2
35 participants
Baseline to response (up to 3 years)
2018-09-17
Participant Flow
Participant milestones
| Measure |
Pazopanib 800 mg
800 milligrams (mg) pazopanib administered orally once daily
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
36
|
Reasons for withdrawal
| Measure |
Pazopanib 800 mg
800 milligrams (mg) pazopanib administered orally once daily
|
|---|---|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Disease Progression
|
22
|
|
Overall Study
Death
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Ongoing
|
3
|
Baseline Characteristics
A Phase II, Open-Label Study Evaluating the Effect Of GW786034 In Subjects With Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Pazopanib 800 mg
n=36 Participants
800 milligrams (mg) pazopanib administered orally once daily
|
|---|---|
|
Age, Continuous
|
59.9 years
STANDARD_DEVIATION 11.24 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
34 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to response (up to 3 years)Population: All participants
Defined using modified Gynecologic Cancer Intergroup (GCIG) criteria: 50% response=≥50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments) then confirmed after 21 days. 50% CA-125 response was normalized (CA-125 \>21U/mL) or non-normalized (CA-125≤1U/mL). Progressive disease (PD) =CA-125 increase ≥100% from nadir (nadir \>21U/mL) or ≥42U/mL (nadir ≤21U/mL); nadir was lowest CA-125. PD was confirmed after 21 days; otherwise=unconfirmed PD. Stable disease=scenarios that do not meet 50% response or PD. CA-125 response rate was defined as % of participants with 50% response.
Outcome measures
| Measure |
Pazopanib 800 mg
n=36 Participants
800 milligrams (mg) pazopanib administered orally once daily
|
Pazopanib 800 mg Without Measurable Disease
Participants without measureable disease at baseline who were administered 800 milligrams (mg) pazopanib administered orally once daily.
|
Pazopanib 800 mg All
All participants administered 800 milligrams (mg) pazopanib administered orally once daily
|
|---|---|---|---|
|
Best Biochemical Response (Cancer Antigen [CA-125])
50% Response Normalized
|
6 percentage of participants
|
—
|
—
|
|
Best Biochemical Response (Cancer Antigen [CA-125])
50% Response Non-Normalized
|
25 percentage of participants
|
—
|
—
|
|
Best Biochemical Response (Cancer Antigen [CA-125])
Stable Disease
|
56 percentage of participants
|
—
|
—
|
|
Best Biochemical Response (Cancer Antigen [CA-125])
Progressive Disease
|
3 percentage of participants
|
—
|
—
|
|
Best Biochemical Response (Cancer Antigen [CA-125])
Unconfirmed Progressive Disease
|
8 percentage of participants
|
—
|
—
|
|
Best Biochemical Response (Cancer Antigen [CA-125])
Unknown
|
3 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to response (up to 3 years)Population: All participants with confirmed CA-125 50% reduction
Time to biochemical response was calculated as the date pazopanib was first dosed to the date CA-125 was first reduced by 50% or greater. The reduction in CA-125 of 50% or greater was to be confirmed by a repeat measurement (no earlier than 21 days after initial evaluation documenting decrement). This was calculated for all participants with confirmed CA-125 50% reduction.
Outcome measures
| Measure |
Pazopanib 800 mg
n=11 Participants
800 milligrams (mg) pazopanib administered orally once daily
|
Pazopanib 800 mg Without Measurable Disease
Participants without measureable disease at baseline who were administered 800 milligrams (mg) pazopanib administered orally once daily.
|
Pazopanib 800 mg All
All participants administered 800 milligrams (mg) pazopanib administered orally once daily
|
|---|---|---|---|
|
Time to Biochemical Response (CA-125)
|
29 days
Interval 27.0 to 57.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to response (up to 3 years)Population: All participants with confirmed CA-125 50% reduction
Calculated as the date of confirmed first 50% or greater reduction in CA-125 to date of documented progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest. This was calculated for all participants with confirmed CA-125 50% reduction.
