Fallopian Tube Cancer, Neoplasms, Ovarian, Ovarian Cancer, Peritoneal Cancer
Conditions
Keywords
Pazopanib, Fallopian tube cancer, Ovarian epithelial cancer, Peritoneal cancer
Brief summary
This study was designed to find out how effective and safe GW786034, is in the treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer that has not responded to standard treatment.
Interventions
DRUGGW786034
800 mg GW786034 administered orally on a daily basis.
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of epithelial ovarian, fallopian tube or primary peritoneal carcinoma. * Has received one prior platinum-based chemotherapy regimen(cisplatin,carboplatin, or oxaliplatin). * Has psychological, familial, sociological or geographical condition that does not permit compliance with the protocol. * Is on a specifically prohibited medication or requires these medications during treatment with GW786034.
Exclusion criteria
* Has had any surgery, chemotherapy, hormonal therapy, biologic, immunotherapy, or radiotherapy with in the last 28 days and has not recovered from such prior therapy. * Poorly controlled hypertension(systolic 140mmHg or higher or Diastolic 90mmHg or higher). * Currently taking warfarin. * Low molecular weight heparin and low-dose warfarin(1mg per day)is permitted.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best Biochemical Response (Cancer Antigen [CA-125]) | Baseline to response (up to 3 years) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Biochemical Response (CA-125) | Baseline to response (up to 3 years) | 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. |
| CA-125 Doubling Time Prior to and During Treatment With Pazopanib | Baseline to doubling of CA-125 (up to 3 years) | 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. |
| Overall Response and Stable Disease (SD) | Baseline to response (up to 3 years) | 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. |
| Median Progression-free Survival (PFS) | 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) | 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. |
| Overall Tumor Response | Baseline to response (up to 3 years) | 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. |
| Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Diastolic Blood Pressure | Baseline to response (up to 3 years) | Summary of shifts in diastolic blood pressure from baseline to the maximum change in the study. mmHg, millimeters of mercury. |
| Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Systolic Blood Pressure | Baseline to response (up to 3 years) | Summary of shifts in systolic blood pressure from baseline to the maximum change in the study. mmHg, millimeters of mercury. |
| Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Heart Rate | Baseline to response (up to 3 years) | Summary of shifts in heart rate from baseline to the maximum change in the study. bpm, beats per minute. |
| Time to Biochemical Response (CA-125) | Baseline to response (up to 3 years) | 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. |
| Mean Change From Baseline to Response in Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase | Baseline to response (up to 3 years) | Change from baseline is calculated as the value at the time of response minus the value at Baseline. |
| Mean Change From Baseline to Response in Amylase and Lipase | Baseline to response (up to 3 years) | Change from baseline is calculated as the value at the time of response minus the value at Baseline. |
| Mean Change From Baseline to Response in Total Bilirubin and Creatinine | Baseline to response (up to 3 years) | Change from baseline is calculated as the value at the time of response minus the value at Baseline. |
| Mean Change From Baseline to Response in Calcium, Glucose, Potassium, Sodium, and Urea | Baseline to response (up to 3 years) | Change from baseline is calculated as the value at the time of response minus the value at Baseline. |
| Mean Change From Baseline to Response in Thyroxine | Baseline to response (up to 3 years) | Change from baseline is calculated as the value at the time of response minus the value at Baseline. |
| Mean Change From Baseline to Response in Thyroid Stimulating Hormone | Baseline to response (up to 3 years) | Change from baseline is calculated as the value at the time of response minus the value at Baseline. |
| Mean Change From Baseline to Response in Hemoglobin and Hematocrit | Baseline to response (up to 3 years) | Change from baseline is calculated as the value at the time of response minus the value at Baseline. |
| Mean Change From Baseline to Response in Lymphocytes, Neutrophils, Platelet Count, and White Blood Count | Baseline to response (up to 3 years) | Change from baseline is calculated as the value at the time of response minus the value at Baseline. |
| Mean Change From Baseline to Response in Albumin | Baseline to response (up to 3 years) | Change from baseline is calculated as the value at the time of response minus the value at Baseline. |
Countries
Australia, Singapore, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pazopanib 800 mg 800 milligrams (mg) pazopanib administered orally once daily | 36 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 7 |
| Overall Study | Death | 1 |
| Overall Study | Disease Progression | 22 |
| Overall Study | Ongoing | 3 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Pazopanib 800 mg |
|---|---|
| Age, Continuous | 59.9 years STANDARD_DEVIATION 11.24 |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 2 participants |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 34 participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 35 / 36 |
| serious Total, serious adverse events | 6 / 36 |
Outcome results
Primary
Best Biochemical Response (Cancer Antigen [CA-125])
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.
