Back to resultsA Phase II, Open-Label Study Evaluating the Effect Of GW786034 In Subjects With Ovarian Cancer
Primary Purpose
Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GW786034
Sponsored by
About this trial
This is an interventional treatment trial for Peritoneal Cancer focused on measuring Pazopanib, Fallopian tube cancer, Ovarian epithelial cancer, Peritoneal cancer
Eligibility Criteria
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.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pazopanib
Arm Description
800 mg GW786034 administered orally on a daily basis.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00281632
Brief Title
A Phase II, Open-Label Study Evaluating the Effect Of GW786034 In Subjects With Ovarian Cancer
Official Title
This Study is a Non-randomized, Open-label, Multi-center Phase II Study of GW786034 to Evaluate the Administration of Oral GW786034 in Subjects With Ovarian Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer
Keywords
Pazopanib, Fallopian tube cancer, Ovarian epithelial cancer, Peritoneal cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pazopanib
Arm Type
Experimental
Arm Description
800 mg GW786034 administered orally on a daily basis.
Intervention Type
Drug
Intervention Name(s)
GW786034
Intervention Description
800 mg GW786034 administered orally on a daily basis.
Primary Outcome Measure Information:
Title
Best Biochemical Response (Cancer Antigen [CA-125])
Description
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)
Secondary Outcome Measure Information:
Title
Time to Biochemical Response (CA-125)
Description
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)
Title
Duration of Biochemical Response (CA-125)
Description
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)
Title
CA-125 Doubling Time Prior to and During Treatment With Pazopanib
Description
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)
Title
Overall Response and Stable Disease (SD)
Description
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)
Title
Median Progression-free Survival (PFS)
Description
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)
Title
Overall Tumor Response
Description
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)
Title
Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Diastolic Blood Pressure
Description
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)
Title
Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Systolic Blood Pressure
Description
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)
Title
Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Heart Rate
Description
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)
Title
Mean Change From Baseline to Response in Albumin
Description
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)
Title
Mean Change From Baseline to Response in Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase
Description
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)
Title
Mean Change From Baseline to Response in Amylase and Lipase
Description
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)
Title
Mean Change From Baseline to Response in Total Bilirubin and Creatinine
Description
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)
Title
Mean Change From Baseline to Response in Calcium, Glucose, Potassium, Sodium, and Urea
Description
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)
Title
Mean Change From Baseline to Response in Thyroxine
Description
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)
Title
Mean Change From Baseline to Response in Thyroid Stimulating Hormone
Description
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)
Title
Mean Change From Baseline to Response in Hemoglobin and Hematocrit
Description
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)
Title
Mean Change From Baseline to Response in Lymphocytes, Neutrophils, Platelet Count, and White Blood Count
Description
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)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, MD
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
GSK Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
GSK Investigational Site
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
GSK Investigational Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
GSK Investigational Site
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
GSK Investigational Site
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
GSK Investigational Site
City
Melbourne
ZIP/Postal Code
3084
Country
Australia
Facility Name
GSK Investigational Site
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
GSK Investigational Site
City
Singapore
ZIP/Postal Code
229899
Country
Singapore
12. IPD Sharing Statement
Citations:
PubMed Identifier
20584542
Citation
Friedlander M, Hancock KC, Rischin D, Messing MJ, Stringer CA, Matthys GM, Ma B, Hodge JP, Lager JJ. A Phase II, open-label study evaluating pazopanib in patients with recurrent ovarian cancer. Gynecol Oncol. 2010 Oct;119(1):32-7. doi: 10.1016/j.ygyno.2010.05.033. Epub 2010 Jun 27.
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A Phase II, Open-Label Study Evaluating the Effect Of GW786034 In Subjects With Ovarian Cancer
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