Outcome measures
| Measure |
Pazopanib 800 mg
n=11 Participants
800 milligrams (mg) pazopanib administered orally once daily
|
Pazopanib 800 mg Without Measurable Disease
Participants without measureable disease at baseline who were administered 800 milligrams (mg) pazopanib administered orally once daily.
|
Pazopanib 800 mg All
All participants administered 800 milligrams (mg) pazopanib administered orally once daily
|
|---|---|---|---|
|
Duration of Biochemical Response (CA-125)
|
113 days
Interval 58.0 to 190.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to doubling of CA-125 (up to 3 years)Population: All participants with confirmed CA-125 50% reduction
CA-125 doubling time is defined as the time for CA-125 to double from baseline value. This measure was not reported, as no participants had a post-baseline CA-125 that was double the baseline value. Therefore, the data did not warrant a report.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to response (up to 3 years)Population: All participants
Overall response and stable disease (SD) are based on biochemical, radiographic, and clinical assessments according to the modified criteria of Gynecologic Cancer Intergroup (GCIG) (see primary outcome). Response is presented as the percentage of participants with the given response.
Outcome measures
| Measure |
Pazopanib 800 mg
n=17 Participants
800 milligrams (mg) pazopanib administered orally once daily
|
Pazopanib 800 mg Without Measurable Disease
n=19 Participants
Participants without measureable disease at baseline who were administered 800 milligrams (mg) pazopanib administered orally once daily.
|
Pazopanib 800 mg All
n=36 Participants
All participants administered 800 milligrams (mg) pazopanib administered orally once daily
|
|---|---|---|---|
|
Overall Response and Stable Disease (SD)
Complete Reponse
|
0 percentage of participants
|
5.3 percentage of participants
|
2.8 percentage of participants
|
|
Overall Response and Stable Disease (SD)
Partial Response
|
17.6 percentage of participants
|
15.8 percentage of participants
|
16.7 percentage of participants
|
|
Overall Response and Stable Disease (SD)
Stable Disease
|
17.6 percentage of participants
|
26.3 percentage of participants
|
22.2 percentage of participants
|
|
Overall Response and Stable Disease (SD)
Progressive Disease
|
64.7 percentage of participants
|
47.4 percentage of participants
|
55.6 percentage of participants
|
|
Overall Response and Stable Disease (SD)
Unknown
|
0 percentage of participants
|
5.3 percentage of participants
|
2.8 percentage of participants
|
SECONDARY outcome
Timeframe: Date of the first dose of study drug to the date of documented and confirmed progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest, or to date of death due to any causes (up to 2 years)Population: All participants with PFS
Progression-free survival analysis was performed on all participants and then stratified by CA-125 response status (having confirmed 50% reduction or not). PFS was defined as the time from the date of the first dose of study drug to the date of documented and confirmed progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest, or to date of death due to any causes.
Outcome measures
| Measure |
Pazopanib 800 mg
n=10 Participants
800 milligrams (mg) pazopanib administered orally once daily
|
Pazopanib 800 mg Without Measurable Disease
n=20 Participants
Participants without measureable disease at baseline who were administered 800 milligrams (mg) pazopanib administered orally once daily.
|
Pazopanib 800 mg All
n=30 Participants
All participants administered 800 milligrams (mg) pazopanib administered orally once daily
|
|---|---|---|---|
|
Median Progression-free Survival (PFS)
|
168 days
Interval 84.0 to 217.0
|
57 days
Interval 51.0 to 85.0
|
84 days
Interval 57.0 to 141.0
|
SECONDARY outcome
Timeframe: Baseline to response (up to 3 years)Population: All participants
Overall tumor response following daily administration of pazopanib was defined using radiographic assessments based on Response Evaluation Criteria for Solid Tumors (RECIST) criteria for subjects with measurable disease at baseline.