Time frame: Baseline to response (up to 3 years)
Population: All participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pazopanib 800 mg | Best Biochemical Response (Cancer Antigen [CA-125]) | 50% Response Normalized | 6 percentage of participants |
| Pazopanib 800 mg | Best Biochemical Response (Cancer Antigen [CA-125]) | 50% Response Non-Normalized | 25 percentage of participants |
| Pazopanib 800 mg | Best Biochemical Response (Cancer Antigen [CA-125]) | Stable Disease | 56 percentage of participants |
| Pazopanib 800 mg | Best Biochemical Response (Cancer Antigen [CA-125]) | Progressive Disease | 3 percentage of participants |
| Pazopanib 800 mg | Best Biochemical Response (Cancer Antigen [CA-125]) | Unconfirmed Progressive Disease | 8 percentage of participants |
| Pazopanib 800 mg | Best Biochemical Response (Cancer Antigen [CA-125]) | Unknown | 3 percentage of participants |
95% CI: [16.3, 48.1]
Secondary
CA-125 Doubling Time Prior to and During Treatment With Pazopanib
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.
Time frame: Baseline to doubling of CA-125 (up to 3 years)
Population: All participants with confirmed CA-125 50% reduction
Secondary
Duration of Biochemical Response (CA-125)
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.
Time frame: Baseline to response (up to 3 years)
Population: All participants with confirmed CA-125 50% reduction
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pazopanib 800 mg | Duration of Biochemical Response (CA-125) | 113 days |
Secondary
Mean Change From Baseline to Response in Albumin
Change from baseline is calculated as the value at the time of response minus the value at Baseline.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pazopanib 800 mg | Mean Change From Baseline to Response in Albumin | -1.5 grams per liter (g/L) | Standard Deviation 8.82 |
Secondary
Mean Change From Baseline to Response in Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase
Change from baseline is calculated as the value at the time of response minus the value at Baseline.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pazopanib 800 mg | 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 |
| Pazopanib 800 mg | 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 |
| Pazopanib 800 mg | 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 |
| Pazopanib 800 mg | 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 29.63 |
Secondary
Mean Change From Baseline to Response in Amylase and Lipase
Change from baseline is calculated as the value at the time of response minus the value at Baseline.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pazopanib 800 mg | Mean Change From Baseline to Response in Amylase and Lipase | Amylase | 7.32 Units per liter (U/L) | Standard Deviation 31.038 |
| Pazopanib 800 mg | Mean Change From Baseline to Response in Amylase and Lipase | Lipase | 7.273 Units per liter (U/L) | Standard Deviation 24.994 |
Secondary
Mean Change From Baseline to Response in Calcium, Glucose, Potassium, Sodium, and Urea
Change from baseline is calculated as the value at the time of response minus the value at Baseline.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pazopanib 800 mg | 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 |
| Pazopanib 800 mg | 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 |
| Pazopanib 800 mg | 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 |
| Pazopanib 800 mg | 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 |
| Pazopanib 800 mg | 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 1.341 |
Secondary
Mean Change From Baseline to Response in Hemoglobin and Hematocrit
Change from baseline is calculated as the value at the time of response minus the value at Baseline.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pazopanib 800 mg | Mean Change From Baseline to Response in Hemoglobin and Hematocrit | Hemoglobin | -0.53 g/L | Standard Deviation 13.952 |
| Pazopanib 800 mg | Mean Change From Baseline to Response in Hemoglobin and Hematocrit | Hematocrit | -0.00 g/L | Standard Deviation 0.048 |
Secondary
Mean Change From Baseline to Response in Lymphocytes, Neutrophils, Platelet Count, and White Blood Count
Change from baseline is calculated as the value at the time of response minus the value at Baseline.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pazopanib 800 mg | 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 |
| Pazopanib 800 mg | 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 |
| Pazopanib 800 mg | 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 |
| Pazopanib 800 mg | 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 |
Secondary
Mean Change From Baseline to Response in Thyroid Stimulating Hormone
Change from baseline is calculated as the value at the time of response minus the value at Baseline.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pazopanib 800 mg | Mean Change From Baseline to Response in Thyroid Stimulating Hormone | 0.87 milliunits per liter (MU/L) | Standard Deviation 1.693 |
Secondary
Mean Change From Baseline to Response in Thyroxine
Change from baseline is calculated as the value at the time of response minus the value at Baseline.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pazopanib 800 mg | Mean Change From Baseline to Response in Thyroxine | 0.003 nanomoles per liter (nmol/l) | Standard Deviation 0.0018 |
Secondary
Mean Change From Baseline to Response in Total Bilirubin and Creatinine
Change from baseline is calculated as the value at the time of response minus the value at Baseline.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pazopanib 800 mg | Mean Change From Baseline to Response in Total Bilirubin and Creatinine | Total bilirubin | 0.715 micromoles per liter (umol/l) | Standard Deviation 2.7039 |
| Pazopanib 800 mg | Mean Change From Baseline to Response in Total Bilirubin and Creatinine | Creatinine | 1.37 micromoles per liter (umol/l) | Standard Deviation 8.846 |
Secondary
Median Progression-free Survival (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.