Outcome measures
| Measure |
Pazopanib 800 mg
n=17 Participants
800 milligrams (mg) pazopanib administered orally once daily
|
Pazopanib 800 mg Without Measurable Disease
Participants without measureable disease at baseline who were administered 800 milligrams (mg) pazopanib administered orally once daily.
|
Pazopanib 800 mg All
All participants administered 800 milligrams (mg) pazopanib administered orally once daily
|
|---|---|---|---|
|
Overall Tumor Response
Complete Response
|
0 participants
|
—
|
—
|
|
Overall Tumor Response
Partial Response
|
0 participants
|
—
|
—
|
|
Overall Tumor Response
Stable Disease
|
5 participants
|
—
|
—
|
|
Overall Tumor Response
Progressive Disease
|
10 participants
|
—
|
—
|
|
Overall Tumor Response
Unknown
|
2 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to response (up to 3 years)Population: All participants. Data are presented for only those participants who provided measurements at baseline and maximum shift post-baseline.
Summary of shifts in diastolic blood pressure from baseline to the maximum change in the study. mmHg, millimeters of mercury.
Outcome measures
| Measure |
Pazopanib 800 mg
n=36 Participants
800 milligrams (mg) pazopanib administered orally once daily
|
Pazopanib 800 mg Without Measurable Disease
Participants without measureable disease at baseline who were administered 800 milligrams (mg) pazopanib administered orally once daily.
|
Pazopanib 800 mg All
All participants administered 800 milligrams (mg) pazopanib administered orally once daily
|
|---|---|---|---|
|
Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Diastolic Blood Pressure
BL, 50-89 mmHg; shift to post-BL, <50 mmHg
|
0 participants
|
—
|
—
|
|
Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Diastolic Blood Pressure
BL, 50-89 mmHg; shift to post-BL, 50-89 mmHg
|
16 participants
|
—
|
—
|
|
Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Diastolic Blood Pressure
BL, 50-89 mmHg; shift to post-BL, 90-109 mmHg
|
16 participants
|
—
|
—
|
|
Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Diastolic Blood Pressure
BL, 50-89 mmHg; shift to post-BL, >=109 mmHg
|
0 participants
|
—
|
—
|
|
Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Diastolic Blood Pressure
BL, 90-109 mmHg; shift to post-BL, <50 mmHg
|
0 participants
|
—
|
—
|
|
Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Diastolic Blood Pressure
BL, 90-109 mmHg; shift to post-BL, 50-89 mmHg
|
3 participants
|
—
|
—
|
|
Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Diastolic Blood Pressure
BL, 90-109 mmHg; shift to post-BL, 90-109 mmHg
|
1 participants
|
—
|
—
|
|
Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Diastolic Blood Pressure
BL, 90-109 mmHg; shift to post-BL, >=109 mmHg
|
0 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to response (up to 3 years)Population: All participants. Data are presented for only those participants who provided measurements at baseline and maximum shift post-baseline.
Summary of shifts in systolic blood pressure from baseline to the maximum change in the study. mmHg, millimeters of mercury.
Outcome measures
| Measure |
Pazopanib 800 mg
n=36 Participants
800 milligrams (mg) pazopanib administered orally once daily
|
Pazopanib 800 mg Without Measurable Disease
Participants without measureable disease at baseline who were administered 800 milligrams (mg) pazopanib administered orally once daily.
|
Pazopanib 800 mg All
All participants administered 800 milligrams (mg) pazopanib administered orally once daily
|
|---|---|---|---|
|
Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Systolic Blood Pressure
BL, 90-139 mmHg; shift to post-BL, <90 mmHg
|
0 participants
|
—
|
—
|
|
Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Systolic Blood Pressure
BL, 90-139 mmHg; shift to post-BL, 90-139 mmHg
|
13 participants
|
—
|
—
|
|
Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Systolic Blood Pressure
BL, 90-139 mmHg; shift to post-BL, 140-169 mmHg
|
16 participants
|
—
|
—
|
|
Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Systolic Blood Pressure
BL, 90-139 mmHg; shift to post-BL, >=170 mmHg
|
2 participants
|
—
|
—
|
|
Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Systolic Blood Pressure
BL, 140-169 mmHg; shift to post-BL, <90 mmHg
|
0 participants
|
—
|
—
|
|
Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Systolic Blood Pressure
BL, 140-169 mmHg; shift to post-BL, 90-139 mmHg
|
0 participants
|
—
|
—
|
|
Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Systolic Blood Pressure
BL, 140-169 mmHg; shift to post-BL, 140-169 mmHg
|
5 participants
|
—
|
—
|
|
Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Systolic Blood Pressure
BL, 140-169 mmHg; shift to post-BL, >=170 mmHg
|
0 participants
|
—
|
—
|
|
Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Systolic Blood Pressure
BL, >=170 mmHg; shift to post-BL, 90-139 mmHg
|
0 participants
|
—
|
—
|
|
Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Systolic Blood Pressure
BL, >=170 mmHg; shift to post-BL, 140-169 mmHg
|
0 participants
|
—
|
—
|
|
Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Systolic Blood Pressure
BL, >=170 mmHg; shift to post-BL, >=170 mmHg
|
0 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to response (up to 3 years)Population: All participants
Summary of shifts in heart rate from baseline to the maximum change in the study. bpm, beats per minute.
Outcome measures
| Measure |
Pazopanib 800 mg
n=36 Participants
800 milligrams (mg) pazopanib administered orally once daily
|
Pazopanib 800 mg Without Measurable Disease
Participants without measureable disease at baseline who were administered 800 milligrams (mg) pazopanib administered orally once daily.
|
Pazopanib 800 mg All
All participants administered 800 milligrams (mg) pazopanib administered orally once daily
|
|---|---|---|---|
|
Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Heart Rate
BL, 44-100 bpm; shift to post-BL, <44 bpm
|
0 participants
|
—
|
—
|
|
Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Heart Rate
BL, 44-100 bpm; shift to post-BL, 44-100 bpm
|
32 participants
|
—
|
—
|
|
Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Heart Rate
BL, 44-100 bpm; shift to post-BL, 101-120 bpm
|
3 participants
|
—
|
—
|
|
Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Heart Rate
BL, 44-100 bpm; shift to post-BL, >120 bpm
|
0 participants
|
—
|
—
|
|
Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Heart Rate
BL, 101-120 bpm; shift to post-BL, <44 bpm
|
0 participants
|
—
|
—
|
|
Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Heart Rate
BL, 101-120 bpm; shift to post-BL, 44-100 bpm
|
1 participants
|
—
|
—
|
|
Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Heart Rate
BL, 101-120 bpm; shift to post-BL, 101-120 bpm
|
0 participants
|
—
|
—
|
|
Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Heart Rate
BL, 101-120 bpm; shift to post-BL, >120 bpm
|
0 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to response (up to 3 years)Population: All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response.
Change from baseline is calculated as the value at the time of response minus the value at Baseline.
Outcome measures
| Measure |
Pazopanib 800 mg
n=29 Participants
800 milligrams (mg) pazopanib administered orally once daily
|
Pazopanib 800 mg Without Measurable Disease
Participants without measureable disease at baseline who were administered 800 milligrams (mg) pazopanib administered orally once daily.
|
Pazopanib 800 mg All
All participants administered 800 milligrams (mg) pazopanib administered orally once daily
|
|---|---|---|---|
|
Mean Change From Baseline to Response in Albumin
|
-1.5 grams per liter (g/L)
Standard Deviation 8.82
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to response (up to 3 years)Population: All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response.
Change from baseline is calculated as the value at the time of response minus the value at Baseline.
Outcome measures
| Measure |
Pazopanib 800 mg
n=29 Participants
800 milligrams (mg) pazopanib administered orally once daily
|
Pazopanib 800 mg Without Measurable Disease
Participants without measureable disease at baseline who were administered 800 milligrams (mg) pazopanib administered orally once daily.
|
Pazopanib 800 mg All
All participants administered 800 milligrams (mg) pazopanib administered orally once daily
|
|---|---|---|---|
|
Mean Change From Baseline to Response in Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase
Alkaline phosphatase, n=29
|
7.3 International Units per liter (IU/L)
Standard Deviation 27.76
|
—
|
—
|
|
Mean Change From Baseline to Response in Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase
Alanine aminotransferase, n=29
|
13.0 International Units per liter (IU/L)
Standard Deviation 23.25
|
—
|
—
|
|
Mean Change From Baseline to Response in Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase
Aspartate aminotransferase, n=28
|
7.1 International Units per liter (IU/L)
Standard Deviation 12.65
|
—
|
—
|
|
Mean Change From Baseline to Response in Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase
Lactate dehydrogenase, n=21
|
4.62 International Units per liter (IU/L)
Standard Deviation 29.630
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to response (up to 3 years)Population: All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response.