Time frame: 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pazopanib 800 mg | Median Progression-free Survival (PFS) | 168 days |
| Pazopanib 800 mg Without Measurable Disease | Median Progression-free Survival (PFS) | 57 days |
| Pazopanib 800 mg All | Median Progression-free Survival (PFS) | 84 days |
Secondary
Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Diastolic Blood Pressure
Summary of shifts in diastolic blood pressure from baseline to the maximum change in the study. mmHg, millimeters of mercury.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pazopanib 800 mg | 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 |
| Pazopanib 800 mg | 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 |
| Pazopanib 800 mg | 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 |
| Pazopanib 800 mg | 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 |
| Pazopanib 800 mg | 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 |
| Pazopanib 800 mg | 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 |
| Pazopanib 800 mg | 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 |
| Pazopanib 800 mg | 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
Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Heart Rate
Summary of shifts in heart rate from baseline to the maximum change in the study. bpm, beats per minute.
Time frame: Baseline to response (up to 3 years)
Population: All participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pazopanib 800 mg | 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 |
| Pazopanib 800 mg | 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 |
| Pazopanib 800 mg | 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 |
| Pazopanib 800 mg | 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 |
| Pazopanib 800 mg | 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 |
| Pazopanib 800 mg | 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 |
| Pazopanib 800 mg | 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 |
| Pazopanib 800 mg | 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
Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Systolic Blood Pressure
Summary of shifts in systolic blood pressure from baseline to the maximum change in the study. mmHg, millimeters of mercury.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pazopanib 800 mg | 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 |
| Pazopanib 800 mg | 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 |
| Pazopanib 800 mg | 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 |
| Pazopanib 800 mg | 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 |
| Pazopanib 800 mg | 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 |
| Pazopanib 800 mg | 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 |
| Pazopanib 800 mg | 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 |
| Pazopanib 800 mg | 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 |
| Pazopanib 800 mg | 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 |
| Pazopanib 800 mg | 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 |
| Pazopanib 800 mg | 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
Overall Response and Stable Disease (SD)
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.
Time frame: Baseline to response (up to 3 years)
Population: All participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pazopanib 800 mg | Overall Response and Stable Disease (SD) | Progressive Disease | 64.7 percentage of participants |
| Pazopanib 800 mg | Overall Response and Stable Disease (SD) | Stable Disease | 17.6 percentage of participants |
| Pazopanib 800 mg | Overall Response and Stable Disease (SD) | Complete Reponse | 0 percentage of participants |
| Pazopanib 800 mg | Overall Response and Stable Disease (SD) | Partial Response | 17.6 percentage of participants |
| Pazopanib 800 mg | Overall Response and Stable Disease (SD) | Unknown | 0 percentage of participants |
| Pazopanib 800 mg Without Measurable Disease | Overall Response and Stable Disease (SD) | Stable Disease | 26.3 percentage of participants |
| Pazopanib 800 mg Without Measurable Disease | Overall Response and Stable Disease (SD) | Complete Reponse | 5.3 percentage of participants |
| Pazopanib 800 mg Without Measurable Disease | Overall Response and Stable Disease (SD) | Partial Response | 15.8 percentage of participants |
| Pazopanib 800 mg Without Measurable Disease | Overall Response and Stable Disease (SD) | Progressive Disease | 47.4 percentage of participants |
| Pazopanib 800 mg Without Measurable Disease | Overall Response and Stable Disease (SD) | Unknown | 5.3 percentage of participants |
| Pazopanib 800 mg All | Overall Response and Stable Disease (SD) | Unknown | 2.8 percentage of participants |
| Pazopanib 800 mg All | Overall Response and Stable Disease (SD) | Progressive Disease | 55.6 percentage of participants |
| Pazopanib 800 mg All | Overall Response and Stable Disease (SD) | Complete Reponse | 2.8 percentage of participants |
| Pazopanib 800 mg All | Overall Response and Stable Disease (SD) | Stable Disease | 22.2 percentage of participants |
| Pazopanib 800 mg All | Overall Response and Stable Disease (SD) | Partial Response | 16.7 percentage of participants |
95% CI: [3.8, 43.4]
95% CI: [6.1, 45.6]
95% CI: [8.2, 36]
Secondary
Overall Tumor Response
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.
Time frame: Baseline to response (up to 3 years)
Population: All participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pazopanib 800 mg | Overall Tumor Response | Complete Response | 0 participants |
| Pazopanib 800 mg | Overall Tumor Response | Partial Response | 0 participants |
| Pazopanib 800 mg | Overall Tumor Response | Stable Disease | 5 participants |
| Pazopanib 800 mg | Overall Tumor Response | Progressive Disease | 10 participants |
| Pazopanib 800 mg | Overall Tumor Response | Unknown | 2 participants |
Secondary
Time to Biochemical Response (CA-125)
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.
Time frame: Baseline to response (up to 3 years)
Population: All participants with confirmed CA-125 50% reduction
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pazopanib 800 mg | Time to Biochemical Response (CA-125) | 29 days |