Change from baseline is calculated as the value at the time of response minus the value at Baseline.
Outcome measures
| Measure |
Pazopanib 800 mg
n=22 Participants
800 milligrams (mg) pazopanib administered orally once daily
|
Pazopanib 800 mg Without Measurable Disease
Participants without measureable disease at baseline who were administered 800 milligrams (mg) pazopanib administered orally once daily.
|
Pazopanib 800 mg All
All participants administered 800 milligrams (mg) pazopanib administered orally once daily
|
|---|---|---|---|
|
Mean Change From Baseline to Response in Amylase and Lipase
Amylase
|
7.32 Units per liter (U/L)
Standard Deviation 31.038
|
—
|
—
|
|
Mean Change From Baseline to Response in Amylase and Lipase
Lipase
|
7.273 Units per liter (U/L)
Standard Deviation 24.994
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to response (up to 3 years)Population: All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response.
Change from baseline is calculated as the value at the time of response minus the value at Baseline.
Outcome measures
| Measure |
Pazopanib 800 mg
n=29 Participants
800 milligrams (mg) pazopanib administered orally once daily
|
Pazopanib 800 mg Without Measurable Disease
Participants without measureable disease at baseline who were administered 800 milligrams (mg) pazopanib administered orally once daily.
|
Pazopanib 800 mg All
All participants administered 800 milligrams (mg) pazopanib administered orally once daily
|
|---|---|---|---|
|
Mean Change From Baseline to Response in Total Bilirubin and Creatinine
Total bilirubin
|
0.715 micromoles per liter (umol/l)
Standard Deviation 2.7039
|
—
|
—
|
|
Mean Change From Baseline to Response in Total Bilirubin and Creatinine
Creatinine
|
1.37 micromoles per liter (umol/l)
Standard Deviation 8.846
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to response (up to 3 years)Population: All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response.
Change from baseline is calculated as the value at the time of response minus the value at Baseline.
Outcome measures
| Measure |
Pazopanib 800 mg
n=29 Participants
800 milligrams (mg) pazopanib administered orally once daily
|
Pazopanib 800 mg Without Measurable Disease
Participants without measureable disease at baseline who were administered 800 milligrams (mg) pazopanib administered orally once daily.
|
Pazopanib 800 mg All
All participants administered 800 milligrams (mg) pazopanib administered orally once daily
|
|---|---|---|---|
|
Mean Change From Baseline to Response in Calcium, Glucose, Potassium, Sodium, and Urea
Glucose, n=28
|
0.302 millimoles per liter (mmol/l)
Standard Deviation 1.7285
|
—
|
—
|
|
Mean Change From Baseline to Response in Calcium, Glucose, Potassium, Sodium, and Urea
Potassium, n=28
|
-0.02 millimoles per liter (mmol/l)
Standard Deviation 0.553
|
—
|
—
|
|
Mean Change From Baseline to Response in Calcium, Glucose, Potassium, Sodium, and Urea
Sodium, n=29
|
0.1 millimoles per liter (mmol/l)
Standard Deviation 2.85
|
—
|
—
|
|
Mean Change From Baseline to Response in Calcium, Glucose, Potassium, Sodium, and Urea
Urea, n=29
|
-0.227 millimoles per liter (mmol/l)
Standard Deviation 1.3410
|
—
|
—
|
|
Mean Change From Baseline to Response in Calcium, Glucose, Potassium, Sodium, and Urea
Calcium, n=29
|
-0.038 millimoles per liter (mmol/l)
Standard Deviation 0.1034
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to response (up to 3 years)Population: All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response.
Change from baseline is calculated as the value at the time of response minus the value at Baseline.
Outcome measures
| Measure |
Pazopanib 800 mg
n=2 Participants
800 milligrams (mg) pazopanib administered orally once daily
|
Pazopanib 800 mg Without Measurable Disease
Participants without measureable disease at baseline who were administered 800 milligrams (mg) pazopanib administered orally once daily.
|
Pazopanib 800 mg All
All participants administered 800 milligrams (mg) pazopanib administered orally once daily
|
|---|---|---|---|
|
Mean Change From Baseline to Response in Thyroxine
|
0.003 nanomoles per liter (nmol/l)
Standard Deviation 0.0018
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to response (up to 3 years)Population: All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response.
Change from baseline is calculated as the value at the time of response minus the value at Baseline.
Outcome measures
| Measure |
Pazopanib 800 mg
n=24 Participants
800 milligrams (mg) pazopanib administered orally once daily
|
Pazopanib 800 mg Without Measurable Disease
Participants without measureable disease at baseline who were administered 800 milligrams (mg) pazopanib administered orally once daily.
|
Pazopanib 800 mg All
All participants administered 800 milligrams (mg) pazopanib administered orally once daily
|
|---|---|---|---|
|
Mean Change From Baseline to Response in Thyroid Stimulating Hormone
|
0.87 milliunits per liter (MU/L)
Standard Deviation 1.693
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to response (up to 3 years)Population: All participants. Data are presented for only those participants who provided hematology measurements at both baseline and the time of response.
Change from baseline is calculated as the value at the time of response minus the value at Baseline.
Outcome measures
| Measure |
Pazopanib 800 mg
n=30 Participants
800 milligrams (mg) pazopanib administered orally once daily
|
Pazopanib 800 mg Without Measurable Disease
Participants without measureable disease at baseline who were administered 800 milligrams (mg) pazopanib administered orally once daily.
|
Pazopanib 800 mg All
All participants administered 800 milligrams (mg) pazopanib administered orally once daily
|
|---|---|---|---|
|
Mean Change From Baseline to Response in Hemoglobin and Hematocrit
Hemoglobin
|
-0.53 g/L
Standard Deviation 13.952
|
—
|
—
|
|
Mean Change From Baseline to Response in Hemoglobin and Hematocrit
Hematocrit
|
-0.00 g/L
Standard Deviation 0.048
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to response (up to 3 years)Population: All participants. Data are presented for only those participants who provided hematology measurements at both baseline and the time of response.
Change from baseline is calculated as the value at the time of response minus the value at Baseline.
Outcome measures
| Measure |
Pazopanib 800 mg
n=30 Participants
800 milligrams (mg) pazopanib administered orally once daily
|
Pazopanib 800 mg Without Measurable Disease
Participants without measureable disease at baseline who were administered 800 milligrams (mg) pazopanib administered orally once daily.
|
Pazopanib 800 mg All
All participants administered 800 milligrams (mg) pazopanib administered orally once daily
|
|---|---|---|---|
|
Mean Change From Baseline to Response in Lymphocytes, Neutrophils, Platelet Count, and White Blood Count
Lymphocytes
|
0.32 giga (10^9) per liter (GI/L)
Standard Deviation 2.191
|
—
|
—
|
|
Mean Change From Baseline to Response in Lymphocytes, Neutrophils, Platelet Count, and White Blood Count
Neutrophils
|
-0.12 giga (10^9) per liter (GI/L)
Standard Deviation 2.276
|
—
|
—
|
|
Mean Change From Baseline to Response in Lymphocytes, Neutrophils, Platelet Count, and White Blood Count
Platelet count
|
-9.93 giga (10^9) per liter (GI/L)
Standard Deviation 75.487
|
—
|
—
|
|
Mean Change From Baseline to Response in Lymphocytes, Neutrophils, Platelet Count, and White Blood Count
White blood cell count
|
-0.28 giga (10^9) per liter (GI/L)
Standard Deviation 2.373
|
—
|
—
|
Adverse Events
Pazopanib 800 mg
Serious adverse events
| Measure |
Pazopanib 800 mg
n=36 participants at risk
800 milligrams (mg) pazopanib administered orally once daily
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
5.6%
2/36
|
|
Gastrointestinal disorders
Intestinal obstruction
|
5.6%
2/36
|
|
Gastrointestinal disorders
Abdominal pain
|
2.8%
1/36
|
|
Investigations
Hepatic enzyme increased
|
2.8%
1/36
|
|
Metabolism and nutrition disorders
Dehydration
|
2.8%
1/36
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer situ
|
2.8%
1/36
|
|
Renal and urinary disorders
Urinary retention
|
2.8%
1/36
|
|
Vascular disorders
Hypertension
|
2.8%
1/36
|
Other adverse events
| Measure |
Pazopanib 800 mg
n=36 participants at risk
800 milligrams (mg) pazopanib administered orally once daily
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
47.2%
17/36
|
|
Gastrointestinal disorders
Nausea
|
47.2%
17/36
|
|
Gastrointestinal disorders
Abdominal pain
|
30.6%
11/36
|
|
Gastrointestinal disorders
Vomiting
|
22.2%
8/36
|
|
Gastrointestinal disorders
Constipation
|
19.4%
7/36
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.7%
6/36
|
|
Gastrointestinal disorders
Dyspepsia
|
13.9%
5/36
|
|
Gastrointestinal disorders
Abdominal distensions
|
11.1%
4/36
|
|
Gastrointestinal disorders
Ascites
|
11.1%
4/36
|
|
Gastrointestinal disorders
Abdominal pain lower
|
5.6%
2/36
|
|
Gastrointestinal disorders
Mouth ulceration
|
5.6%
2/36
|
|
General disorders
Fatigue
|
47.2%
17/36
|
|
General disorders
Edema peripheral
|
8.3%
3/36
|
|
General disorders
Malaise
|
5.6%
2/36
|
|
General disorders
Mucosal inflammation
|
5.6%
2/36
|
|
General disorders
Pain
|
5.6%
2/36
|
|
General disorders
Pyrexia
|
5.6%
2/36
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
6/36
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
6/36
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.9%
5/36
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
13.9%
5/36
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
8.3%
3/36
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.6%
2/36
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.6%
2/36
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.3%
3/36
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.3%
3/36
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.3%
3/36
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
2/36
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.6%
2/36
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
9/36
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
9/36
|
|
Investigations
Gamma-glutamyltransferase increased
|
16.7%
6/36
|
|
Investigations
Blood alkaline phosphastase
|
5.6%
2/36
|
|
Investigations
Blood lactate dehydrogenase increased
|
5.6%
2/36
|
|
Nervous system disorders
Headache
|
16.7%
6/36
|
|
Nervous system disorders
Dizziness
|
8.3%
3/36
|
|
Nervous system disorders
Dysgeusia
|
5.6%
2/36
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.6%
2/36
|
|
Metabolism and nutrition disorders
Anorexia
|
22.2%
8/36
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.3%
3/36
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
2/36
|
|
Skin and subcutaneous tissue disorders
Hair color changes
|
22.2%
8/36
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
4/36
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.6%
2/36
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.6%
2/36
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
5.6%
2/36
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
5.6%
2/36
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
5.6%
2/36
|
|
Vascular disorders
Hypertension
|
30.6%
11/36
|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
3/36
|
|
Infections and infestations
Urinary tract infection
|
5.6%
2/36
|
|
Blood and lymphatic system disorders
Anemia
|
5.6%
2/36
|
|
Blood and lymphatic system disorders
Lymph node pain
|
5.6%
2/36
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.6%
2/36
|
|
Psychiatric disorders
Insomnia
|
11.1%
4/36
|
|
Ear and labyrinth disorders
Tinnitus
|
5.6%
2/36
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER